Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans

Post-traumatic Stress Disorder Clinical Trial

Official title:

Increasing Engagement in Evidence-Based PTSD Therapy for Primary Care Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984515
• Other study ID #: RRP 13-204
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 10, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to implement an evidence-based Referral Management System that will address patient and system-level barriers to the uptake of evidence-based psychotherapy for PTSD by Veterans Affairs primary care patients.

Description:

Within the Veteran's Health Administration (VHA), primary care (PC) patients with PTSD have low rates of engagement in evidence-based psychotherapy (EBP) for PTSD. Low engagement rates are due to a variety of patient-level (e.g., belief that treatment will not be helpful, stigma) and system-level barriers (e.g., lack of tracking of referral process, knowledge gaps on how to manage PTSD). We propose to conduct a pilot hybrid effectiveness- implementation study to implement an evidence-based Referral Management System (RMS) that will address patient and system-level barriers to the uptake of EBP for PTSD by VHA primary care patients. RMS will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me"). This CBT intervention has been previously found to be effective for increasing treatment engagement with Veterans with PTSD. Depending on Veteran preference, it will be delivered by the PC-MHI provider within the PC clinic or a Behavioral Health Lab (BHL) care manager by phone. RMS will be initiated by PACT staff and will address system-level barriers by having a BHL technician track the progress of RMS referrals and contact Veterans who have not followed thought on their chosen referral options. PACT staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD. Our aims, implementation strategy, data collection, and analyses will be guided by established strategies. The Consolidated Framework for Implementation Research (CFIR) will identify organization variables. RE-AIM will investigate program uptake and patient/ system-level impact. An Implementation Mapping approach will guide our implementation strategy. We propose to conduct this study in 3 phases. Phase 1 includes interviews with PC and MH leadership about the relevance of CFIR constructs to RMS implementation and a meeting with PACT staff to train them on RMS and gather their input on how RMS should be adapted to their clinic. A PC medical provider will serve as a clinical champion who is knowledgeable, communicative, and a leader in promoting RMS among his/her peers. Phase 2 consists of implementing RMS for 6 months in one Syracuse PC clinic and then measuring RE-AIM outcomes. Some RE-AIM outcomes compared participants who received RMS to those who did not receive RMS in a historical control group. Phase 3 involves meeting with PACT and MH Leadership and PACT staff to share a formal report of study results and gather information about potential barriers and facilitators to long-term maintenance and future expansion of RMS within the CFIR framework. An expert national stakeholder panel will also be convened to guide development of a SDP that will investigate multi-VISN implementation.

Our long-term aim of this line of research is to increase implementation of evidence-based psychotherapy for PTSD by getting more primary care patients with PTSD to engage in treatment.

Our Specific Aims for this Rapid Response Project are to:

1. Assess and improve the feasibility of implementing RMS in PC-MHI/PACT settings

1A. Diagnose organizational and staff-level barriers and facilitators to implementing RMS.

1B. Adapt RMS for the local context based on information gathered about barriers and facilitators.

2. Evaluate initial impact of implementing RMS in PC-MHI/PACT settings. Assess impact of RMS on RE-AIM measures of Reach, Efficacy/Effectiveness, Adoption, Implementation and Maintenance 3. Refine implementation strategy based on study findings for planned efforts to spread RMS to additional VISNs in a QUERI Phase 2 Service-Directed Project (SDP) to follow.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Team Red primary care patients,

• have a score of at least 44 on PCL-S and

• able to give informed consent.

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Referral Management System
Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., "talking about past trauma will be too difficult for me"). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD.

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in Evidence-based Psychotherapy for PTSD	Engagement will be assessed by how many patients attend at least 2 sessions of an evidence-based psychotherapy for PTSD and how many complete treatment. Completion is defined as 8 sessions.	From initiation of the Referral Management System to 6 months after initiation	No
Secondary	PTSD Checklist-Specific	Measures the 17 symptoms of PTSD according to the DSM-IV. Scale for each item ranges from 1-5. Total scale score ranges from 17-85. 17 represents no PTSD symptoms and 85 represented the most severe PTSD symptoms.	Referral Management Initiation, 1 month post initiation, 3 months post initiation	No
Secondary	Patient Health Questionnaire-9 Item	9 symptoms of depression are measured on a 0-3 scale. Total scale range is 0-27, with higher scores indicating worse depression.	Referral Management Initiation, 1 month post initiation, 3 months post initiation	No