- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898879
Enhancing Veteran-Clinical Collaboration in VA PRRCs (EVCC VPRRC)
Enhancing Veteran-Clinical Collaboration in VA Psychosocial Rehabilitation and Recovery Centers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recovery-oriented care is an imperative for the VA, particularly in mental health programming for Veterans with serious mental illness (SMI). Collaborative decision-making (CDM) is a recovery-oriented approach to treatment decision-making that supports meaningful involvement for patients across all aspects of decision- making, thereby empowering patients and facilitating better decision-making based on patient values, preferences, and cultural context. CDM is associated with several important outcomes including improved personal recovery, treatment engagement, treatment satisfaction, and social functioning. However, current levels of CDM among Veterans with SMI are low. Collaborative Decision Skills Training (CDST) is a promising 10-session group intervention that support Veterans to gain knowledge, skills, comfort, and confidence to collaborate with their clinicians and other members of their treatment teams. CDST has undergone initial testing in a VA Psychosocial Rehabilitation and Recovery Center (PRRC) and demonstrated feasibility for use among Veterans participating in PRRC care. This initial tests demonstrated preliminary evidence that CDST is effective at increasing Veteran-clinician collaboration, personal recovery, empowerment, treatment engagement, and social functioning.
Therefore, the proposed study will examine CDST's effectiveness among 119 Veterans with SMI participating in three PRRCs in the Southwestern United States (San Diego, Los Angeles, and Albuquerque). Veterans will be randomized to either CDST or active control (AC). The primary outcome measure will be functioning within the rehabilitation context, meaning Veteran CDM behavior during usual care VA mental health appointments. Secondary outcomes are treatment attendance, engagement, and satisfaction, along with functioning outside of the rehabilitation context (i.e., rehabilitation goal attainment, sense of personal recovery, empowerment symptom severity, and social functioning). Given that CDM is fundamentally an interaction between Veterans and their clinicians, the team will also assess whether clinician factors (i.e., engagement in CDST training or delivery; therapeutic alliance; work satisfaction; burnout; perceptions of self-efficacy; organizational climate; attitudes about recovery and CDM) moderate Veteran outcomes. Veterans in both groups will attend 10 hour- long group sessions held over 10 weeks.
All Veterans will complete an assessment battery at baseline, post-intervention, at three-month post- intervention follow-up, and at six-month follow-up. This will allow the team to assess durability of CDST's hypothesized benefits. Veterans who leave PRRC care and then return while the study is still active will complete one final assessment to further assess whether benefits are durable to re-entry to care. Additionally, the team will assess equity of benefits by assessing subgroup differences in benefits by race/ethnicity, gender, and sexual orientation. A team of Veterans and clinicians will be recruited to co-create consensus equity guidelines to support effective and equitable delivery of CDST in PRRCs.
The results of the proposed study will confirm CDST's benefits for Veterans in PRRC care and inform the utility of providing CDST broadly to Veterans with SMI. The results of this study will expand current understanding of CDM among Veterans with SMI by providing a large, diverse sample to 1) assess CDST's overall benefits; 2) durability and equity of those potential benefits; 3) whether and how clinician factors impact those potential benefits; and 4) identify how to deliver CDST and related interventions effectively and equitably.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily Treichler, PhD
- Phone Number: (858) 552-8585
- Email: Emily.Treichler@va.gov
Study Locations
-
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California
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San Diego, California, United States, 92161-0002
- VA San Diego Healthcare System, San Diego, CA
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Principal Investigator:
- Emily Treichler, PhD
-
Contact:
- Emily Treichler, PhD
- Phone Number: 858-552-8585
- Email: Emily.Treichler@va.gov
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West Los Angeles, California, United States, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Contact:
- Sonya Gabrielian, MD
- Phone Number: 213-503-5519
- Email: Sonya.Gabrielian@va.gov
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New Mexico
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Albuquerque, New Mexico, United States, 87108-5153
- New Mexico VA Health Care System, Albuquerque, NM
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Contact:
- Kate Belon, PhD
- Phone Number: 5943 505-265-1711
- Email: Katherine.Belon@va.gov
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be a Veteran currently receiving PRRC, MHICM and/or BHIP services at VA San Diego, Los Angeles, or Albuquerque (e.g., seen in the clinic in the past month or based on clinic criteria)
- meet SAMHSA criteria of serious mental illness; i.e., "having (within the past year) a diagnosable mental, behavior, or emotional disorder that causes serious functional impairment that substantially interferes with or limits one or more major life activities," based on chart review and clinician consultation if needed
- Be age 18 or above
- Be fluent and literate in English.
- Agree to have a subset of VA mental health treatment appointments audiotaped
Exclusion Criteria:
- primary substance use or organic neurological disorder diagnosis determined by chart review
- are determined by clinician and/or study staff to be at significant risk of exacerbation of symptoms, suicidal ideation, or other risk due to study participation
- have a history and/or current risk of violence that clinicians and/or study staff determine to be too high risk to manage effectively in the study setting (e.g., poses a risk to Veterans or study staff).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Collaborative Decision Skills Training
Collaborative Decision Skills Training (CDST) is the intervention group (experimental arm).
|
An ten-session group-based skills training intervention that focuses on treatment-related decision-making in order to facilitate improved engagement in decision-making processes.
CDST teaches assertiveness skills, problem solving, goal planning, and conflict negotiation, within the context of treatment planning and decision-making.
Each session is 60 minutes long.
Other Names:
|
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Active Comparator: Leveling Up
Leveling Up is the active control arm.
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An ten-session group intervention that focuses on psychoeducation, befriending, and Veteran to Veteran support.
Each session is 60 minutes long.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shared Decision-Making Coding System
Time Frame: Baseline to 3-month follow-up
|
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers.
The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives.
Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference).
Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
|
Baseline to 3-month follow-up
|
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Shared Decision-Making Coding System
Time Frame: Baseline to 6-month follow-up
|
The Shared Decision-Making Coding System (SDM-CS) is a validated method of coding collaborative behaviors during treatment decision-making among patients with SMI and their providers.
The SDM-CDS codes 9 elements of the decision process including goal setting, exploration of patient preference, and treatment alternatives.
Coding for this measure is completed by recording frequency of specific interactions (e.g., the patient states a preference).
Scores range from 0-18, where higher scores are better (indicating more collaborative behaviors).
|
Baseline to 6-month follow-up
|
|
Consumer-Created Opportunities for Active Involvement Coding System
Time Frame: Baseline to 3-month follow-up
|
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship.
This measure codes behaviors, so the minimum score is 0, and it has no maximum.
Higher scores indicate more collaborative behaviors initiated by the consumer.
|
Baseline to 3-month follow-up
|
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Consumer-Created Opportunities for Active Involvement Coding System
Time Frame: Baseline to 6-month follow-up
|
A validated measure for adults with SMI that codes presence of consumer driven collaborative behaviors, including sharing opinions about treatment effectiveness, making requests, and reflecting on the therapeutic relationship.
This measure codes behaviors, so the minimum score is 0, and it has no maximum.
Higher scores indicate more collaborative behaviors initiated by the consumer.
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Baseline to 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Singh O'Brien Level of Engagement Scale
Time Frame: Baseline to 3-month follow-up
|
A 14-item clinician-rated measure using a 4-point Likert scale.
Scores range from 0-42, where higher scores indicate more service engagement.
|
Baseline to 3-month follow-up
|
|
Singh O'Brien Level of Engagement Scale
Time Frame: Baseline to 6-month follow-up
|
A 14-item clinician-rated measure using a 4-point Likert scale.
Scores range from 0-42, where higher scores indicate more service engagement.
|
Baseline to 6-month follow-up
|
|
Client Satisfaction Questionnaire
Time Frame: Baseline to 3-month follow-up
|
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32.
Higher scores indicate higher levels of satisfaction.
|
Baseline to 3-month follow-up
|
|
Client Satisfaction Questionnaire
Time Frame: Baseline to 6-month follow-up
|
An 8-item self-report measure of client satisfaction, with scores ranging from 8-32.
Higher scores indicate higher levels of satisfaction.
|
Baseline to 6-month follow-up
|
|
Canadian Occupational Performance Measure- Performance subscale
Time Frame: Baseline to 3-month follow-up
|
A short interview-based measure that assesses goal attainment in a range of functional areas.
In this study, the investigators will use the performance subscale.
The performance subscale is rated between 1-10, where higher scores indicate better performance.
|
Baseline to 3-month follow-up
|
|
Canadian Occupational Performance Measure- Performance subscale
Time Frame: Baseline to 6-month follow-up
|
A short interview-based measure that assesses goal attainment in a range of functional areas.
In this study, the investigators will use the performance subscale.
The performance subscale is rated between 1-10, where higher scores indicate better performance.
|
Baseline to 6-month follow-up
|
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Goal Attainment Scaling
Time Frame: Baseline to 3-month follow-up
|
An algorithm that identifies goals and goal attainment.
Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.
|
Baseline to 3-month follow-up
|
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Goal Attainment Scaling
Time Frame: Baseline to 6-month follow-up
|
An algorithm that identifies goals and goal attainment.
Scores range from -2 to +2, with 0 meaning that the expected outcome was achieved, while lower scores mean that less favorable outcomes occurred, and higher scores mean that better than expected outcomes occurred.
|
Baseline to 6-month follow-up
|
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Maryland Assessment of Recovery in Serious Mental Illness
Time Frame: Baseline to 3-month follow-up
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A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope.
Scores range from 25-125, with higher scores indicating higher levels of personal recovery.
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Baseline to 3-month follow-up
|
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Maryland Assessment of Recovery in Serious Mental Illness
Time Frame: Baseline to 6-month follow-up
|
A 25-item self-report measure that assesses personal alignment with six primary domains of recovery: self-direction or empowerment, holistic, nonlinear, strengths based, responsibility, and hope.
Scores range from 25-125, with higher scores indicating higher levels of personal recovery.
|
Baseline to 6-month follow-up
|
|
Personal and Social Performance scale
Time Frame: Baseline to 3-month follow-up
|
A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.
Scores range from 1-100, with higher scores indicating better social functioning.
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Baseline to 3-month follow-up
|
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Personal and Social Performance scale
Time Frame: Baseline to 6-month follow-up
|
A clinician-reported scale of patient ability in four areas: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior.
Scores range from 1-100, with higher scores indicating better social functioning.
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Baseline to 6-month follow-up
|
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Shared Decision Making Questionnaire for Mental Health
Time Frame: Baseline to 3-month follow-up
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9 item measure of involvement in treatment decisions.
Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
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Baseline to 3-month follow-up
|
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Shared Decision Making Questionnaire for Mental Health
Time Frame: Baseline to 6-month follow-up
|
9 item measure of involvement in treatment decisions.
Scores range from 0-45, with higher scores indicating high levels of involvement in treatment decisions.
|
Baseline to 6-month follow-up
|
|
Problem-Solving Decision-Making Scale for Mental Health
Time Frame: Baseline to 3-month follow-up
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Self-report about preferences for involvement in treatment decision-making based on three brief vignettes.
There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.
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Baseline to 3-month follow-up
|
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Problem-Solving Decision-Making Scale for Mental Health
Time Frame: Baseline to 6-month follow-up
|
Self-report about preferences for involvement in treatment decision-making based on three brief vignettes.
There are 18 items and a total score range from 18-90, with lower scores indicating preference for paternalistic (provider-determined) decision-making, higher scores indicating preference for self-determination in treatment decisions, and middle scores indicating preference for provider-self collaboration.
|
Baseline to 6-month follow-up
|
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Patient Perceived Involved in Care Scale
Time Frame: Baseline to 3-month follow-up
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13 item self report measure.
Scores range 0-13, with higher scores indicating higher perceived involvement in care.
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Baseline to 3-month follow-up
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Patient Perceived Involved in Care Scale
Time Frame: Baseline to 6-month follow-up
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13 item self report measure.
Scores range 0-13, with higher scores indicating higher perceived involvement in care.
|
Baseline to 6-month follow-up
|
|
Empowerment Scale
Time Frame: Baseline to 3-month follow-up
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28 item self-report measure.
Scores range from 0-112, where lower scores indicate more empowerment.
Developed specifically for people with serious mental illness.
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Baseline to 3-month follow-up
|
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Empowerment Scale
Time Frame: Baseline to 6-month follow-up
|
28 item self-report measure.
Scores range from 0-112, where lower scores indicate more empowerment.
Developed specifically for people with serious mental illness.
|
Baseline to 6-month follow-up
|
|
Behaviour and Symptom Identification Scale (BASIS)
Time Frame: Baseline to 3-month follow-up
|
24 item self-report scale of broad mental health symptom severity, where higher scores indicate higher symptom severity.
Total scores and subscales are based on weighted means of items, ranging of 0-4.
|
Baseline to 3-month follow-up
|
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Behaviour and Symptom Identification Scale (BASIS)
Time Frame: Baseline to 6-month follow-up
|
24 item self-report scale of broad mental health symptom severity, where higher scores indicate higher symptom severity.
Total scores and subscales are based on weighted means of items, ranging of 0-4.
|
Baseline to 6-month follow-up
|
|
Clinical Global Impression
Time Frame: Baseline to 3-month follow-up
|
Two item clinician rating of global illness severity.
Higher scores indicate greater overall severity.
Items are scored separately and both are on a 1-7 likert scale.
|
Baseline to 3-month follow-up
|
|
Clinical Global Impression
Time Frame: Baseline to 6-month follow-up
|
Two item clinician rating of global illness severity.
Higher scores indicate greater overall severity.
Items are scored separately and both are on a 1-7 likert scale.
|
Baseline to 6-month follow-up
|
|
Brief Inventory of Psychosocial Functioning
Time Frame: Baseline to 3-month follow-up
|
7 item self report measure of social functioning.
Developed specifically for adults with serious mental illness.
Total scores result in a 0-100 range where higher scores indicate higher functional impairment.
|
Baseline to 3-month follow-up
|
|
Brief Inventory of Psychosocial Functioning
Time Frame: Baseline to 6-month follow-up
|
7 item self report measure of social functioning.
Developed specifically for adults with serious mental illness.
Total scores result in a 0-100 range where higher scores indicate higher functional impairment.
|
Baseline to 6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scale to Assess Therapeutic Relationship (patient and clinician versions)
Time Frame: Baseline to 3-month follow-up
|
12 item measure to assess therapeutic alliance.
One is patient-completed and one is clinician-completed.
Total scores range from 0-48, where higher scores indicate higher therapeutic alliance.
|
Baseline to 3-month follow-up
|
|
Scale to Assess Therapeutic Relationship (patient and clinician versions)
Time Frame: Baseline to 6-month follow-up
|
12 item measure to assess therapeutic alliance.
One is patient-completed and one is clinician-completed.
Total scores range from 0-48, where higher scores indicate higher therapeutic alliance.
|
Baseline to 6-month follow-up
|
|
Maslach Burnout Inventory
Time Frame: Every three months for 2.5 year clinical trial duration
|
22 item measure of burnout.
Includes three subscales, emotional exhaustion (9 items, total score ranging 0-54), depersonalization (5 items, total score ranging 0 - 30), and personal accomplishment (8 items, total score ranging from 0 -48).
Total score therefore ranges from 0- 132.
Higher scores indicate more burnout.
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Every three months for 2.5 year clinical trial duration
|
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General Self-Efficacy Scale
Time Frame: Every three months for 2.5 year clinical trial duration
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10 item self report measure.
Scores range from 10-40 with higher scores indicate higher self efficacy.
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Every three months for 2.5 year clinical trial duration
|
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Recovery Knowledge Inventory
Time Frame: Every three months for 2.5 year clinical trial duration
|
20 item clinical report measure.
Scores range from 20-100 where higher scores indicate greater knowledge of recovery and stronger recovery orientation.
|
Every three months for 2.5 year clinical trial duration
|
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Task and Relational Climate Scale
Time Frame: Every three months for 2.5 year clinical trial duration
|
six item self report scale of work climate related to two subconstructs (tasks and relationships with colleagues).
Scoring ranges from 0-15 on each subscale and 0-30 overall, where higher scores indicate more positive climate.
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Every three months for 2.5 year clinical trial duration
|
|
Collaborative Decision Making Attitudes Measure
Time Frame: Every three months for 2.5 year clinical trial duration
|
8 item clinician report measure.
Scores range from 0-40 where higher scores indicate greater use of collaborative decision-making and greater alignment with collaborative decision-making as a clinical practice.
|
Every three months for 2.5 year clinical trial duration
|
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Work satisfaction
Time Frame: Every three months for 2.5 year clinical trial duration
|
Single 10-point item (Overall, how satisfied are you with your current job?")
|
Every three months for 2.5 year clinical trial duration
|
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Perceived Cultural Competency
Time Frame: Baseline to 3-month follow-up
|
9 item patient completed scale.
Total scores range from 9-63 where higher scores indicate better cultural competency experiences with clinicians.
|
Baseline to 3-month follow-up
|
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Perceived Cultural Competency
Time Frame: Baseline to 6-month follow-up
|
9 item patient completed scale.
Total scores range from 9-63 where higher scores indicate better cultural competency experiences with clinicians.
|
Baseline to 6-month follow-up
|
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Qualitative interviews
Time Frame: Baseline to six month follow up
|
Veteran semi-structured interviews focused on constructs aligned with quantitative outcomes including involvement in decision-making, treatment engagement, motivation, and satisfaction, and attainment of recovery goals.
These interviews capture both primary, secondary, and pre-specified outcomes and will be triangulated with quantitative measures during the mixed methods integration process.
|
Baseline to six month follow up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emily Treichler, PhD, VA San Diego Healthcare System, San Diego, CA
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5052-R
- RX005052 (Other Grant/Funding Number: VA RR&D)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Data will be shared with researchers and consumer advocates who provide a rationale and methodological sound plan for their use of the data. Acceptable uses include meta-analysis and mega-analysis, among other uses. Data sets provided to requesters will include data necessary for the requester's stated purpose, as long as the requester's purpose does not violate participant privacy, research ethics, or similar procedures.
Requests for access must be made in writing including an explicit assurance that the recipient will not attempt to identify or re-identify any individual. Requests must be signed by a requester currently residing in the United States. The request must reference the publication or other source motivating the request along with the detailed purpose for the request. Requests should be made to the corresponding author or the principal investigator, but can be made to the Associate Chief of Staff for Research.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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