Toolkit for Optimal Recovery After Orthopedic Injury

Summary

This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. TOR is a 4-session program delivered via secure live video to patients at risk for chronic pain, 1-2 months after an orthopedic traumatic injury. The primary aim of this study is to determine whether the study methodology (i.e., implementation, randomization, procedures and assessment of outcome measures) and delivery of TOR meet a priori set benchmarks for feasibility, acceptability, and appropriateness, necessary for the success of the subsequent efficacy trial.

Conditions

• Acute Orthopedic Injury

Interventions

BEHAVIORAL

Toolkit for Optimal Recovery after Orthopedic Injury

The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team.

OTHER

Minimally Enhanced Usual Care (MEUC)

The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.

Sponsors & Collaborators

• University of Texas at Austin

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• Vanderbilt University Medical Center

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Ana-Maria Vranceanu, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-21

Primary Completion

2023-08-15

Completion

2023-08-15

Countries

• United States

Study Locations