Functional and Occupational Rehabilitation of Troops (FORT)

January 15, 2026 updated by: The University of Texas Health Science Center at San Antonio

An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel

The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Katherine A Comtois, PhD, MPH
  • Phone Number: 206-744-1752
  • Email: kcomtois@uw.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Active duty military personnel diagnosed with chronic musculoskeletal pain.

Description

Inclusion Criteria:

"patient referred to functional restoration program by provider"

Exclusion Criteria:

"patient not referred to functional restoration program by provider"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Treatment as Usual
At their assigned step, each site will receive 6 months of Treatment as Usual (TAU). This step will include patients seen at each of the six study sites who participate in the current interdisciplinary chronic pain management program that is available at those sites prior to the initiation of the FORT Implementation Facilitation.
Implementation Facilitation + FORT
At their assigned step, each site will receive 6 months of External Facilitation kicked off with an initial site visit. At the site visit, the external facilitators will meet with key stakeholders, clinic providers, and staff. Together, the team will review the FORT Implementation Site-Assessment Survey as a baseline assessment of implementation as well as the FORT Program Implementation Planning Guide. The team will work together to develop a site-specific implementation blueprint called the Site Action Plan.
FORT Functional Restoration
During the subsequent 6 months, the site action plan will be executed, monitored, and refined to meet the implementation goals. As per Implementation Facilitation, the facilitator will apply many different implementation strategies to support the uptake of FORT, tailoring strategies to the needs of the site and the stakeholders engaged in the process. Implementation Facilitation will be conducted virtually through a combination of scheduled video teleconferences or phone calls. Regular implementation team meetings will be scheduled to support the implementation process

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Impact Score (PIS)
Time Frame: Baseline to 13 months
The Pain Impact Score (PIS) is based on the Defense and Veterans Pain Rating Scale (DVPRS), which measures 7-day average pain intensity (0-10 scale) and adaptive PROMIS pain interference and physical function using numeric, color, facial, and word descriptors and is validated. PROMIS T-scores are converted to compute the PIS, ranging from 8-50 with a higher score indicating greater pain.
Baseline to 13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001264
  • W81XWH-22-2-0041 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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