NCT02737098

TOP Implementation Project

Status unknown NA Last updated 23 June 2020

What this trial tests

NA trial testing Enhanced Implementation Strategy in Posttraumatic Stress Disorder in 600 participants. Status unknown.

Timeline

1 April 2016

Primary endpoint
31 July 2019

30 September 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	600
Start date	1 April 2016
Primary completion	31 July 2019
Estimated completion	30 September 2020
Sites	6 locations across United States

Drugs / interventions tested

• Enhanced Implementation Strategy
• Standard Implementation Strategy

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 99, any sex, with Posttraumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. Rural Veterans with posttraumatic stress disorder (PTSD) treated at CBOCs experience little to no improvement in their symptoms over time. A major contributor of poor PTSD outcomes is that trauma-focused evidence-based psychotherapy is not being provided to Veterans in the CBOC setting. Moreover, travel barriers prevent most rural Veterans from receiving trauma-focused evidence-based psychotherapy at large VHA Medical Centers (VAMC). 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. The VHA Office of Rural Health and Office of Connected Health and Telehealth Services intend to deploy the TOP intervention nationally. This project will lay the ground work for this national implementation initiative.

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 cost and effectiveness of alternative implementation strategies to promote uptake of TOP and assess impact on access and PTSD outcomes.

The project will be conducted at 6 VAMCs and affiliated CBOCs without on-site psychologists trained in trauma-focused evidence-based psychotherapy. The total anticipated sample size will be 600.

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 telephone care managers will coordinates care. The telepsychologists will deliver of trauma-focused evidence-based therapy. The telepsychiatrists will provide psychiatric consultation. 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. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs. 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, local staff will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart.

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. This design will also allow us to document improvements in perceived access and PTSD outcomes for patients at sites that successfully implement the TOP intervention. 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. Provider adoption will be assessed with qualitative interviews of all CBOC clinicians treating a sampled patient as well as members of the TOP intervention team. Costs - The investigators will measure the cost of both implementation strategies both prospectively and retrospectively. The investigators will collect data on implementation activities during both the standard VA and enhanced implementation strategies.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Fortney JC, Rajan S, Reisinger HS, Moeckli J, et al · · 2022 · cited 11× · PMID 35596963 · DOI 10.1016/j.genhosppsych.2022.03.009
2. Economic costs of implementing evidence-based telemedicine outreach for posttraumatic stress disorder in VA.
   Wong ES, Rajan S, Liu CF, Morland LA, et al · · 2022 · cited 4× · PMID 37091111 · DOI 10.1177/26334895221116771
3. "Voice of concern" for rural veterans with PTSD: Care managers' role engaging rural veterans in evidence-based therapies via telemedicine.
   Petrova VV, Simons C, Rajan S, Reisinger HS, et al · · 2025 · PMID 39977698 · DOI 10.1037/tra0001845