Trial Outcomes & Findings for Coordination Toolkit and Coaching Project (NCT NCT03063294)
NCT ID: NCT03063294
Last Updated: 2023-07-27
Results Overview
The primary outcome was the 16-item Health Care System Hassles Scale. Recognized as a measure of care coordination, the Hassles questionnaire lists problems that patients may encounter with their general healthcare, as opposed to their care experience with one specific visit or provider. The questionnaire prompts patients to indicate how much situations such as "lack of information about why you've been referred to a specialist" have been a problem, using a 5-point scale ranging from 0 -4. Ratings were dichotomized (0 = "Not a problem at all" vs. 1 = any level of problem indicated) and summed to yield a hassles count ranging from 0 to 16, with higher scores indicating more hassles.
COMPLETED
NA
12 participants
Baseline and 12 months' follow-up
2023-07-27
Participant Flow
We recruited and enrolled VA primary care clinics from October 2016 to June 2018 using a multi-pronged approach, including teleconference presentations and direct outreach to regional and national leadership. Enrolled clinics participated in a 12-month quality improvement project.
Patient survey data were collected cross-sectionally at baseline and 12-months' follow-up to measure clinic outcomes. For the primary outcome (Health Care System Hassles Scale), both baseline and follow-up data are presented in the "outcomes" section; the primary measure of effectiveness depends on the change in outcome from baseline to follow-up.
Unit of analysis: Primary care clinics
Participant milestones
| Measure |
Toolkit Only
Clinics in this arm are given access to an online care coordination toolkit.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
|
Toolkit Plus Coaching
Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic.
|
|---|---|---|
|
Overall Study
STARTED
|
2463 6
|
2502 6
|
|
Overall Study
COMPLETED
|
2463 6
|
2502 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coordination Toolkit and Coaching Project
Baseline characteristics by cohort
| Measure |
Toolkit Only
n=6 Primary care clinics
Clinics in this arm are given access to an online care coordination toolkit.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
|
Toolkit Plus Coaching
n=6 Primary care clinics
Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic.
|
Total
n=12 Primary care clinics
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 65 or older
|
712 Participants
n=99 Participants
|
751 Participants
n=107 Participants
|
1463 Participants
n=206 Participants
|
|
Age, Customized
Age · Less than 65
|
508 Participants
n=99 Participants
|
463 Participants
n=107 Participants
|
971 Participants
n=206 Participants
|
|
Age, Customized
Age · Unknown
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
1036 Participants
n=99 Participants
|
1030 Participants
n=107 Participants
|
2066 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
180 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
361 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
|
704 Participants
n=99 Participants
|
684 Participants
n=107 Participants
|
1388 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black or African-American
|
137 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
279 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
142 Participants
n=99 Participants
|
182 Participants
n=107 Participants
|
324 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian or Asian-American
|
74 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other minority
|
27 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Multi-race/ethnicity
|
66 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
140 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown race/ethnicity
|
73 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 months' follow-upPopulation: These data derive from two cross-sectional participant surveys at separate (i.e., baseline and follow-up) timepoints. The numbers of participants shown here exceed the numbers presented in the Baseline module because respondents from the surveys are two separate (i.e., independent) samples of participants. Sample sizes for each arm are smaller than reported in the participant flow module because not all survey responses received had valid primary outcome data for analysis.
The primary outcome was the 16-item Health Care System Hassles Scale. Recognized as a measure of care coordination, the Hassles questionnaire lists problems that patients may encounter with their general healthcare, as opposed to their care experience with one specific visit or provider. The questionnaire prompts patients to indicate how much situations such as "lack of information about why you've been referred to a specialist" have been a problem, using a 5-point scale ranging from 0 -4. Ratings were dichotomized (0 = "Not a problem at all" vs. 1 = any level of problem indicated) and summed to yield a hassles count ranging from 0 to 16, with higher scores indicating more hassles.
Outcome measures
| Measure |
Toolkit Only
n=6 Primary care clinics
Clinics in this arm are given access to an online care coordination toolkit.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
|
Toolkit Plus Coaching
n=6 Primary care clinics
Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach.
Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic.
|
|---|---|---|
|
Health Care System Hassles Scale
Baseline
|
5.20 units on a scale
Interval 4.95 to 5.46
|
4.71 units on a scale
Interval 4.47 to 4.96
|
|
Health Care System Hassles Scale
12-month Follow-up
|
4.78 units on a scale
Interval 4.53 to 5.04
|
4.30 units on a scale
Interval 4.04 to 4.56
|
Adverse Events
Toolkit Only
Toolkit Plus Coaching
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Avram Ganz, MD, PhD
Veterans Affairs Greater Los Angeles Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place