Trial Outcomes & Findings for Hybrid Collaborative Care Randomized Program Evaluation (NCT NCT02543840)

Last Updated: 2020-06-23

Results Overview

Veterans RAND-Mental Component Score: Overall self-rated mental health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Physical Component Score.

Recruitment status

COMPLETED

Study phase

Target enrollment

1112 participants

Primary outcome timeframe

one year

Results posted on

2020-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Veteran Participants In this stepped wedge design that is not a randomized control trial (RCT), those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.	Provider Participants In this stepped wedge design that is not a randomized control trial (RCT), BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.
Overall Study STARTED	1050	62
Overall Study 0 Month Timepoint (t0)	593	40
Overall Study 6 Month Timepoint (t6)	66	0
Overall Study 12 Month Timepoint (t12)	391	22
Overall Study COMPLETED	1050	62
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Provider ethnicity not collected.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: one year

Population: Adjusted mixed model of single group with repeated event. Number Analyzed = number of participants with available data at the specified time points. 1050 participants completed 1436 interviews across one or more time points: t0, t6, t12. 589 started at t0 (missing=4); 65 added at t6 (missing=1); 386 added at t12 (missing=5).

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Veterans RAND-12 Mental Component Score (VR-12 MCS) Baseline (T0)	36.82 score on a scale Standard Deviation 14.78
Veterans RAND-12 Mental Component Score (VR-12 MCS) Six Month Timepoint (T6)	36.24 score on a scale Standard Deviation 14.26
Veterans RAND-12 Mental Component Score (VR-12 MCS) Final Twelve Month Timepoint (T12)	37.25 score on a scale Standard Deviation 14.07

SECONDARY outcome

Timeframe: One year

Population: Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 593 started at t0; 66 added at t6; 391 added at t12. None missing from survey. Site included as random effect.

Veterans RAND-Physical Component Score: Overall self-rated physical health status over past two weeks among Veteran participants. Possible scores of minimum 0 and maximum 50. Higher is better. Administered with items for Veterans RAND-Mental Component Score.

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Veterans RAND-12 Physical Component Scores (VR-12 PCS) T0	35.20 score on a scale Standard Deviation 13.11
Veterans RAND-12 Physical Component Scores (VR-12 PCS) T6	35.62 score on a scale Standard Deviation 12.61
Veterans RAND-12 Physical Component Scores (VR-12 PCS) T12	35.30 score on a scale Standard Deviation 12.31

SECONDARY outcome

Timeframe: One year

Population: Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 576 started at t0 (missing=17); 64 added at t6 (missing=2); 380 added at t12 (missing=11). Site included as random effect.

Satisfaction Index: Overall patient satisfaction with mental health services. Higher is better. Minimum score is 12, maximum score is 72.

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Satisfaction Index T0	52.94 score on a scale Standard Deviation 14.40
Satisfaction Index T6	53.26 score on a scale Standard Deviation 15.08
Satisfaction Index T12	52.78 score on a scale Standard Deviation 15.18

SECONDARY outcome

Timeframe: One year

Population: Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 577 started at t0 (missing=16), 63 added at t6 (missing=3); 380 added at t12 (missing=11). Site included as random effect.

Recovery-oriented quality of life score. Higher is better. Minimum score 0, maximum score 100.

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Baseline (T0)	53.2 score on a scale Standard Deviation 19.33
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Six Month Timepoint (T6)	53.9 score on a scale Standard Deviation 20.82
Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Final Twelve Month Timepoint (T12)	54.8 score on a scale Standard Deviation 19.65

SECONDARY outcome

Timeframe: One year

Population: Adjusted mixed model of a single group with repeated event. Number Analyzed = number of participants with available data and the specified time points. 1050 completed 1436 interviews across t0, t6, t12. 582 started at t0 (missing=11); 65 added at t6 (missing=1); 384 added at t12 (missing=7). Site included as random effect.

Patient Assessment of Chronic Illness Care (PACIC): Veteran perception of coordination of and engagement with services. Higher is better. Minimum score is 1, maximum score is 33.

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Patient Assessment of Chronic Illness Care (PACIC) T0	21.94 score on a scale Standard Deviation 6.35
Patient Assessment of Chronic Illness Care (PACIC) T6	22.46 score on a scale Standard Deviation 6.57
Patient Assessment of Chronic Illness Care (PACIC) T12	21.99 score on a scale Standard Deviation 6.40

SECONDARY outcome

Timeframe: baseline and during stepdown (6-12 months)

Population: Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data at the specified time points for Cohesion domain (missing=3). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0.

Mean percentage of participant provider team members who strongly agreed or agreed with the cohesion domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.

Outcome measures

Outcome measures
Measure	Veteran Participants n=59 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Team Development Measure (TDM)- Cohesion Baseline (T0)	84.0 score on a scale Standard Deviation 20.8
Team Development Measure (TDM)- Cohesion Follow-up/Final at Six to Twelve Months (T12)	84.5 score on a scale Standard Deviation 22.4

SECONDARY outcome

Timeframe: baseline and during stepdown (6-12 months)

Population: Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data and the specified time points for Communication domain (missing=2). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0.

Mean percentage of participant team members who strongly agreed or agreed with the communication domain within the Team Development Measure. Measure Description: Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100.

Outcome measures

Outcome measures
Measure	Veteran Participants n=60 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Team Development Measure (TDM)- Communication Baseline (T0)	83.3 score on a scale Standard Deviation 24.6
Team Development Measure (TDM)- Communication Follow-up/Final at Six to Twelve Months (T12)	84.4 score on a scale Standard Deviation 20.6

SECONDARY outcome

Timeframe: baseline and during stepdown (6-12 months)

Population: Total 62 mental health providers who completed survey.Number Analyzed = number of participants with available data and the specified time points for Role Clarity domain (missing= 1). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0.

Mean percentage of participant team members who strongly agreed or agreed with the role clarity domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).

Outcome measures

Outcome measures
Measure	Veteran Participants n=61 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Team Development Measure (TDM)- Role Clarity Baseline (T0)	53.4 score on a scale Standard Deviation 26.9
Team Development Measure (TDM)- Role Clarity Follow-up/Final at Six to Twelve Months (T12)	68.7 score on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: baseline and during stepdown (6-12 months)

Population: Total 62 mental health providers who completed survey. Number Analyzed = number of participants with available data and the specified time points for Team Primacy (0 missing). 40 completed at 0 months (t0) and 43 completed at 12 months (t12). 21 new providers completed at t12; 22 completed at both t0 and t12. 19 completed only t0.

Mean percentage of participant team members who strongly agreed or agreed with the team primacy domain within the Team Development Measure. Measure Description: Team Development Measure (TDM) is a survey assessing team function at baseline and during the second six months of implementation using the four subscales with items rated from strongly agree to strongly disagree: Communication, Cohesion, Role Clarity, and Team Primacy (prioritizing team over individual goals). The percentage of team members agreeing or strongly agreeing with each statement was calculated, then averaged across all statements for a mean percentage for each subscale. Range of percentage was 0-100. Missing: cohesion (3); communication (2); role clarity (1); team primacy (0).

Outcome measures

Outcome measures
Measure	Veteran Participants n=62 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Team Development Measure (TDM)- Team Primacy Baseline (T0)	50.0 score on a scale Standard Deviation 37.6
Team Development Measure (TDM)- Team Primacy Follow-up/Final at Six to Twelve Months (T12)	68.6 score on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: Two years

Population: All eligible patients were coded for hospitalization yes/no in each quarter.

Quarterly indicator (0 not hospitalized or 1 hospitalized) for mental health hospitalization in the prior three months.

Outcome measures

Outcome measures
Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.
Mental Health Hospitalization Rates	-0.12 beta coefficient Interval -0.16 to -0.07

Adverse Events

Veteran Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Provider Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mark S. Bauer, MD

VA Boston Healthcare System- Center for Healthcare Organization and Implementation Research

Phone: 857-364-6380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Veteran Participants n=1050 Participants In this stepped wedge design, those eligible BHIP team-treated veterans randomly selected for telephone interview for health status measures. Primary analyses were within-subject.	Provider Participants n=62 Participants In this stepped wedge design, BHIP team clinicians who participated in team function survey. Primary analyses were within-subject.	Total n=1112 Participants Total of all reporting groups
Age, Continuous	53.9 years STANDARD_DEVIATION 13.7 • n=1050 Participants	49.6 years STANDARD_DEVIATION 9.9 • n=62 Participants	52.405 years STANDARD_DEVIATION 14.4 • n=1112 Participants
Sex: Female, Male Female	210 Participants n=1050 Participants	35 Participants n=62 Participants	245 Participants n=1112 Participants
Sex: Female, Male Male	840 Participants n=1050 Participants	27 Participants n=62 Participants	867 Participants n=1112 Participants
Race/Ethnicity, Customized White	825 Participants n=1050 Participants • Provider ethnicity not collected.	—	825 Participants n=1050 Participants • Provider ethnicity not collected.
Race/Ethnicity, Customized Black	159 Participants n=1050 Participants • Provider ethnicity not collected.	—	159 Participants n=1050 Participants • Provider ethnicity not collected.
Race/Ethnicity, Customized Other	26 Participants n=1050 Participants • Provider ethnicity not collected.	—	26 Participants n=1050 Participants • Provider ethnicity not collected.
Race/Ethnicity, Customized Hispanic or Latino	97 Participants n=1050 Participants • Provider ethnicity not collected.	—	97 Participants n=1050 Participants • Provider ethnicity not collected.
Race/Ethnicity, Customized Minority	275 Participants n=1050 Participants • Provider ethnicity not collected.	—	275 Participants n=1050 Participants • Provider ethnicity not collected.
Marital Status (currently married)	487 Participants n=1050 Participants • Marital status not collected for providers.	—	487 Participants n=1050 Participants • Marital status not collected for providers.
Employment Status (full-time, part-time, or self- employed)	532 Participants n=1050 Participants	62 Participants n=62 Participants	594 Participants n=1112 Participants
Rural residence (rural and highly rural)	227 Participants n=1050 Participants • Residence rurality not collected for providers.	—	227 Participants n=1050 Participants • Residence rurality not collected for providers.
Period of service (Gulf War or later, 1990-present)	497 Participants n=1050 Participants • Military service not collected for providers.	—	497 Participants n=1050 Participants • Military service not collected for providers.
VA disability % (>= 50%)	844 Participants n=1050 Participants • VA disability percentage (amount of disability assigned to VA patients that determines amount of care financially covered by VA). Not collected for providers.	—	844 Participants n=1050 Participants • VA disability percentage (amount of disability assigned to VA patients that determines amount of care financially covered by VA). Not collected for providers.
Depression or anxiety disorder	592 Participants n=1050 Participants • Diagnoses not collected for providers.	—	592 Participants n=1050 Participants • Diagnoses not collected for providers.
Serious Mental Illness (bipolar spectrum or schizophrenia)	340 Participants n=1050 Participants • Diagnoses not collected for providers.	—	340 Participants n=1050 Participants • Diagnoses not collected for providers.
Post traumatic stress disorder	474 Participants n=1050 Participants • Diagnoses not collected for providers.	—	474 Participants n=1050 Participants • Diagnoses not collected for providers.
Substance use disorder	169 Participants n=1050 Participants • Diagnoses not collected for providers.	—	169 Participants n=1050 Participants • Diagnoses not collected for providers.
Number of active mental health diagnoses (mean + sd)	2.2 diagnoses STANDARD_DEVIATION 1.4 • n=1050 Participants • Diagnoses not collected for providers.	—	2.2 diagnoses STANDARD_DEVIATION 1.4 • n=1050 Participants • Diagnoses not collected for providers.
Number of active medical diagnoses (mean + sd)	1.2 diagnoses STANDARD_DEVIATION 1.3 • n=1050 Participants • Diagnoses not collected for providers.	—	1.2 diagnoses STANDARD_DEVIATION 1.3 • n=1050 Participants • Diagnoses not collected for providers.
Mental health hospitalization in prior year	36 Participants n=1050 Participants • Hospitalizations not collected for providers.	—	36 Participants n=1050 Participants • Hospitalizations not collected for providers.
Medical-surgical hospitalization in prior year	73 Participants n=1050 Participants • Hospitalizations not collected for providers.	—	73 Participants n=1050 Participants • Hospitalizations not collected for providers.
Team Development Measure (TDM) Cohesion	—	84.0 scores on a scale STANDARD_DEVIATION 20.8 • n=59 Participants • Not collected for veterans participants (n=1050).	84.0 scores on a scale STANDARD_DEVIATION 20.8 • n=59 Participants • Not collected for veterans participants (n=1050).
Team Development Measure (TDM) Communication	—	83.3 scores on a scale STANDARD_DEVIATION 24.6 • n=60 Participants • Not collected for veterans participants (n=1050).	83.3 scores on a scale STANDARD_DEVIATION 24.6 • n=60 Participants • Not collected for veterans participants (n=1050).
Team Development Measure (TDM) Role Clarity	—	53.4 scores on a scale STANDARD_DEVIATION 26.9 • n=61 Participants • Not collected for veterans participants (n=1050).	53.4 scores on a scale STANDARD_DEVIATION 26.9 • n=61 Participants • Not collected for veterans participants (n=1050).
Team Development Measure (TDM) Team Primacy	—	50.0 scores on a scale STANDARD_DEVIATION 37.6 • n=62 Participants • Not collected for veterans participants (n=1050).	50.0 scores on a scale STANDARD_DEVIATION 37.6 • n=62 Participants • Not collected for veterans participants (n=1050).