Clinical trial NCT04973696: Toolkit for Optimal Recovery After Orthopedic Injury
Official title: Toolkit for Optimal Recovery After Orthopedic Injury; A Multisite Feasibility Study to Prevent Persistent Pain and Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Orthopedic Injury
Keywords: Mind-Body
Pain
Physical Function
Disability
Psychosocial
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Texas at Austin
name: University of Kentucky
name: Vanderbilt University Medical Center
First posted: 2021-07-22
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Study Rationale:

The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in transition to persistent pain and disability.

We developed the first mind-body program - The Toolkit for Optimal Recovery after orthopedic injury (TOR) - to prevent chronic pain and disability in at-risk patients with orthopedic injuries. TOR is based on the fear avoidance model and teaches skills (e.g., mindfulness and relaxation, adaptive thinking, acceptance) to help optimize recovery. Each TOR session is 45 minutes long, and there are 4 sessions delivered within a period of 4-5 weeks (TOR and control arm will be yoked for the timing of interventions).

Primary Objective The primary objective is to conduct a multi-site feasibility RCT of TOR versus MEUC control in order to determine whether the study methodology and TOR meet a priori set benchmarks necessary for the success of the subsequent efficacy trial. There are 5 primary outcomes: 1. Feasibility of recruitment (assessed by number of participants who agree to participate); 2. Appropriateness (assessed with the Credibility and Expectancy Scale); 3. Feasibility of data collection (self-report; assessed by number of participants who complete these measures at the 3 time points); 4. Treatment satisfaction (assessed with the Client Satisfaction Scale); and 5. Acceptability of TOR (adherence to sessions).

It should be noted that some of the feasibility outcomes/markers will be reported for both groups together (i.e. TOR and MEUC combined, for example the feasibility of data collection), but others were only collected and reported for the TOR group, because they were assessing the intervention specifically; the intervention was only administered in the TOR arm, and thus this outcome can only be reported for the TOR arm. Outcomes will clearly state which groups they are reported for, if results are combined, and rationale will be provided for this decision.

Hypothesis: We expect that TOR will meet all a priori set benchmarks.

Secondary Objectives:

There will be 27 secondary outcomes. Outcomes (both primary and secondary) will be reported for all sites combined, unless otherwise noted in an outcome description. Several secondary outcomes (which will be noted) will assess whether the intervention (TOR) tested in this study is feasible, acceptable, and satisfactory, from the point of view of the staff and surgeons in the orthopedic clinics (sites of recruitment for intervention participants). These feasibility secondary outcomes do not reflect the perspectives or numbers of the actual participants (180 planned) who were enrolled in the trial, but rather those of the staff and surgeons in the clinics where these participants are being treated for their orthopedic injury, and from which referrals for participation in the study came.

Study Design:

In the present study, 180 patients with acute orthopedic injuries from the Level I Trauma Centers at Massachusetts General Hospital (Boston, MA), Dell Medical School (Austin, TX), the University of Kentucky (Lexington, KY), and Vanderbilt University Medical Center (Nashville, TN) who are at risk for chronic pain and disability are planned to be enrolled. After consent and baseline assessments, participants will be randomly assigned to TOR or to a minimally enhanced usual care control (MEUC). Subjects in the TOR group undergo a 4-week session (\~45 minutes each), individual, live video, synchronous mind-body intervention. The MEUC group will receive a pamphlet containing brief summarized information that reflects the intervention topics (e.g., the trajectory of pain and recovery after orthopedic illness). In addition, participants in both groups will receive usual medical care as determined by the medical team. Participants in both groups will complete assessments at baseline, after the completion of TOR, and 3 months (from baseline) later.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Serious comorbidity expected to worsen in the next 3 months (e.g., malignancy)
2. Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
3. Current suicidal ideation
4. Other unmanaged serious non-orthopedic injuries that occurred alongside the orthopedic injury (i.e., TBI, ruptured internal organs, etc.)
5. 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
6. Currently in litigation or under Workman's Comp
7. Surgery complications (e.g., uncontrolled infection, need for repeat surgery)
8. Self-reported pregnancy

Primary outcomes:
measure: Feasibility of recruitment among all patients
timeFrame: throughout the study completion, on average of 2 years
measure: Appropriateness rated by participants randomized to TOR, assessed by the Credibility and Expectancy Scale
timeFrame: Baseline
measure: Feasibility of data collection
timeFrame: throughout the study completion, on average of 3 years
measure: Acceptability of treatment (satisfaction) assessed with the Client Satisfaction Questionnaire (patients randomized to TOR only)
timeFrame: Post-Test
measure: Acceptability of TOR (attendance for patients randomized to TOR)
timeFrame: throughout the study completion, on average of 3 years
Secondary outcomes:
measure: Feasibility of randomization/adherence to assigned arm for all enrolled patients all enrolled patients
timeFrame: throughout the study completion, on average of 3 years
measure: Orthopedic staff feasibility of referral
timeFrame: throughout the study completion, on average of 3 years
measure: Fidelity to study procedures
timeFrame: throughout the study completion, on average of 3 years
measure: Adherence to TOR homework
timeFrame: throughout the study completion, on average of 3 years
measure: Acceptability as rated by therapist
timeFrame: throughout the study completion, on average of 3 years
measure: Perceived acceptability for those who completed the satisfaction measures
timeFrame: throughout the study completion, on average of 3 years
measure: Perceived acceptability of staff regarding ease of referral
timeFrame: throughout the study completion, on average of 3 years
measure: Perceived acceptability of staff regarding cost-benefit
timeFrame: throughout the study completion, on average of 3 years
measure: Feasibility of study implementation as perceived by study staff
timeFrame: throughout the study completion, on average of 3 years
measure: Appropriateness as perceived by study staff
timeFrame: throughout the study completion, on average of 3 years
measure: Feasibility of collecting Orthopedic staff satisfaction measures
timeFrame: throughout the study completion, on average of 3 years
measure: Feasibility of obtaining data on Orthopedic staff perceived ease of referrals
timeFrame: throughout the study completion, on average of 3 years
measure: Feasibility of obtaining data on Orthopedic staff perceived cost-benefit
timeFrame: throughout the study completion, on average of 3 years
measure: Feasibility of collecting data on feasibility of study implementation
timeFrame: End of study
measure: Feasibility of collecting appropriateness measures
timeFrame: throughout the study completion, on average of 3 years
measure: Numerical Rating Scale
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
measure: Physical function self-report
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
measure: Physical function performance-based
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
measure: Coping and emotional function
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
measure: Feasibility of data collection for performance based measures of physical function (walk/grip test) at each of the 3 time points
timeFrame: Duration of project, (two years)
measure: Feasibility of data collection of rescue analgesics (non-narcotic)
timeFrame: Duration of project, (two years)
measure: Feasibility of data collection of rescue analgesics (narcotic)
timeFrame: Duration of project, (two years)
measure: Adverse events
timeFrame: Duration of project, (two years)
measure: Feasibility of data collection of adverse events
timeFrame: Duration of project, (two years)
measure: Therapist adherence/fidelity to session
timeFrame: Duration of project, (two years)
measure: Within group change in rescue analgesics (non-narcotic)
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
measure: Within group change in narcotic analgesics
timeFrame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ana-Maria Vranceanu, PhD
role: PRINCIPAL_INVESTIGATOR
References: