Toolkit for Optimal Recovery After Orthopedic Injury

Study Overview
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Brief Summary
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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
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Study Rationale: The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in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). Hypothesis: We expect that TOR will meet all a priori set benchmarks. Secondary Objectives: There will be 27 secondary outcomes. All will be reported separately for each site (see below). 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 will 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.

Official Title
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Toolkit for Optimal Recovery After Orthopedic Injury; A Multisite Feasibility Study to Prevent Persistent Pain and Disability

Conditions
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Acute Orthopedic Injury

Intervention / Treatment
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* Behavioral: Toolkit for Optimal Recovery after Orthopedic Injury
* Other: Minimally Enhanced Usual Care (MEUC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toolkit for Optimal Recovery after Orthopedic Injury - Active<br>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<br>* 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.<br>|
| Active Comparator: Minimally Enhanced Usual Care (MEUC) - Control<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment among all patients | We will report number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants. | throughout the study completion, on average of 2 years | 
| Appropriateness rated by participants randomized to TOR, assessed by the Credibility and Expectancy Scale | Rate of participant's expectations and believed credibility for program, with range 3 to 27 and higher ratings indicating more belief that the program is logical and will help with the intended outcome. | Baseline | 
| Feasibility of data collection | We will report number of patients who complete assessments at each time-point. | throughout the study completion, on average of 3 years | 
| 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. Items are summed to generate a total score; scores range from 3 to 12, with higher values indicating higher satisfaction. | Post-Test | 
| Acceptability of TOR (attendance for patients randomized to TOR) | We will report number of sessions attended for participants enrolled to TOR. | throughout the study completion, on average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of randomization/adherence to assigned arm for all enrolled patients all enrolled patients | We will report number of participants who are randomized within one arm and complete post-test. | throughout the study completion, on average of 3 years | 
| Orthopedic staff feasibility of referral | We will report number of surgeons who make at least 5 referrals per site. We will keep track of the referring source and report number of referrals made by each surgeon. | throughout the study completion, on average of 3 years | 
| Fidelity to study procedures | We will report number of protocol deviations per site among all enrolled patients. | throughout the study completion, on average of 3 years | 
| Adherence to TOR homework | We will report number of homework logs that are returned with 4 out of 7 days of practice among patients randomized to TOR. | throughout the study completion, on average of 3 years | 
| Acceptability as rated by therapist | We will report number of participants who score over 7 out of 10 on the therapist rating of participation quality in each session among patients randomized to TOR. | throughout the study completion, on average of 3 years | 
| Perceived acceptability for those who completed the satisfaction measures | We will report number of surgeons and staff who score over 7 on satisfaction measure, among completers. | throughout the study completion, on average of 3 years | 
| Perceived acceptability of staff regarding ease of referral | We will report number of surgeons and staff who score over 7 on ease of referral measure, among completers. | throughout the study completion, on average of 3 years | 
| Perceived acceptability of staff regarding cost-benefit | We will report number of surgeons and staff who score over 7 on cost-benefit measure, among completers. | throughout the study completion, on average of 3 years | 
| Feasibility of study implementation as perceived by study staff | We will report number of surgeons and staff who score over 7 on Feasibility of study implementation as perceived by study staff who completed measures. | throughout the study completion, on average of 3 years | 
| Appropriateness as perceived by study staff | We will report number of surgeons and staff who score over 7 on Appropriateness as perceived by study staff who completed measures. | throughout the study completion, on average of 3 years | 
| Feasibility of collecting Orthopedic staff satisfaction measures | We will report number of surgeons and study staff who complete the measure. | throughout the study completion, on average of 3 years | 
| Feasibility of obtaining data on Orthopedic staff perceived ease of referrals | We will report number of surgeons and study staff who complete the measure. | throughout the study completion, on average of 3 years | 
| Feasibility of obtaining data on Orthopedic staff perceived cost-benefit | We will report number of surgeons and study staff who complete the measure. | throughout the study completion, on average of 3 years | 
| Feasibility of collecting data on feasibility of study implementation | We will report number of surgeons and staff who complete the data. | End of study | 
| Feasibility of collecting appropriateness measures | We will report number of surgeons and staff who complete appropriateness measure. | throughout the study completion, on average of 3 years | 
| Numerical Rating Scale | Rate of participant's pain at rest and with activity using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 
| Physical function self-report | The PROMIS Physical Function (v1.0 8b) assesses one's ability to carry out activities that require physical actions ranging from self-care to social and work. Items ranging from 1-4, and total scores ranging from 8-40, with a higher score reflect greater physical function. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 
| Physical function performance-based | The Timed 10 Meter Walk Test will be used for those with lower extremity injury or body injury, which measures how fast one can walk 10 meters, which is a valid indicator for evaluating the physical function. The Grip Test using a dynamometer will be used for those with upper extremity injuries and measures the amount of muscular strength or the maximum force/tension generated by one's forearm muscles, as a method for assessing physical function. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 
| Coping and emotional function | The Center for Epidemiologic Study of Depression (CES-D), a 20-item measure assesses depressive symptomatology; scores range from 0-60 and higher scores indicate greater depressive symptomatology. The 17-item PTSD Checklist civilian measure assesses post-traumatic stress; scores range from 17-85 with higher scores indicating greater post-traumatic stress. The Pain Catastrophizing Scale (PCS), a 13-item measure assesses hopelessness, helplessness and rumination about pain, with items ranging from 0-4 and total scores ranging from 0-52, with higher scores indicating higher levels of pain catastrophizing. The Pain Anxiety Scale, short form (PASS-20) assesses cognitive and somatic symptoms of anxiety, items range from 0-100 and higher scores indicating greater pain anxiety. The Measure of Current Status (MOCS-A) assesses ability to engage in healthy coping skills, with items ranging from 0-4, total score ranging from 0-52, and higher scores reflecting more usage of general coping skills. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 
| Feasibility of data collection for performance based measures of physical function (walk/grip test) at each of the 3 time points | We will report number of enrolled participants who will have complete for performance based measures of physical function (Walk/Grip test). | Duration of project, (two years) | 
| Feasibility of data collection of rescue analgesics (non-narcotic) | We will report number of participants with complete data on rescue analgesics (non-narcotic) among enrolled patients with orthopedic injuries via self-report log. | Duration of project, (two years) | 
| Feasibility of data collection of rescue analgesics (narcotic) | We will report number of participants with complete data on rescue analgesics (narcotic) among enrolled patients with orthopedic injuries via self-report log. | Duration of project, (two years) | 
| Adverse events | We will report number of adverse events among all enrolled patients with orthopedic injuries. | Duration of project, (two years) | 
| Feasibility of data collection of adverse events | We will report number of participants with complete data on adverse events among enrolled patients with orthopedic injuries. | Duration of project, (two years) | 
| Therapist adherence/fidelity to session | We will report number of participants who present ≥75 adherence (checklist and audio recordings). | Duration of project, (two years) | 
| Within group change in rescue analgesics (non-narcotic) | Self-report of past-week rescue analgesics use collected before each intervention session. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 
| Within group change in narcotic analgesics | Self-report of past-week narcotic rescue analgesics use collected before each intervention session. | Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Mind-Body, Physical Function, Disability, Psychosocial