TOP Implementation Project

NCT02737098 | Completed Results

• 2 other identifiers: QUX 16-005QUE 15-282
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 6

Brief Summary

The Veterans Health Administration (VHA) provides care to 3.3 million Veterans living in rural areas, comprising 36% of all VHA enrollees. In 1995, VHA began expanding its system of Community Based Outpatient Clinics (CBOCs) in order to improve access for the geographically dispersed Veteran population. There are now approximately 900 CBOCs delivering a range of services to approximately 64% of VHA enrollees. While these CBOCs have dramatically improved access to first class primary care services, it has been more challenging to deliver specialty mental health care to rural Veterans. Evidence based specialty mental care practices developed for large VA Medical Centers are often not feasible to deploy in small CBOCs and thus not accessible to rural Veterans. Telemedicine Outreach for PTSD (TOP) is a technology-facilitated virtual care clinical intervention that is designed to enhance access to evidence based psychotherapy and pharmacotherapy for posttraumatic stress disorder (PTSD). The TOP clinical intervention is delivered by a virtual care team comprising a CBOC provider, and a telephone care manager, telepsychologist and telepsychiatrist located at the VAMC. The goal of this implementation project is to support the national deployment of the TOP intervention and evaluate its clinical effectiveness in routine care. The specific aims are to compare the effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes. The standard VA implementation strategy will follow standard procedures for deploy clinical practices in the VA include disseminating support materials, providing technical assistance and transfer funds to hire clinical personnel. The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. The project will compare the standard VA implementation strategy to the enhanced implementation strategy. All VAMCs will receive the enhanced implementation strategy if they need it, but the time period during which they will receive the enhanced implementation strategy will be randomized. This will allow us to determine whether more patients are reached by the TOP intervention during standard implementation compared to enhanced implementation. Data will be collected from patient survey and chart review for all patients sampled for the evaluation. Participating patients will complete a baseline survey and 3 follow-up surveys. The reach implementation outcome measure will be specified as the proportion of sampled patients who received the TOP intervention. PTSD outcomes will be specified as a continuous change in patient self-reported symptom severity between baseline and follow-up. Perceived access will be measured using items specifically developed for the project.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; virtual care; implementation; telepsychiatry; telepsychology

Outcome Measures

Primary Outcomes (1)

• Reach: the Proportion of Sampled Patients Who Received the Core Element of the TOP Intervention

  The reach implementation outcome measure will be specified as the proportion of sampled patients who received the core element of the TOP intervention (documentation in the electronic health record of a care manager encounter).

  31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)

Secondary Outcomes (4)

• PTSD Symptom Severity

  31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)

• Perceived Travel Burden: Degree to Which Sampled Patients Report That Traveling Interferes With Getting Services.

  31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)

• Perceived Wait Time: Degree to Which Sampled Patients Report That Appointment Wait Time Interferes With Getting Services.

  31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)

• Perceived Trust: Degree to Which Sampled Patients Report That Lack of Trust in Providers Interferes With Getting Services.

  31 months (Step 1 - 9 months; Gap 1 - 2 months; Step 2 - 9 months; Gap 2 - 2 months; Step 3 - 9 months)

Study Arms (2)

Standard Implementation

ACTIVE COMPARATOR

Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.

Other: Standard Implementation Strategy

Enhanced Implementation Strategy

ACTIVE COMPARATOR

The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.

Other: Enhanced Implementation Strategy

Interventions

Enhanced Implementation Strategy OTHER

The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.

Enhanced Implementation Strategy

Standard Implementation Strategy OTHER

Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.

Standard Implementation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PTSD Diagnosis
• Positive PTSD Screen

You may not qualify if:

• No specialty mental health encounters at the VAMC

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (6)

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2208, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (2)

• Fortney JC, Rajan S, Chen JA, Campbell SB, Nolan JP, Wong E, Sayre G, Petrova V, Simons CE, Reisinger HS, Schnurr PP. A mixed-methods evaluation of why an implementation trial failed to engage veterans with posttraumatic stress disorder in trauma-focused psychotherapy. J Trauma Stress. 2023 Aug;36(4):762-771. doi: 10.1002/jts.22946. Epub 2023 Jun 27.

  PMID: 37370238 DERIVED

• Fortney JC, Rajan S, Reisinger HS, Moeckli J, Nolan JP, Wong ES, Rise P, Petrova VV, Sayre GG, Pyne JM, Grubaugh A, Simsek-Duran F, Grubbs KM, Morland LA, Felker B, Schnurr PP. Deploying a telemedicine collaborative care intervention for posttraumatic stress disorder in the U.S. Department of Veterans Affairs: A stepped wedge evaluation of an adaptive implementation strategy. Gen Hosp Psychiatry. 2022 Jul-Aug;77:109-117. doi: 10.1016/j.genhosppsych.2022.03.009. Epub 2022 Mar 26.

  PMID: 35596963 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Results Point of Contact

• Title: John Fortney
• Organization: VA

john.fortney@va.gov

206.764.2821

Study Officials

• John C. Fortney, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2020
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)