Toolkit for Optimal Recovery After Orthopedic Injury

NCT04973696 | Completed Results

• 1 other identifier: 2020P000095
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mind-Body; Pain; Physical Function; Disability; Psychosocial

Outcome Measures

Primary Outcomes (5)

• Feasibility of Recruitment Among All Patients

  We will report number of participants who consented to participate out of those eligible, evaluated at the end of study. This number is not the same as the number who were actually enrolled and randomized in the trial (195).

  At the end of the entire enrollment period of the study, which was about 1 year and 10 months.

• Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale

  A measure of participant's expectations and believed credibility for program (i.e. appropriateness), as assessed by the Credibility and Expectancy Scale. This scale has a range of 3 to 27 points, with higher ratings indicating more belief that the program is logical and will help with the intended outcome. This measure was the count of patients who scored above or below the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Credibility and Expectancy Scale

  Baseline

• Feasibility of Data Collection

  This outcome will assess the feasibility of collecting the data used to assess and compare the TOR intervention to MEUC (usual care); it is not looking at the data itself or comparing two arms, but just the feasibility of collecting it. To assess this feasibility marker of our intervention, we will report the number of patients who complete their study assessments, for both TOR and MEUC together, at all of their required timepoints in the study.

  On the participant level, data was collected over the course of 4 months (baseline through followup). Counts reported here and described above were summed at the final end of all study activities (a total duration of 1 year 10 months).

• Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only)

  Participant's satisfaction with treatment received after completion of TOR was assessed using the Client Satisfaction Questionnaire. In this questionnaire, items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. This measure is the count of participants in TOR who scored above the scale's theoretical midpoint (i.e. the midpoint is not based on the collected data) on the Client Satisfaction Questionnaire.

  Assessed at Post-Test, which was approximately 4 weeks after a participant's enrollment in the study and baseline assessment.

• Acceptability of TOR (Attendance for Patients Randomized to TOR)

  We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.

  On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts of attendance were summed at the end of the study (~1 year and 10 months).

Secondary Outcomes (36)

• Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients

  Assessed the counts for the study as a whole at the end of study completion, which was about 1 year and 10 months. On the participant level, the time from randomization to posttest took place over an average of 4 weeks.

• Orthopedic Staff Feasibility of Referral

  On the staff member level, the data for this outcome was collected over the course of the entire intervention/study (about 1 year and 7 months total from the start of referrals and participant enrollment in the study).

• Fidelity to Study Procedures (Minor Deviations)

  On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).

• Fidelity to Study Procedures (Major Deviations)

  On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).

• Adherence to TOR Homework

  On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts were then summed at the end of the study (~1 year and 10 months).

Study Arms (2)

Toolkit for Optimal Recovery after Orthopedic Injury - Active

EXPERIMENTAL

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.

Behavioral: Toolkit for Optimal Recovery after Orthopedic Injury

Minimally Enhanced Usual Care (MEUC) - Control

ACTIVE COMPARATOR

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.

Other: Minimally Enhanced Usual Care (MEUC)

Interventions

Toolkit for Optimal Recovery after Orthopedic Injury BEHAVIORAL

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.

Toolkit for Optimal Recovery after Orthopedic Injury - Active

Minimally Enhanced Usual Care (MEUC) OTHER

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.

Minimally Enhanced Usual Care (MEUC) - Control

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients in the Level 1 Trauma Center of one of the 4 sites, age 18 years or older
• Sustained one more more acute orthopedic injuries (e.g., fracture, dislocation, rupture) approximately 1-2 months earlier (acute phase)
• Score ≥20 on the Pain Catastrophizing Scale (PCS) or ≥40 on the Short Form Pain Anxiety Scale (PASS-20)
• Willing to participate and comply with the requirements of the study protocol, including randomization, questionnaire completion, and potential home practice and weekly sessions.
• No psychotropics for at least 2 weeks prior to initiation of treatment or stable for \>6 weeks and willing to maintain a stable dose
• Cleared by orthopedic surgeon for activities using the injured limb within the next 4 weeks
• Able to meaningfully participate (e.g., English speaking and comprehension, stable living situation as determined by the medical staff at each site)
• A score of 8/10 or more on the Short Portable Mental Status Questionnaire ONLY IF a participant is 65 or older, or if a participant's cognitive abilities are unclear to research staff

You may not qualify if:

• Serious comorbidity expected to worsen in the next 3 months (e.g., malignancy)
• Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
• Current suicidal ideation
• Other unmanaged serious non-orthopedic injuries that occurred alongside the orthopedic injury (i.e., TBI, ruptured internal organs, etc.)
• Practice of meditation, or other mind body techniques that elicit the RR, for at least 45 total minutes a week each week over the last 3 months
• Currently in litigation or under Workman's Comp
• Surgery complications (e.g., uncontrolled infection, need for repeat surgery)
• Self-reported pregnancy

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Texas at Austin: collaborator
• University of Kentucky: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02140, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Ana-Maria Vranceanu
• Organization: Center for Health Outcomes and Interdisciplinary Research, Massachusetts General Hospital

avranceanu@mgh.harvard.edu

617-724-4977

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research assistants who assess outcomes and collect data after randomization, orthopedic surgeons, and statistician will be blinded. The study clinicians will be unblinded. The research assistant who enrolls participants and performs activities before randomization will be unblinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: September 21, 2021
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Locations

US (1)