Trial Outcomes & Findings for Implementing a Blended Care Model That Integrates Mental Healthcare and Primary Care Using Telemedicine and Care Management for Patients With Depression or Alcohol Use Disorder in Small Primary Care Clinics (NCT NCT02713217)
NCT ID: NCT02713217
Last Updated: 2024-09-04
Results Overview
Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up on the Mental Component Summary scale of the Veterans Rand 12-item Health Survey. Measure Description: The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher (positive) change score represents greater improvement in mental health-related quality of life from study enrollment to follow-up. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0.
COMPLETED
318 participants
Six months
2024-09-04
Participant Flow
Participant milestones
| Measure |
Usual Care (Pre-Implementation) Cohort
Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs.
Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
|
Blended Telemedicine-Based Care (Post-Implementation) Cohort
Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model.
Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
|
|---|---|---|
|
Overall Study
STARTED
|
279
|
39
|
|
Overall Study
COMPLETED
|
223
|
34
|
|
Overall Study
NOT COMPLETED
|
56
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
Baseline characteristics by cohort
| Measure |
Usual Care (Pre-Implementation) Cohort
n=279 Participants
Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs.
Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
|
Blended Telemedicine-Based Care (Post-Implementation) Cohort
n=39 Participants
Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model.
Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 14.8 • n=279 Participants
|
48.9 years
STANDARD_DEVIATION 16.6 • n=39 Participants
|
53.0 years
STANDARD_DEVIATION 15.0 • n=318 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=279 Participants
|
7 Participants
n=39 Participants
|
29 Participants
n=318 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=279 Participants
|
32 Participants
n=39 Participants
|
289 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=279 Participants
|
1 Participants
n=39 Participants
|
7 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
272 Participants
n=279 Participants
|
38 Participants
n=39 Participants
|
310 Participants
n=318 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=318 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
1 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Black or African American
|
93 Participants
n=279 Participants
|
7 Participants
n=39 Participants
|
100 Participants
n=318 Participants
|
|
Race (NIH/OMB)
White
|
165 Participants
n=279 Participants
|
32 Participants
n=39 Participants
|
197 Participants
n=318 Participants
|
|
Race (NIH/OMB)
More than one race
|
17 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
17 Participants
n=318 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=279 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=318 Participants
|
|
Region of Enrollment
United States
|
279 Participants
n=279 Participants
|
39 Participants
n=39 Participants
|
318 Participants
n=318 Participants
|
|
VR-12 MCS
|
39.7 units on a scale
STANDARD_DEVIATION 13.5 • n=279 Participants
|
38.2 units on a scale
STANDARD_DEVIATION 13.7 • n=39 Participants
|
39.5 units on a scale
STANDARD_DEVIATION 13.5 • n=318 Participants
|
|
Employment
Retired
|
73 Participants
n=279 Participants
|
6 Participants
n=39 Participants
|
79 Participants
n=318 Participants
|
|
Employment
Other
|
108 Participants
n=279 Participants
|
12 Participants
n=39 Participants
|
120 Participants
n=318 Participants
|
|
Non-VA Health Insurance Status
|
163 Participants
n=279 Participants
|
21 Participants
n=39 Participants
|
184 Participants
n=318 Participants
|
|
Clinical Depression Screen Positive
|
116 Participants
n=279 Participants
|
17 Participants
n=39 Participants
|
133 Participants
n=318 Participants
|
|
Clinical Alcohol Screening Test - Positive
|
106 Participants
n=279 Participants
|
22 Participants
n=39 Participants
|
128 Participants
n=318 Participants
|
|
Clinical PTSD Screening - Positive
|
105 Participants
n=279 Participants
|
1 Participants
n=39 Participants
|
106 Participants
n=318 Participants
|
|
PHQ-9
|
11.2 units on a scale
STANDARD_DEVIATION 6.3 • n=279 Participants
|
11.3 units on a scale
STANDARD_DEVIATION 6.3 • n=39 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 6.3 • n=318 Participants
|
|
AUDIT-C Total Score
|
3.6 units on a scale
STANDARD_DEVIATION 3.5 • n=279 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 2.9 • n=39 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 3.4 • n=318 Participants
|
|
PCL-5
|
30.4 units on a scale
STANDARD_DEVIATION 17.6 • n=279 Participants
|
29.2 units on a scale
STANDARD_DEVIATION 17.4 • n=39 Participants
|
30.3 units on a scale
STANDARD_DEVIATION 17.6 • n=318 Participants
|
|
Hoge Barriers Assessment
|
33.9 units on a scale
STANDARD_DEVIATION 8.8 • n=279 Participants
|
33.1 units on a scale
STANDARD_DEVIATION 9.9 • n=39 Participants
|
33.8 units on a scale
STANDARD_DEVIATION 8.9 • n=318 Participants
|
|
Readiness Ruler
Readiness 1
|
6.0 units on a scale
n=279 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
7.0 units on a scale
n=39 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
6.0 units on a scale
n=318 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
|
Readiness Ruler
Readiness 2
|
8.0 units on a scale
n=273 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
8.0 units on a scale
n=38 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
8.0 units on a scale
n=311 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
|
Readiness Ruler
Readiness 3
|
7.0 units on a scale
n=276 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
8.0 units on a scale
n=39 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
7.0 units on a scale
n=315 Participants • There were missing data for Readiness 2 and Readiness 3 measures for a few participants.
|
|
Pain Scale
|
5.1 units on a scale
STANDARD_DEVIATION 2.7 • n=279 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 2.9 • n=39 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 2.7 • n=318 Participants
|
|
Jenkins Sleep Scale
|
14.0 units on a scale
n=271 Participants • Missing data for 8 participants in the pre-implementation participant group.
|
16.0 units on a scale
n=39 Participants • Missing data for 8 participants in the pre-implementation participant group.
|
14.0 units on a scale
n=310 Participants • Missing data for 8 participants in the pre-implementation participant group.
|
|
GAD-7
|
9.1 units on a scale
STANDARD_DEVIATION 6.0 • n=279 Participants
|
10.4 units on a scale
STANDARD_DEVIATION 6.1 • n=39 Participants
|
9.3 units on a scale
STANDARD_DEVIATION 6.0 • n=318 Participants
|
|
Severity Measure for Panic - Adult
|
12.1 units on a scale
STANDARD_DEVIATION 8.6 • n=142 Participants • Total score presented here only applies to participants who reported ever having a panic attack.
|
10.6 units on a scale
STANDARD_DEVIATION 8.6 • n=22 Participants • Total score presented here only applies to participants who reported ever having a panic attack.
|
11.9 units on a scale
STANDARD_DEVIATION 8.6 • n=164 Participants • Total score presented here only applies to participants who reported ever having a panic attack.
|
|
BRFSS Tobacco Use
|
109 Participants
n=197 Participants • This item was assessed for participants who answered the first question, "Have you smoked at least 100 cigarettes in your entire life?" in the affirmative.
|
10 Participants
n=24 Participants • This item was assessed for participants who answered the first question, "Have you smoked at least 100 cigarettes in your entire life?" in the affirmative.
|
119 Participants
n=221 Participants • This item was assessed for participants who answered the first question, "Have you smoked at least 100 cigarettes in your entire life?" in the affirmative.
|
|
CSQ-8
|
27.0 units on a scale
n=278 Participants • One participant in the pre-implementation participant group had missing data on this scale.
|
28.0 units on a scale
n=39 Participants • One participant in the pre-implementation participant group had missing data on this scale.
|
27.0 units on a scale
n=317 Participants • One participant in the pre-implementation participant group had missing data on this scale.
|
|
VR-12 PCS
|
32.7 units on a scale
STANDARD_DEVIATION 13.6 • n=279 Participants
|
36.8 units on a scale
STANDARD_DEVIATION 13.6 • n=39 Participants
|
33.2 units on a scale
STANDARD_DEVIATION 13.6 • n=318 Participants
|
|
Marital Status
|
164 Participants
n=279 Participants
|
23 Participants
n=39 Participants
|
187 Participants
n=318 Participants
|
|
Education
High School or Less
|
107 Participants
n=279 Participants
|
8 Participants
n=39 Participants
|
115 Participants
n=318 Participants
|
|
Education
Some College
|
118 Participants
n=279 Participants
|
13 Participants
n=39 Participants
|
131 Participants
n=318 Participants
|
|
Education
College Degree or More
|
54 Participants
n=279 Participants
|
18 Participants
n=39 Participants
|
72 Participants
n=318 Participants
|
|
Employment
Full-Time or Part-Time
|
98 Participants
n=279 Participants
|
21 Participants
n=39 Participants
|
119 Participants
n=318 Participants
|
PRIMARY outcome
Timeframe: Six monthsPopulation: The number of participants analyzed for each cohort is somewhat less than the number of total participants in each group (1) because of loss to follow-up and (2) because participants who only screened positive for PTSD were not included in this analysis.
Change in overall mental health functioning from study enrollment (after screening positive for depressive disorder or alcohol use disorder) to six-month follow-up on the Mental Component Summary scale of the Veterans Rand 12-item Health Survey. Measure Description: The Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) is a normed scale, presented as a T-score that is standardized to the US population. The population mean MCS score is 50 and standard deviation is 10, with scores ranging from 0-100. A higher (positive) change score represents greater improvement in mental health-related quality of life from study enrollment to follow-up. The VR-12 was developed from the Veterans RAND 36-Item Health Survey (VR-36), which was developed from the Medical Outcomes Study RAND SF-36(TM) Version 1.0.
Outcome measures
| Measure |
Usual Care (Pre-Implementation) Cohort
n=172 Participants
Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs.
Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
|
Blended Telemedicine-Based Care (Post-Implementation) Cohort
n=33 Participants
Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model.
Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
|
|---|---|---|
|
Change in VR-12 Mental Component Summary Scores
|
2.9 score on a scale
Standard Deviation 11.8
|
5.1 score on a scale
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: Six monthsPopulation: The numbers of participants analyzed in each cohort for this measure is less than the total number of participants (1) because this analysis only included participants who had screened positive for depression and (2) because of loss to follow-up.
Change in depressive symptoms as measured by Patient Health Questionnaire (PHQ-9) from study enrollment to six-month follow-up, for patients screening positive for depressive disorders at baseline. The possible range of scores on the PHQ-9 is 0-27, with higher scores indicating more severe depressive symptoms. A negative change score represents improvement in depressive symptoms.
Outcome measures
| Measure |
Usual Care (Pre-Implementation) Cohort
n=116 Participants
Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs.
Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
|
Blended Telemedicine-Based Care (Post-Implementation) Cohort
n=17 Participants
Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model.
Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
|
|---|---|---|
|
Change in PHQ-9 Scores
|
-2.3 score on a scale
Standard Deviation 6.0
|
-3.2 score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, Six monthsPopulation: Participants are included in this analysis if they screened positive for alcohol use disorder (clinical screen) before enrollment. The number of participants analyzed is lower than the total enrolled in the study because many participants did not screen positive for alcohol use disorder. At 6-month follow-up assessment, some participants were lost to follow-up.
Change in alcohol use symptoms from study enrollment to six-month follow-up, for patients screening positive for alcohol use disorders at baseline. The analysis used the Alcohol Use Disorders Identification Test (AUDIT-C) Total Score. The possible range of scores is 0-12, with higher scores indicating greater alcohol use.
Outcome measures
| Measure |
Usual Care (Pre-Implementation) Cohort
n=106 Participants
Eligible patients will be recruited and enrolled prior to implementation of the blended integrated care model in each study site. They will be exposed to care as usual in the CBOCs.
Usual Care: This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
|
Blended Telemedicine-Based Care (Post-Implementation) Cohort
n=22 Participants
Eligible patients will be recruited and enrolled following implementation of the blended integrated care model in each study site. These participants are thus exposed to the "intervention" model.
Blended Telemedicine-Based Integrated Care: This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and "virtual co-location" of doctoral-level mental health providers with prompt access through tele-video or telephone communication.
|
|---|---|---|
|
Change in AUDIT-C Scores
Baseline assessment
|
6.8 units on a scale
Standard Deviation 2.8
|
6.5 units on a scale
Standard Deviation 1.7
|
|
Change in AUDIT-C Scores
6-month follow-up assessment
|
6.4 units on a scale
Standard Deviation 2.7
|
6.1 units on a scale
Standard Deviation 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-24 monthsProportion of primary care providers with at least one patient with a Primary Care-Mental Health Integration encounter following implementation of the blended, integrated care model. The time frame is variable due to the stepped wedge design.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Six monthsProportion of patients having any mental health encounter in the six month follow-up period.
Outcome measures
Outcome data not reported
Adverse Events
Pre-Implementation Cohort
Post-Implementation Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Richard R. Owen, MD
Central Arkansas Veterans Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place