Trial Outcomes & Findings for Implementing Health Plan-Level Care Management for Solo & Small Practices (NCT NCT02041962)
NCT ID: NCT02041962
Last Updated: 2019-04-23
Results Overview
Mental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
12-months
Results posted on
2019-04-23
Participant Flow
A total of 280 participants were consented and enrolled to participate. Of those 280 participants, only 238 completed the baseline survey and were randomized.
Participant milestones
| Measure |
Educational Control
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control
|
Chronic Care Model for Mood Disorders
Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
115
|
|
Overall Study
Participants Completing 6 mo. f/up
|
69
|
44
|
|
Overall Study
Participants Completing 12 mo. f/up
|
42
|
31
|
|
Overall Study
COMPLETED
|
42
|
31
|
|
Overall Study
NOT COMPLETED
|
81
|
84
|
Reasons for withdrawal
| Measure |
Educational Control
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control
|
Chronic Care Model for Mood Disorders
Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
|
|---|---|---|
|
Overall Study
Lost Aetna Coverage
|
43
|
40
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
37
|
32
|
|
Overall Study
Withdrawal by Subject
|
0
|
11
|
Baseline Characteristics
Implementing Health Plan-Level Care Management for Solo & Small Practices
Baseline characteristics by cohort
| Measure |
Educational Control
n=123 Participants
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control
|
Chronic Care Model for Mood Disorders
n=115 Participants
Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
|
Total
n=238 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
42.8 years
STANDARD_DEVIATION 12.9 • n=107 Participants
|
41.3 years
STANDARD_DEVIATION 13.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
94 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
193 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
29 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=99 Participants
|
115 participants
n=107 Participants
|
238 participants
n=206 Participants
|
|
Health-related Quality of Life - Mental Health Component Score
|
34.4 units on a scale
STANDARD_DEVIATION 15.2 • n=99 Participants
|
36.9 units on a scale
STANDARD_DEVIATION 15.3 • n=107 Participants
|
35.6 units on a scale
STANDARD_DEVIATION 15.2 • n=206 Participants
|
|
Mood Disorder Symptoms
|
12.4 units on a scale
STANDARD_DEVIATION 6.1 • n=99 Participants
|
13.0 units on a scale
STANDARD_DEVIATION 7.1 • n=107 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 6.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12-monthsMental Health Quality of Life was measured using the 12-item Short Form Survey (SF-12). The SF-12 has a scale range of 0-100 with higher values representing better outcomes.
Outcome measures
| Measure |
Educational Control
n=42 Participants
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control
|
Chronic Care Model for Mood Disorders
n=31 Participants
Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
|
|---|---|---|
|
Health-related Quality of Life, as Measured by the Mental Health Component Score
|
38.2 score on a scale
Standard Deviation 9.6
|
43.2 score on a scale
Standard Deviation 10.3
|
PRIMARY outcome
Timeframe: 12-monthsMood disorder symptoms were measured using the Patient Health Questionnaire (9-question). The PHQ-9 has a scale range of 0-27 with lower values representing better outcomes.
Outcome measures
| Measure |
Educational Control
n=42 Participants
Patients will receive their usual care from providers at their clinic. They will also receive in the mail a self-guided workbook.
Educational Control
|
Chronic Care Model for Mood Disorders
n=31 Participants
Life Goals Collaborative Care
Chronic Care Model for Mood Disorders: The mood disorders CCM intervention ("Life Goals Collaborative Care") consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session.
|
|---|---|---|
|
Mood Disorder Symptoms, as Measured by the Patient Health Questionnaire (9-question)
|
9.3 score on a scale
Standard Deviation 4.2
|
7.6 score on a scale
Standard Deviation 3.7
|
Adverse Events
Educational Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Chronic Care Model for Mood Disorders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place