Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504149
Status:
WITHDRAWN
Last Update Posted:
2022-12-06
First Post:
2020-07-29
Brief Title:
Shared Decision Making for PTSD in Primary Care
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient Readiness for Improvement Through Motivation Engagement and Decision-making for PTSD CDA 18-186
Status:
WITHDRAWN
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Findings from Aims 1 and 2 clarified that any future trial should involve provider- or clinic-level randomization not patient-level randomization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIMED-PTSD
Brief Summary:
PTSD is one of the most common mental health conditions affecting Veterans and is associated with significant burden Highly effective treatments exist for PTSD evidence-based psychotherapies but very few Veterans receive them Although VA has trained over 8500 providers in evidence-based psychotherapies for PTSD over the past 10 years only 6 of the 650000 VHA patients with PTSD receive an evidence-based psychotherapy It is critical to connect Veterans with the most effective PTSD treatments and done so in a way that is Veteran-centered Shared decision making is a patient-centered approach to choosing healthcare treatment options It has been shown to increase patients motivation for treatment and ability to stay in treatment long enough to get benefit It has also been shown to help providers align their practice with evidence-based guidelines This proposal will refine and pilot test a shared decision making intervention for PTSD to be used in VA primary care clinics where the vast majority of Veterans with PTSD are treated
Detailed Description:
Background Over 1 million Veterans have PTSD and most 80 or more do not receive first-line treatments evidence-based psychotherapies despite significant VA investment to increase access to these treatments Clinicians often struggle to engage Veterans in evidence-based psychotherapies because they can be emotionally challenging treatments Engagement could be catalyzed by mental health providers integrated into primary care ie VAs Primary Care-Mental Health Integration or PC-MHI to maximize the reach of engagement efforts beyond specialty PTSD settings Shared decision making a process by which the patient and provider discuss treatment options weigh benefits and risks and select a treatment that meets the patients needs addresses known patient and provider barriers to evidence-based psychotherapies including knowledge self-efficacy and trust However no study has examined shared decision making for PTSD in primary care The proposal will address this knowledge gap by developing and refining a shared decision making intervention for PTSD Patient Readiness for Improvement through Motivation Engagement and Decision-making PRIMED using input from Veterans with diverse perspectives PC-MHI providers and VA operational partners to optimize integration of shared decision making into clinical care The investigators will collect acceptability and feasibility data to support an application for a future effectiveness-implementation trial
SignificanceImpact Dr Chens proposed research addresses three HSRD and VA priorities 1 increase engagement and retention of Veterans in evidence-based PTSD treatments 2 advance health services research methods specifically implementation science and user-centered design which focuses on thorough integration of Veteran and frontline provider input and 3 support suicide prevention efforts through effective treatment of PTSD a major risk factor for suicide
Innovation The proposed project will promote significant change in current VA clinical practice PC-MHI providers typically refer out patients with PTSD and defer discussions about treatment options to specialty providers This proposal will help PC-MHI providers use a formal engagement strategy shared decision making to improve patients knowledge of first-line PTSD treatments and to build motivation for care
Specific Aims 1 Refine PRIMED using user-centered design methods and diverse Veterans perspectives 2 Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize integration into clinical workflow and achieve satisfactory acceptability and feasibility across a range of settings 3 Conduct a small randomized pilot trial N40 of PRIMED vs usual care in two VA PC-MHI clinics to assess the feasibility of study procedures which will inform a future larger trial
Methodology In Aim 1 Dr Chen will conduct qualitative interviews using user-centered design methods with 25 VA PC-MHI patients with PTSD oversampling women veterans and racialethnic minority veterans to refine the PRIMED intervention protocol In Aim 2 Dr Chen will use rapid iterative beta-testing with approximately 20 patients to optimize the acceptability and feasibility of delivering PRIMED in the clinical setting and its integration into clinical workflow across varied settings small rural clinics and large urban clinics In Aim 3 Dr Chen will conduct a pilot randomized feasibility trial N40 to assess the feasibility of recruiting and randomizing Veterans and measuring treatment engagement and clinical outcomes
Next StepsImplementation The research and training activities will prepare the nominee to conduct a multi-site hybrid type 1 effectiveness-implementation trial to test the effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to assess implementation barriers and facilitators Future work to move this research into practice would involve collaborating with operational partners to improve VA SAIL performance measures in mental health which are weighted to encourage evidence-based psychotherapies
SignificanceImpact Dr Chens proposed research addresses three HSRD and VA priorities 1 increase engagement and retention of Veterans in evidence-based PTSD treatments 2 advance health services research methods specifically implementation science and user-centered design which focuses on thorough integration of Veteran and frontline provider input and 3 support suicide prevention efforts through effective treatment of PTSD a major risk factor for suicide
Innovation The proposed project will promote significant change in current VA clinical practice PC-MHI providers typically refer out patients with PTSD and defer discussions about treatment options to specialty providers This proposal will help PC-MHI providers use a formal engagement strategy shared decision making to improve patients knowledge of first-line PTSD treatments and to build motivation for care
Specific Aims 1 Refine PRIMED using user-centered design methods and diverse Veterans perspectives 2 Beta test PRIMED in one rural and one urban PC-MHI clinic to optimize integration into clinical workflow and achieve satisfactory acceptability and feasibility across a range of settings 3 Conduct a small randomized pilot trial N40 of PRIMED vs usual care in two VA PC-MHI clinics to assess the feasibility of study procedures which will inform a future larger trial
Methodology In Aim 1 Dr Chen will conduct qualitative interviews using user-centered design methods with 25 VA PC-MHI patients with PTSD oversampling women veterans and racialethnic minority veterans to refine the PRIMED intervention protocol In Aim 2 Dr Chen will use rapid iterative beta-testing with approximately 20 patients to optimize the acceptability and feasibility of delivering PRIMED in the clinical setting and its integration into clinical workflow across varied settings small rural clinics and large urban clinics In Aim 3 Dr Chen will conduct a pilot randomized feasibility trial N40 to assess the feasibility of recruiting and randomizing Veterans and measuring treatment engagement and clinical outcomes
Next StepsImplementation The research and training activities will prepare the nominee to conduct a multi-site hybrid type 1 effectiveness-implementation trial to test the effectiveness of PRIMED for increasing receipt of first-line PTSD treatments and to begin to assess implementation barriers and facilitators Future work to move this research into practice would involve collaborating with operational partners to improve VA SAIL performance measures in mental health which are weighted to encourage evidence-based psychotherapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None