Trial Outcomes & Findings for Collaborative Care for Women Veterans (NCT NCT02950961)

NCT ID: NCT02950961

Last Updated: 2024-03-18

Results Overview

Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 153 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-03-18

Participant Flow

123 patient participants; 30 provider participants

Participant milestones

Measure	Arm 1: Mixed Methods Implementation Evaluation The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Overall Study STARTED	123
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure

Arm 1: Mixed Methods Implementation Evaluation The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.

Overall Study Study had to stop due to COVID.

7

Baseline Characteristics

Collaborative Care for Women Veterans

Baseline characteristics by cohort

Measure	Arm 1: Mixed Methods Implementation Evaluation n=123 Participants The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Age, Continuous	38 years STANDARD_DEVIATION 11.24695 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 1 visit	48 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 2 visits	38 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 3 visits	18 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 4 visits	9 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 5 visits	4 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 6 visits	2 Participants n=5 Participants
number of mental health visits for the 30 days prior to care manager initiation 0 visits	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: 7 participants are not included here due to COVID shut down.

Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.

Outcome measures

Measure	Arm 1: Mixed Methods Implementation Evaluation n=116 Participants The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Change in Utilization of Services (30 Days) utilization decreased	53 Participants
Change in Utilization of Services (30 Days) no change in utilization	23 Participants
Change in Utilization of Services (30 Days) utilization increased	40 Participants

PRIMARY outcome

Timeframe: 60 days

Population: 7 participants are not included here due to COVID shut down.

Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.

Outcome measures

Measure	Arm 1: Mixed Methods Implementation Evaluation n=116 Participants The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Change in Utilization of Services (60 Days) utilization decreased	40 Participants
Change in Utilization of Services (60 Days) no change in utilization	14 Participants
Change in Utilization of Services (60 Days) utilization increased	62 Participants

PRIMARY outcome

Timeframe: 180 days

Population: 7 participants are not included here due to COVID shut down.

Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.

Outcome measures

Measure	Arm 1: Mixed Methods Implementation Evaluation n=116 Participants The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Change in Utilization of Services (180 Days) utilization decreased	29 Participants
Change in Utilization of Services (180 Days) no change in utliization	10 Participants
Change in Utilization of Services (180 Days) utilization increased	77 Participants

PRIMARY outcome

Timeframe: 365 days

Population: 7 participants are not included here due to COVID shut down.

Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.

Outcome measures

Measure	Arm 1: Mixed Methods Implementation Evaluation n=116 Participants The investigators used mixed methods to evaluate the implementation in two VA Women's Practice Based Research Network (PBRN) sites, describing services and patterns of care utilized by patients prior to seeing a care manager, and then 30, 60, 180, and 365 days post initiation of care with the care manager. Investigators also evaluated facilitators and barriers to implementation of this collaborative care model. Collaborative Care for Women Veterans: This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators offered in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators trained appropriate MH providers in CALM and studied the ways in which the intervention needs to be tailored to women Veterans.
Change in Utilization of Services (365 Days) utilization decreased	28 Participants
Change in Utilization of Services (365 Days) no change in utilization	8 Participants
Change in Utilization of Services (365 Days) utilization increased	80 Participants

PRIMARY outcome

Timeframe: baseline, 18 months (implementation phase)

Population: It was pre-specified that a sample size of at least 260 patients at a minimum of 4 sites was required. With only 116 patients across 2 sites, the final numbers were not sufficient to fit the nonrandomized stepped wedge model. Therefore, data were not collected.

Using the nonrandomized stepped wedge design, we will compare referrals to PC-MHI at baseline at each site, and compare to referrals throughout the 18-month implementation phase.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of patient engagement in care

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The outcome measure was on a patient survey that had administration deferred due to IRB delays. This led to only 5 six-month follow up patient surveys completed at 1 site. The sample (N=5) is less than 5% of the overall study sample and not representative. Privacy issues due to the potentially identifiable nature of such a small sample restrict us from any reporting, as our sample does not meet the VA National Data Systems threshold for reporting aggregate data to protect confidentiality.

brief measure of health literacy: (Chew et al. 2004)

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Mixed Methods Implementation Evaluation

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

Alison B Hamilton, PhD MPH

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Phone: (310) 478-3711

Email: alison.hamilton@va.gov

Results disclosure agreements

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