Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2025-12-25 @ 12:21 PM
Study NCT ID:
NCT02950961
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2016-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Collaborative Care for Women Veterans
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alison.hamilton@va.gov', 'phone': '(310) 478-3711', 'title': 'Alison B Hamilton, PhD MPH', 'phoneExt': '44157', 'organization': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Our implementation outcomes were assessed using qualitative methods'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year', 'description': 'Adverse events were monitored only for patients who were enrolled in the survey and interview research components, but not for patients whose deidentified clinical data were used for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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.", 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 0, 'seriousNumAtRisk': 123, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Utilization of Services (30 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'classes': [{'categories': [{'title': 'utilization decreased', 'measurements': [{'value': '53', 'groupId': 'OG000'}]}, {'title': 'no change in utilization', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'utilization increased', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants are not included here due to COVID shut down.'}, {'type': 'PRIMARY', 'title': 'Change in Utilization of Services (60 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'classes': [{'categories': [{'title': 'utilization decreased', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'no change in utilization', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'utilization increased', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '60 days', 'description': 'Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants are not included here due to COVID shut down.'}, {'type': 'PRIMARY', 'title': 'Change in Utilization of Services (180 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'classes': [{'categories': [{'title': 'utilization decreased', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'no change in utliization', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'utilization increased', 'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days', 'description': 'Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants are not included here due to COVID shut down.'}, {'type': 'PRIMARY', 'title': 'Change in Utilization of Services (365 Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'classes': [{'categories': [{'title': 'utilization decreased', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'no change in utilization', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'utilization increased', 'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '365 days', 'description': 'Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '7 participants are not included here due to COVID shut down.'}, {'type': 'PRIMARY', 'title': 'Change in Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': 'baseline, 18 months (implementation phase)', 'description': '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.', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Patient-Reported Outcomes Measurement Information System (PROMIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Overall Anxiety Severity and Impairment Scale (OASIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Patient Health Questionnaire for Depression and Anxiety (PHQ-4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Global Rating of Satisfaction/Quality of Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Altarum Consumer Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of patient engagement in care', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'PRIMARY', 'title': 'Health Literacy (Chew et al. 2004)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'timeFrame': '6 months', 'description': 'brief measure of health literacy: (Chew et al. 2004)', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Study had to stop due to COVID.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': '123 patient participants; 30 provider participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.\n\nCollaborative 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."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '11.24695', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'number of mental health visits for the 30 days prior to care manager initiation', 'classes': [{'categories': [{'title': '1 visit', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': '2 visits', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': '3 visits', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '4 visits', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '5 visits', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '6 visits', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '0 visits', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Describing services and patterns of care utilized by patients for the 30 days prior to seeing a care manager.', 'unitOfMeasure': 'Participants'}], 'populationDescription': '123 baseline patient participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-22', 'size': 972966, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-18T20:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2016-10-21', 'resultsFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2016-10-27', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-30', 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Utilization of Services (30 Days)', 'timeFrame': '30 days', 'description': 'Change in utilization of services comparing utilization 30 days prior to 30 days post initiation of care with the care manager.'}, {'measure': 'Change in Utilization of Services (60 Days)', 'timeFrame': '60 days', 'description': 'Change in utilization of services comparing utilization 60 days prior to 60 days post initiation of care with the care manager.'}, {'measure': 'Change in Utilization of Services (180 Days)', 'timeFrame': '180 days', 'description': 'Change in utilization of services 180 days prior to 180 days post initiation of care with the care manager.'}, {'measure': 'Change in Utilization of Services (365 Days)', 'timeFrame': '365 days', 'description': 'Change in utilization of services comparing utilization 365 days prior to 365 days post initiation of care with the care manager.'}, {'measure': 'Change in Referrals', 'timeFrame': 'baseline, 18 months (implementation phase)', 'description': '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.'}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': '6 months', 'description': 'brief measure of global health: Patient-Reported Outcomes Measurement Information System (PROMIS)'}, {'measure': 'Overall Anxiety Severity and Impairment Scale (OASIS)', 'timeFrame': '6 months', 'description': 'brief measure of anxiety: Overall Anxiety Severity and Impairment Scale (OASIS)'}, {'measure': 'Patient Health Questionnaire for Depression and Anxiety (PHQ-4)', 'timeFrame': '6 months', 'description': 'brief measure of depression: Patient Health Questionnaire for Depression and Anxiety (PHQ-4)'}, {'measure': 'WHO Disability Assessment Schedule (WHODAS) Out Of Role Days Items', 'timeFrame': '6 months', 'description': 'brief measure of impact of disability on role functioning: WHO Disability Assessment Schedule (WHODAS) Out Of Role Days items'}, {'measure': 'Global Rating of Satisfaction/Quality of Care', 'timeFrame': '6 months', 'description': 'brief measure of satisfaction and quality that we have used in several surveys of women Veteran VA patients'}, {'measure': 'Altarum Consumer Engagement', 'timeFrame': '6 months', 'description': 'brief measure of patient engagement in care'}, {'measure': 'Health Literacy (Chew et al. 2004)', 'timeFrame': '6 months', 'description': 'brief measure of health literacy: (Chew et al. 2004)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety [F01.470.132]', 'Depression [F01.145.126.350]', 'Stress Disorders, Post-Traumatic [F03.950.750.500]', 'Primary Health Care [N04.590.233.727]', 'Mental Health [F02.418]', 'Patient Satisfaction [N05.300.150.600.630]', 'Patient Preference [N05.300.150.600.630.500]', 'Physicians, Primary Care [M01.526.485.810.800]', 'Physicians, Women [M01.526.485.810.820]', 'Health Behavior [F01.145.488]'], 'conditions': ['Anxiety', 'Depression', 'Stress Disorders, Post Traumatic']}, 'referencesModule': {'references': [{'pmid': '30482159', 'type': 'DERIVED', 'citation': 'Finley EP, Huynh AK, Farmer MM, Bean-Mayberry B, Moin T, Oishi SM, Moreau JL, Dyer KE, Lanham HJ, Leykum L, Hamilton AB. Periodic reflections: a method of guided discussions for documenting implementation phenomena. BMC Med Res Methodol. 2018 Nov 27;18(1):153. doi: 10.1186/s12874-018-0610-y.'}, {'pmid': '29116022', 'type': 'DERIVED', 'citation': 'Hamilton AB, Farmer MM, Moin T, Finley EP, Lang AJ, Oishi SM, Huynh AK, Zuchowski J, Haskell SG, Bean-Mayberry B. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER): a protocol for a program of research. Implement Sci. 2017 Nov 7;12(1):127. doi: 10.1186/s13012-017-0658-9.'}]}, 'descriptionModule': {'briefSummary': "Implementation of Tailored Collaborative Care for Women Veterans (CCWV) was designed to enhance primary care-mental health integration for women Veterans by tailoring services to women Veterans' and providers' needs and providing an evidence-based intervention, Coordinated Anxiety Learning and Management, to address anxiety and depression in a patient-centered approach. CCWV was implemented in two of the Women's Health Practice-Based Research Network sites, with careful attention to local tailoring and adaptation to enhance the fit of the care model in varied local contexts.", 'detailedDescription': 'Background: Women Veterans are the fastest growing segment of Veterans Health Administration (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety, and mental health comorbidity are disproportionately high among women Veterans. Furthermore, a high rate of women Veterans\' attrition from VA care, along with organizational barriers to care, substantiate that organizational changes are needed in order to engage and retain women Veteran VHA users in evidence-based, patient-centered care.\n\nObjectives: The Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing "personalized, proactive, patient-centered" care models, and Transformational Strategy 7.2.g by implementation of innovative care models in women Veterans\' health care." The EMPOWER QUERI Program was designed to improve women Veterans\' engagement and retention in evidence-based care for three high priority health conditions, i.e., prediabetes, cardiovascular, and mental health. To achieve this impact goal, the investigators proposed a cohesive portfolio of projects with the following aims: (1) To use an evidence-based implementation strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement, and systematic evaluation of complex implementation processes in order to enrich organizational capacity for innovations in women Veterans\' VHA health care; (2) To implement personalized, proactive, patient-centered innovations in VHA women\'s health that are acceptable, feasible, satisfactory, relevant, and effective for both providers and patients, thereby encouraging women Veterans\' engagement and retention and sustainability of the innovations; and, (3) To generate implementation "playbooks" for the investigators\' partners that are scalable and serve as guidance for future implementation of a broader array of evidence-based women\'s health programs and policy.\n\nMethods: Three projects were conducted by an experienced multidisciplinary team. This trial pertains to "Implementation of Tailored Collaborative Care for Women Veterans," which evaluated implementation of an evidence-based collaborative care model tailored to enhance provider- and system-level capabilities to address women Veterans\' anxiety and depression treatment needs, thereby improving organizational primary care-mental health integration (PC-MHI) effectiveness and women Veterans\' engagement and retention in PC-MHI. This implementation research study used mixed methods implementation evaluation to investigate primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement was prioritized. Program-wide organizational-, provider-, and patient-level data was utilized to enhance synergy, productivity, and impact. Several implementation outcomes were assessed using qualitative methods and will be reported elsewhere (e.g. final report, manuscripts).These include Adoption of Care Model, Acceptability of Care Model, Feasibility of Care Model, and Satisfaction With Care Model.\n\nAs a coherent program of women\'s health implementation research and quality improvement, the EMPOWER QUERI constituted a major milestone in achieving Blueprint for Excellence (BPE) strategies and realizing women Veterans\' engagement and, ultimately, empowerment in the VHA system.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD.\n\nParticipant eligibility is based on self-representation of gender identity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatient Participants:\n\n* Women VA patients with possible or confirmed anxiety and/or depression and/or PTSD\n\nProvider Participants:\n\n* VA staff in a primary care and/or mental health clinic\n\n * Note: gender based inclusion criteria did not apply to provider participants\n\nExclusion Criteria\n\nPatient Participants:\n\n* Male gender\n* Cognitive impairment that would preclude completion of informed consent\n\nProvider Participants:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02950961', 'acronym': 'CCWV', 'briefTitle': 'Collaborative Care for Women Veterans', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Implementation of Tailored Collaborative Care For Women Veterans (CCWV) (QUE 15-272)', 'orgStudyIdInfo': {'id': 'QUX 16-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1: Mixed Methods Implementation Evaluation', 'description': "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.", 'interventionNames': ['Behavioral: Collaborative Care for Women Veterans']}], 'interventions': [{'name': 'Collaborative Care for Women Veterans', 'type': 'BEHAVIORAL', 'otherNames': ['Gender-Tailored Primary Care-Mental Health Integration'], 'description': '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.', 'armGroupLabels': ['Arm 1: Mixed Methods Implementation Evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA San Diego Healthcare System, San Diego, CA', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90073', 'city': 'West Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA', 'geoPoint': {'lat': 34.0462, 'lon': -118.43068}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'VA Portland Health Care System, Portland, OR', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Alison B Hamilton, PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Greater Los Angeles Healthcare System, West Los Angeles, CA'}, {'name': 'Ariel J. Lang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA San Diego Healthcare System, San Diego, CA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}