Trial Outcomes & Findings for Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care (NCT NCT04000971)

NCT ID: NCT04000971

Last Updated: 2026-05-15

Results Overview

59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1196 participants

Primary outcome timeframe

12 months post-stroke

Results posted on

2026-05-15

Participant Flow

23 United States clinical sites were screened for site eligibility.

23 United States clinical sites were randomized stratified by region and admission volume.

Unit of analysis: Clinical sites

Participant milestones

Participant milestones
Measure
Integrated Stroke Practice Unit (ISPU)
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Baseline
STARTED
616 13
580 10
Baseline
COMPLETED
616 12
580 9
Baseline
NOT COMPLETED
0 1
0 1
Follow-Up
STARTED
616 12
580 9
Follow-Up
COMPLETED
417 12
528 9
Follow-Up
NOT COMPLETED
199 0
52 0

Reasons for withdrawal

Reasons for withdrawal
Measure
Integrated Stroke Practice Unit (ISPU)
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Follow-Up
Lost to Follow-up
68
17
Follow-Up
Withdrawal by Subject
61
31
Follow-Up
Not stated
10
4
Follow-Up
Fiscal limitations to protocol
55
0
Follow-Up
Moved outside of region
5
0

Baseline Characteristics

There were 2 participants whose discharge NIHSS score was missing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Integrated Stroke Practice Unit (ISPU)
n=616 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=580 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Total
n=1196 Participants
Total of all reporting groups
Age, Continuous
64.37 Years
STANDARD_DEVIATION 13.39 • n=616 Participants
63.80 Years
STANDARD_DEVIATION 13.14 • n=580 Participants
64.09 Years
STANDARD_DEVIATION 13.27 • n=1196 Participants
Sex: Female, Male
Female
281 Participants
n=616 Participants
261 Participants
n=580 Participants
542 Participants
n=1196 Participants
Sex: Female, Male
Male
335 Participants
n=616 Participants
319 Participants
n=580 Participants
654 Participants
n=1196 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
373 Participants
n=616 Participants
426 Participants
n=580 Participants
799 Participants
n=1196 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic Black
74 Participants
n=616 Participants
129 Participants
n=580 Participants
203 Participants
n=1196 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
152 Participants
n=616 Participants
9 Participants
n=580 Participants
161 Participants
n=1196 Participants
Race/Ethnicity, Customized
Race/Ethnicity · Other
17 Participants
n=616 Participants
16 Participants
n=580 Participants
33 Participants
n=1196 Participants
Discharge National Institutes of Health Stroke Scale (NIHSS)
Score=0
131 Participants
n=614 Participants • There were 2 participants whose discharge NIHSS score was missing.
183 Participants
n=580 Participants • There were 2 participants whose discharge NIHSS score was missing.
314 Participants
n=1194 Participants • There were 2 participants whose discharge NIHSS score was missing.
Discharge National Institutes of Health Stroke Scale (NIHSS)
Score=1
116 Participants
n=614 Participants • There were 2 participants whose discharge NIHSS score was missing.
141 Participants
n=580 Participants • There were 2 participants whose discharge NIHSS score was missing.
257 Participants
n=1194 Participants • There were 2 participants whose discharge NIHSS score was missing.
Discharge National Institutes of Health Stroke Scale (NIHSS)
Score=2-4
204 Participants
n=614 Participants • There were 2 participants whose discharge NIHSS score was missing.
161 Participants
n=580 Participants • There were 2 participants whose discharge NIHSS score was missing.
365 Participants
n=1194 Participants • There were 2 participants whose discharge NIHSS score was missing.
Discharge National Institutes of Health Stroke Scale (NIHSS)
Score=5+
163 Participants
n=614 Participants • There were 2 participants whose discharge NIHSS score was missing.
95 Participants
n=580 Participants • There were 2 participants whose discharge NIHSS score was missing.
258 Participants
n=1194 Participants • There were 2 participants whose discharge NIHSS score was missing.
Body Mass Index (BMI) at baseline
29.99 kg/m^2
STANDARD_DEVIATION 6.69 • n=616 Participants
30.45 kg/m^2
STANDARD_DEVIATION 7.95 • n=580 Participants
30.21 kg/m^2
STANDARD_DEVIATION 7.33 • n=1196 Participants

PRIMARY outcome

Timeframe: 12 months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=310 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=334 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Impact Scale (SIS) at 12-months Post-discharge
80.42 Score
Standard Deviation 21.28
83.85 Score
Standard Deviation 18.31

PRIMARY outcome

Timeframe: 12 months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or \>2. Overview of the Modified Rankin Scale * 0: No symptoms at all * 1: No significant disability; able to carry out all usual activities * 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk unassisted * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent, and requiring constant nursing care * 6: Dead

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=348 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=362 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Rankin Scale at 12 Months Post-stroke
0-2
214 Participants
255 Participants
Modified Rankin Scale at 12 Months Post-stroke
>2
134 Participants
107 Participants

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=353 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=335 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Impact Scale (SIS) at 3-months Post-discharge
78.88 score on a scale
Standard Deviation 21.07
80.97 score on a scale
Standard Deviation 20.78

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

59-item questionnaire to assess aspects of patient quality of life following stroke; includes 8 dimensions assessed on a 5-point Likert scale that are summed by domain. Scores range from 0-100, with higher scores indicating less difficulty.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=310 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=309 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Impact Scale (SIS) at 6-months Post-discharge
80.15 Score
Standard Deviation 21.66
81.39 Score
Standard Deviation 19.88

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or \>2. Overview of the Modified Rankin Scale * 0: No symptoms at all * 1: No significant disability; able to carry out all usual activities * 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk unassisted * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent, and requiring constant nursing care * 6: Dead

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=370 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=339 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Rankin Scale (mRS) at 3-months Post-discharge
0-2
227 Participants
239 Participants
Modified Rankin Scale (mRS) at 3-months Post-discharge
>2
143 Participants
100 Participants

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

The Modified Rankin Score (mRS) is a widely used scale to measure the degree of disability or dependence in daily activities of individuals who have suffered a stroke. Scores were categorized as 0-2 or \>2. Overview of the Modified Rankin Scale * 0: No symptoms at all * 1: No significant disability; able to carry out all usual activities * 2: Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance * 3: Moderate disability; requiring some help, but able to walk unassisted * 4: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance * 5: Severe disability; bedridden, incontinent, and requiring constant nursing care * 6: Dead

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=342 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=323 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Rankin Scale (mRS) at 6-months Post-discharge
0-2
208 Participants
219 Participants
Modified Rankin Scale (mRS) at 6-months Post-discharge
>2
134 Participants
104 Participants

SECONDARY outcome

Timeframe: 3-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=356 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=374 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge
In Control
200 Participants
164 Participants
Stroke Risk Factors - Blood Pressure Control (BP) at 3-months Post-discharge
Not in Control
156 Participants
210 Participants

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=317 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=330 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge
In Control
184 Participants
152 Participants
Stroke Risk Factors-Blood Pressure (BP) at 6-months Post-discharge
Not in Control
133 Participants
178 Participants

SECONDARY outcome

Timeframe: 12-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess BP control through measurement of a seated patient using a blood pressure cuff; controlled BP is 120-130/80 or below for ischemic stroke patients and 140/80 or below for hemorrhagic stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=316 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=334 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors-BP at 12-months Post-discharge
Not in Control
121 Participants
187 Participants
Stroke Risk Factors-BP at 12-months Post-discharge
In Control
195 Participants
147 Participants

SECONDARY outcome

Timeframe: 3-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=195 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=117 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge
In Control
113 Participants
61 Participants
Stroke Risk Factors - Cholesterol (LDL) at 3-months Post-discharge
Not in Control
82 Participants
56 Participants

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=132 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=77 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge
Not in Control
69 Participants
45 Participants
Stroke Risk Factors - Cholesterol (LDL) at 6-months Post-discharge
In Control
63 Participants
32 Participants

SECONDARY outcome

Timeframe: 12-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess LDL/lipids control through a LDL or lipids blood draw (standard of care) for patients with elevated cholesterol at baseline (prior to hospital discharge); controlled LDL is less than/equal to 70 for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=142 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=96 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge
In Control
81 Participants
40 Participants
Stroke Risk Factors - Cholesterol (LDL) at 12-months Post-discharge
Not in Control
61 Participants
56 Participants

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=136 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=67 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge
In Control
96 Participants
40 Participants
Stroke Risk Factors - Blood Sugar (HgBA1c) at 3-months Post-discharge
Not in Control
40 Participants
27 Participants

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=93 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=59 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge
In Control
66 Participants
34 Participants
Stroke Risk Factors - Blood Sugar (HgBA1c) at 6-months Post-discharge
Not in Control
27 Participants
25 Participants

SECONDARY outcome

Timeframe: 12-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess blood sugar control through a HgBA1c blood draw (standard of care) for patients with elevated blood sugar at baseline (prior to hospital discharge); controlled HgBA1c is less than/equal to 7% for stroke patients.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=109 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=71 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge
In Control
75 Participants
39 Participants
Stroke Risk Factors - Blood Sugar (HgBA1c) at 12-months Post-discharge
Not in Control
34 Participants
32 Participants

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m\*2=18.5-24.9 (BMI less than 18.5 kg/m\^2 is underweight, and BMI 25.0 kg/m\^2 or above is overweight (BMI=25.0-29.9 kg/m\^2 ) or obese (BMI=30.0 kg/m\^2 or above).

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=344 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=429 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 3-months Post-discharge
28.75 kg/m^2
Standard Deviation 5.83
29.66 kg/m^2
Standard Deviation 7.10

SECONDARY outcome

Timeframe: 6-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m\*2=18.5-24.9 (BMI less than 18.5 kg/m\^2 is underweight, and BMI 25.0 kg/m\^2 or above is overweight (BMI=25.0-29.9 kg/m\^2) or obese (BMI=30.0 kg/m2 or above).

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=301 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=390 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 6-months Post-discharge
28.50 kg/m^2
Standard Deviation 6.27
29.24 kg/m^2
Standard Deviation 6.98

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess weight status by measuring patients' weight and height and applying a formula; patients with normal weight have BMI kg/m\*2=18.5-24.9 (BMI less than 18.5 kg/m\^2 is underweight, and BMI 25.0 kg/m\^2 or above is overweight (BMI=25.0-29.9 kg/m\^2) or obese (BMI=30.0 kg/m\^2 or above). All measures are in kg/m\*2

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=295 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=380 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Body Mass Index (BMI) in kg/m^2 at 12-months Post-discharge
28.76 kg/m^2
Standard Deviation 6.17
29.06 kg/m^2
Standard Deviation 6.82

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=371 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=345 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Diet at 3-months Post-discharge
In Control
164 Participants
128 Participants
Stroke Risk Factors - Diet at 3-months Post-discharge
Not In Control
207 Participants
217 Participants

SECONDARY outcome

Timeframe: 6-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=326 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=318 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Diet at 6-months Post-discharge
In Control
129 Participants
96 Participants
Stroke Risk Factors - Diet at 6-months Post-discharge
Not In Control
197 Participants
222 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants were asked one yes/no question to measure awareness of and adherence to the DASH (Dietary Approaches to Stop Hypertension) eating plan and the Mediterranean Diet. Total number of yes scores is provided where a yes score indicates better adherence to the dietary pattern and therefore in control and a no answer indicated poorer adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=328 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=349 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Diet at 12-months Post-discharge
In Control
141 Participants
109 Participants
Stroke Risk Factors - Diet at 12-months Post-discharge
Not In Control
187 Participants
240 Participants

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=373 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=350 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge
Not In Control
30 Participants
40 Participants
Stroke Risk Factors - Smoking Status/Cessation at 3-months Post-discharge
In Control
343 Participants
310 Participants

SECONDARY outcome

Timeframe: 6-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=327 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=318 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge
Not In Control
28 Participants
35 Participants
Stroke Risk Factors - Smoking Status/Cessation at 6-months Post-discharge
In Control
299 Participants
283 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Participants who ever smoked were asked one yes/no question "Do you smoke now?" to measure compliance with the smoking cessation recommendation. Total number of participants answering yes indicates adherence to the smoking cessation recommendation pattern and therefore in-control while a no answer indicates non-adherence and not in control.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=331 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=349 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge
Not In Contol
22 Participants
39 Participants
Stroke Risk Factors - Smoking Status/Cessation at 12-months Post-discharge
In Control
309 Participants
310 Participants

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=372 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=347 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Exercise at 3-months Post-discharge
In Control
133 Participants
156 Participants
Stroke Risk Factors - Exercise at 3-months Post-discharge
Not In Control
239 Participants
191 Participants

SECONDARY outcome

Timeframe: 6-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=326 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=318 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Exercise at 6-months Post-discharge
In Control
126 Participants
119 Participants
Stroke Risk Factors - Exercise at 6-months Post-discharge
Not In Control
200 Participants
199 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

To assess self-reported adherence to American Stroke Association exercise guidelines (patients with stroke or transient ischemic attack (TIA) who are capable of at least moderate-intensity aerobic activity for a minimum of 10 minutes 4x per week, or vigorous intensity activity for a minimum of 20 minutes 2x per week is indicated) except as modified by the participants physician or physical therapist, Participants were asked one yes/no question to measure awareness of and adherence to the exercise recommendations Total number of participants with a yes score indicates adherence to the exercise recommendation pattern and therefore in-control while a no answer indicates non-adherence to the recommendation and not in control. .

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=330 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=349 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Stroke Risk Factors - Exercise at 12-months Post-discharge
In Control
152 Participants
155 Participants
Stroke Risk Factors - Exercise at 12-months Post-discharge
Not In Control
178 Participants
194 Participants

SECONDARY outcome

Timeframe: 12-months post-discharge

Mortality following stroke will be assessed with family member, through study personnel, and/or using public sources.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=616 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=580 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Mortality at 12-months Post-discharge
Deceased
39 Participants
30 Participants
Mortality at 12-months Post-discharge
Not Deceased
577 Participants
550 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements.

Rehospitalization following stroke will be assessed/confirmed with study personnel.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=614 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=580 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Rehospitalization
Rehospitalized
175 Participants
162 Participants
Rehospitalization
Not Rehospitalized
439 Participants
418 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements.

Recurrence of stroke will be assessed/confirmed with study personnel.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=614 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=580 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Recurrence
Recurrence
39 Participants
32 Participants
Recurrence
No Recurrence
575 Participants
548 Participants

SECONDARY outcome

Timeframe: 12-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements.

Time spent at home compared to institution assessed/confirmed with study personnel. Time at home is the proportion of time the participant spent at home out of their time at risk in this study (defined as being alive and with known status). The time at home is defined by subtracting time during hospitalization/rehabilitation/skilled nursing from the total time at risk and divided by total time at risk to get the proportion of time at home.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=597 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=564 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Time at Home
0.84 Proportion of Time
Standard Deviation 0.31
0.92 Proportion of Time
Standard Deviation 0.22

SECONDARY outcome

Timeframe: 3-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=379 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=466 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Depression: Patient Health Questionnaire (PHQ-9) at 3-months Post-discharge
3.66 Score
Standard Deviation 4.45
4.45 Score
Standard Deviation 4.79

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

Depression: Patient Health Questionnaire (PHQ-9) at 3-months post-discharge 9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=328 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=423 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Depression: Patient Health Questionnaire (PHQ-9) at 6-months Post-discharge
3.21 Score
Standard Deviation 4.15
3.88 Score
Standard Deviation 4.54

SECONDARY outcome

Timeframe: 12-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

9-item questionnaire to assess presence and/or severity of patient depression (includes an additional question to assess difficulty that doesn't impact scoring); scores range from 0-27, with 0=No depression, 1-4=Minimal depression, 5-9=Mild depression, 10-14=Moderate depression, 15-19=Moderately severe depression; and 20-27=Severe depression.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=317 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=405 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Depression: Patient Health Questionnaire (PHQ-9) at 12-months Post-discharge
2.58 Score
Standard Deviation 3.54
3.60 Score
Standard Deviation 4.24

SECONDARY outcome

Timeframe: 3-months post-stroke

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=126 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=176 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Caregiver Strain Index (mCSI) at 3-months Post-discharge
5.39 Score
Standard Deviation 5.27
5.38 Score
Standard Deviation 6.18

SECONDARY outcome

Timeframe: 6-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

13-item questionnaire to assess the level of strain in caregivers, with higher scores indicating increased caregiver strain.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=95 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=162 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Caregiver Strain Index (mCSI) at 6-months Post-discharge
5.20 Score
Standard Deviation 5.69
4.60 Score
Standard Deviation 5.80

SECONDARY outcome

Timeframe: 12-months post-discharge

Population: Analysis population reflects the number of participants with non-missing measurements at this timepoint.

13-item questionnaire to assess the level of strain in caregivers. Scores can range from 0-26, with higher scores indicating increased caregiver strain. Mean scores for each arm are provided and standard deviation of the mean.

Outcome measures

Outcome measures
Measure
Integrated Stroke Practice Unit (ISPU)
n=93 Participants
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=156 Participants
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Modified Caregiver Strain Index (mCSI) at 12-months Post-discharge
6.12 Score
Standard Deviation 6.84
4.15 Score
Standard Deviation 5.78

Adverse Events

Integrated Stroke Practice Unit (ISPU)

Serious events: 177 serious events
Other events: 0 other events
Deaths: 39 deaths

Comprehensive or Primary Stroke Center (CSC/PSC)

Serious events: 162 serious events
Other events: 0 other events
Deaths: 30 deaths

Serious adverse events

Serious adverse events
Measure
Integrated Stroke Practice Unit (ISPU)
n=616 participants at risk
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
n=580 participants at risk
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, and 12 months; secondary outcomes will be assessed at 3, 6, and 12 months.
General disorders
Hospitalization
28.4%
175/616 • From discharge to 12-months post-discharge
An independent Data Safety Monitoring Board (DSMB) met and monitored safety during the C3FIT trial. During an initial meeting, the DSMB and study team decided safety monitoring would focus on one event, mortality, due to the pragmatic study design and nature of the intervention.
27.9%
162/580 • From discharge to 12-months post-discharge
An independent Data Safety Monitoring Board (DSMB) met and monitored safety during the C3FIT trial. During an initial meeting, the DSMB and study team decided safety monitoring would focus on one event, mortality, due to the pragmatic study design and nature of the intervention.
General disorders
Stroke Recurrence
6.3%
39/616 • From discharge to 12-months post-discharge
An independent Data Safety Monitoring Board (DSMB) met and monitored safety during the C3FIT trial. During an initial meeting, the DSMB and study team decided safety monitoring would focus on one event, mortality, due to the pragmatic study design and nature of the intervention.
5.5%
32/580 • From discharge to 12-months post-discharge
An independent Data Safety Monitoring Board (DSMB) met and monitored safety during the C3FIT trial. During an initial meeting, the DSMB and study team decided safety monitoring would focus on one event, mortality, due to the pragmatic study design and nature of the intervention.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Gaines

Vanderbilt University Medical Center

Phone: 803-476-2976

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place