NCT06898866

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

March 18, 2025

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Impact Score (PIS)

    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

Study Arms (3)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Active duty military personnel diagnosed with chronic musculoskeletal pain.

You may qualify if:

  • "patient referred to functional restoration program by provider"

You may not qualify if:

  • "patient not referred to functional restoration program by provider"

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Alan L Peterson, PhD

CONTACT

Katherine A Comtois, PhD, MPH

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 27, 2025

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

January 20, 2026

Record last verified: 2026-01