An interventional study of Toolkit for Optimal Recovery after Orthopedic Injury and Minimally Enhanced Usual Care (MEUC) in Acute Orthopedic Injury, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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.
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The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 195 is above the median of 70 across 1,904 interventional studies indexed under Pain.
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Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
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
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)
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.
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.
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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients
We will report number of participants who are randomized within one arm and complete post-test.
Time frame: 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
We will report the number of surgeons and staff who make at least 5 referrals across all four sites, to assess whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete. Referrals could come from providers at any point over the course of the intervention/study.
Time frame: 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)
We will report number of minor deviations per each separate, site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting minor deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
Time frame: 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)
We will report number of major deviations per each separate site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting major deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
Time frame: 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
The number of participants who returned at least 1 out of 3 homework logs (1 log was given per week), that have 4 out of 7 days of practice reported on those logs.
Time frame: 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).
Acceptability as Rated by Therapist
Assessed using a therapist scale rating patient participation quality in each session. We will report the number of TOR sessions that scored over 7 (out of 10 possible points). There were 304 total TOR sessions delivered over the course of the study, and 294 sessions received a score over 7.
Time frame: On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts that met our criteria noted in the description were then summed at the end of the study (~1 year and 10 months).
Perceived Satisfaction of Staff
We will report the number of surgeons and staff who score over 7 on the satisfaction question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Ease of Referral
We will report number of surgeons and staff who score over 7 on the ease of referral question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Patient
We will report the number of surgeons and staff who score over 7 on the cost-benefit (patient) question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic
We will report the number of surgeons and staff who score over 7 on the cost-benefit (clinic) question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Study Implementation as Perceived by Study Staff
We will report the number of surgeons and staff who score over 7 on the feasibility of study implementation question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Appropriateness as Perceived by Study Staff
We will report the number of surgeons and staff who score over 7 on the appropriateness question that was part of a study feedback survey. This question assessed the the perceived appropriateness (relevance, compatibility) of the study for their patient population.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Satisfaction
We will report the number of surgeons and study staff who complete the study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals
We will report the number of surgeons and staff who complete the ease of referral question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure
We will report the number of surgeons and staff who complete the perceived cost-benefit (patient) measure question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure
We will report the number of surgeons and staff who complete the perceived cost-benefit (clinic) measure question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation
We will report the number of surgeons and staff who complete the feasibility question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness
We will report the number of surgeons and staff who complete the perceived appropriateness measure question that was part of a study feedback survey.
Time frame: On the staff member level, the data for this outcome was collected in a one-time survey at the end of the intervention and recruitment in their clinics, administered at about 1 year and 7 months from the start of the study.
Numerical Rating Scale (Pain at Rest), Change Between Time Points
Rating of participant's pain at rest using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Numerical Rating Scale (Pain During Activity), Change Between Time Points
Rate of participant's pain with activity using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points
The Short Musculoskeletal Function Assessment (SMFA) assesses one's self-report physical function and the extent to which a participant is bothered by their functioning. Scores range from 46 to 230. Higher scores represent greater dysfunction or bother. Means reported reflect the Mean Difference between the time points noted in the row title. A decrease in score between baseline and posttest or baseline and followup (i.e. a more negative difference, or larger negative difference, as reported here) reflects improvements in physical function.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points
The 17-item PTSD Checklist civilian measure assesses post-traumatic stress; scores range from 17-85 with higher scores indicating greater post-traumatic stress. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Catastrophizing Scale (PCS), Change Between Time Points.
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Measure of Current Status (MOCS-A), Change Between Time Points.
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 reflect greater self-perceived current state. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points.
The Measure of Current Status (MOCS-A) assesses mindfulness, with total score ranging from 12-48. Higher scores indicate greater mindfulness. Means reported reflect the Mean Difference between the timepoints noted in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Feasibility of Data Collection of Rescue Analgesics (Non-narcotic)
We will report number of participants with complete data on non-narcotic rescue analgesics (non-narcotic) among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting non-narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
Time frame: 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 complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Rescue Analgesics (Narcotic)
We will report number of participants with complete data on narcotic rescue analgesics among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
Time frame: 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 complete data were summed at the end of the study (~1 year and 10 months).
Adverse Events (Serious and Non-serious)
We will report number of adverse events (serious and non-serious) per each separate site among all enrolled patients with orthopedic injuries (both TOR and MEUC combined at each site). This is appropriate to report the arms together because we are not comparing adverse events in any way between the arms. Definition of an adverse event in this study: throughout the study, subjects were monitored for the occurrence of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment was not considered an event.
Time frame: 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 complete data were summed at the end of the study (~1 year and 10 months).
Feasibility of Data Collection of Adverse Events
We will report number of participants with completed data on their adverse events, among enrolled patients with orthopedic injuries in the TOR arm. Data will be reported by study clinicians, for all sites and both arms combined. This is appropriate for the feasibility benchmark of collecting the adverse event data, since we are interested in whether it is feasible for our treatment/study intervention, which is part of the TOR arm only.
Time frame: On the participant level, 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 complete data were summed at the end of the study (~1 year and 10 months).
Therapist Adherence/Fidelity to Session
We will report the number of adherence/fidelity "points" that therapists achieved from reviewers during their fidelity checks, over the course of the study. These fidelity checks were done by assessing a checklist review of audio recordings of the sessions, and were completed by 2 raters, for 16 different TOR therapists.
Time frame: On the fidelity reviewer level, the data for this outcome was collected over the course of the intervention as the sessions were delivered by therapists (4 weeks of delivery). Reviews/points were then summed at end of the study (~1 year and 10 months).
Within-group Use of Rescue Analgesics (Non-narcotic)
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
Within Group Use of Rescue Analgesics (Narcotic)
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
2-tailed Pearson Correlation (TOR and MEUC)
We assessed the correlation between change scores in the Short Musculoskeletal Function Assessment (SMFA) and change scores on the following mechanistic targets of the TOR intervention: Center for Epidemiologic Study of Depression (CES-D), Posttraumatic Stress Disorder Checklist (PCL), Pain Catastrophizing Scale (PCS), Pain Anxiety Scale Short Form (PASS), Measures of Current Status (MOCS), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Change scores reflected the difference in score between baseline (week 0) and post-test (week 4). Possible correlations range from 0-1; the closer a correlation score is to 1, the more correlated (associated, related) the two measures being compared are. This means that the closer a correlation in change scores is to 1, the more related a change in SMFA is to a change in the named mechanistic target of the intervention.
Time frame: Baseline (Week 0), Post-Test (Week 4)
Physical Function Self-report, Change Between Time Points
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 activities to work. Raw scores are converted to T scores, which are standardized scores based on the average in the population (a score of 50 would indicate matching the average score in the reference, general population. T scores range from 8-40, with a higher score reflecting greater physical function and ability to carry out the activity. Means reported reflect the Mean Difference between the time points in the row titles listed. For the differences reported, a bigger difference thus reflects a greater improvement in physical function.
Time frame: Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months)
The two arms for this study and participant flow are listed below. As stated in the Protocol Section, several secondary outcomes will assess whether the intervention (TOR) tested in this study is feasible, acceptable, and satisfactory, from the point of view of the clinic staff and surgeons in the orthopedic clinics that are the sites of recruitment for study participants. Since they were not actually enrolled in the study, these clinic staff and surgeons are not included in participant flow.
| Milestone | Toolkit for Optimal Recovery After Orthopedic Injury (TOR) - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Started | 97 | 98 |
| Completed | 74 | 81 |
| Not completed | 23 | 17 |
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).
| Participants | All Participants (TOR and MEUC) |
|---|---|
| Feasibility of Recruitment Among All Patients | 210 |
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
| Participants | TOR Only |
|---|---|
| Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale | 66 |
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.
| Participants | All Participants (TOR and MEUC) |
|---|---|
| Feasibility of Data Collection | 154 |
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.
| Participants | TOR Only |
|---|---|
| Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only) | 75 |
We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.
| Participants | TOR Only |
|---|---|
| Acceptability of TOR (Attendance for Patients Randomized to TOR) | 71 |
We will report number of participants who are randomized within one arm and complete post-test.
| Participants | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients | 76 | 93 |
We will report the number of surgeons and staff who make at least 5 referrals across all four sites, to assess whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete. Referrals could come from providers at any point over the course of the intervention/study.
| Participants | Referring Staff (All Four Sites Combined) |
|---|---|
| Orthopedic Staff Feasibility of Referral | 25 |
We will report number of minor deviations per each separate, site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting minor deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
| minor protocol deviations | Massachusetts General Hospital | Dell Medical School | Vanderbilt University Medical Center | University of Kentucky College of Medicine |
|---|---|---|---|---|
| Fidelity to Study Procedures (Minor Deviations) | 7 | 1 | 4 | 3 |
We will report number of major deviations per each separate site among all enrolled patients (both TOR and MEUC combined at each site). This is appropriate for the fidelity benchmark of collecting major deviations; we are only assessing our ability to adhere to the study procedures consistently and not drift in administration (i.e. fidelity), and we are not comparing fidelity in any way between the arms.
| major protocol deviations | Massachusetts General Hospital | Dell Medical School | Vanderbilt University Medical Center | University of Kentucky College of Medicine |
|---|---|---|---|---|
| Fidelity to Study Procedures (Major Deviations) | 1 | 0 | 0 | 0 |
The number of participants who returned at least 1 out of 3 homework logs (1 log was given per week), that have 4 out of 7 days of practice reported on those logs.
| Participants | TOR Only |
|---|---|
| Adherence to TOR Homework | 74 |
Assessed using a therapist scale rating patient participation quality in each session. We will report the number of TOR sessions that scored over 7 (out of 10 possible points). There were 304 total TOR sessions delivered over the course of the study, and 294 sessions received a score over 7.
| count of sessions | Fidelity Check - TOR Sessions |
|---|---|
| Acceptability as Rated by Therapist | 294 |
We will report the number of surgeons and staff who score over 7 on the satisfaction question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Perceived Satisfaction of Staff | 15 |
We will report number of surgeons and staff who score over 7 on the ease of referral question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Perceived Acceptability of Staff Regarding Ease of Referral | 22 |
We will report the number of surgeons and staff who score over 7 on the cost-benefit (patient) question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Perceived Acceptability of Staff Regarding Cost-benefit for the Patient | 15 |
We will report the number of surgeons and staff who score over 7 on the cost-benefit (clinic) question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Perceived Acceptability of Staff Regarding Cost-benefit for the Clinic | 15 |
We will report the number of surgeons and staff who score over 7 on the feasibility of study implementation question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Study Implementation as Perceived by Study Staff | 15 |
We will report the number of surgeons and staff who score over 7 on the appropriateness question that was part of a study feedback survey. This question assessed the the perceived appropriateness (relevance, compatibility) of the study for their patient population.
| Participants | Staff Rating |
|---|---|
| Appropriateness as Perceived by Study Staff | 14 |
We will report the number of surgeons and study staff who complete the study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Satisfaction | 20 |
We will report the number of surgeons and staff who complete the ease of referral question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Perceived Ease of Referrals | 22 |
We will report the number of surgeons and staff who complete the perceived cost-benefit (patient) measure question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Patient) Measure | 19 |
We will report the number of surgeons and staff who complete the perceived cost-benefit (clinic) measure question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Perceived Cost-benefit (Clinic) Measure | 21 |
We will report the number of surgeons and staff who complete the feasibility question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Feasibility of Study Implementation | 19 |
We will report the number of surgeons and staff who complete the perceived appropriateness measure question that was part of a study feedback survey.
| Participants | Staff Rating |
|---|---|
| Feasibility of Obtaining Data on Orthopedic Staff Perceived Appropriateness | 16 |
Rating of participant's pain at rest using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to Post-Treatment | -1.7 (-2.1 to -1.2) | -0.5 (-0.9 to -0.1) |
| Baseline to Follow-Up | -2.0 (-2.5 to -1.5) | -1.0 (-1.5 to -0.5) |
Rate of participant's pain with activity using the Numerical Rating Scale, a Likert scale with 0 being no pain and 10 being the worst possible pain. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to Post-Treatment | -1.7 (-2.1 to -1.2) | -1.0 (-1.4 to -0.6) |
| Baseline to Follow-Up | -2.4 (-3.0 to -1.8) | -1.6 (-2.1 to -1.0) |
The Short Musculoskeletal Function Assessment (SMFA) assesses one's self-report physical function and the extent to which a participant is bothered by their functioning. Scores range from 46 to 230. Higher scores represent greater dysfunction or bother. Means reported reflect the Mean Difference between the time points noted in the row title. A decrease in score between baseline and posttest or baseline and followup (i.e. a more negative difference, or larger negative difference, as reported here) reflects improvements in physical function.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Posttest minus baseline mean score | -16 (-19 to -13) | -8 (-11 to -6) |
| Followup minus baseline mean score | -24 (-27 to -20) | -18 (-21 to -14) |
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | -9 (-11 to -7) | -3 (-5 to -1) |
| Baseline to follow-up | -10 (-12 to -7) | -4 (-7 to -2) |
The 17-item PTSD Checklist civilian measure assesses post-traumatic stress; scores range from 17-85 with higher scores indicating greater post-traumatic stress. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | -7 (-10 to -5) | -4 (-6 to -1) |
| Baseline to follow-up | -10 (-13 to -7) | -5 (-8 to -2) |
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | -14 (-16 to -12) | -6 (-8 to -4) |
| Baseline to follow-up | -15 (-18 to -12) | -8 (-10 to -5) |
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. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | -38 (-41 to -34) | -13 (-17 to -10) |
| Baseline to follow-up | -38 (-42 to -33) | -19 (-23 to -14) |
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 reflect greater self-perceived current state. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | 0.4 (0.2 to 0.5) | 0.01 (-0.1 to 0.2) |
| Baseline to follow-up | 0.4 (0.3 to 0.6) | 0.1 (-0.03 to 0.3) |
The Measure of Current Status (MOCS-A) assesses mindfulness, with total score ranging from 12-48. Higher scores indicate greater mindfulness. Means reported reflect the Mean Difference between the timepoints noted in the row title.
| score on a scale | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to post-test | 3 (2 to 4) | 0 (-1 to 1) |
| Baseline to follow-up | 3 (1 to 4) | 1 (-1 to 2) |
We will report number of participants with complete data on non-narcotic rescue analgesics (non-narcotic) among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting non-narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
| Participants | All Participants (TOR and MEUC) |
|---|---|
| Feasibility of Data Collection of Rescue Analgesics (Non-narcotic) | 155 |
We will report number of participants with complete data on narcotic rescue analgesics among all enrolled patients with orthopedic injuries, via self-report log. This is appropriate for the feasibility benchmark of collecting narcotic rescue analgesics; we are only assessing our ability to feasibly collect this information, and we are not comparing feasibility in any way between the arms.
| Participants | All Participants (TOR and MEUC) |
|---|---|
| Feasibility of Data Collection of Rescue Analgesics (Narcotic) | 155 |
We will report number of adverse events (serious and non-serious) per each separate site among all enrolled patients with orthopedic injuries (both TOR and MEUC combined at each site). This is appropriate to report the arms together because we are not comparing adverse events in any way between the arms. Definition of an adverse event in this study: throughout the study, subjects were monitored for the occurrence of events defined as any undesirable experience or unanticipated risk. Lack of effect of treatment was not considered an event.
| adverse events | Massachusetts General Hospital | Dell Medical School | Vanderbilt University Medical Center | University of Kentucky College of Medicine |
|---|---|---|---|---|
| Adverse Events | 0 | 2 | 0 | 1 |
| Serious Adverse Events | 1 | 0 | 1 | 1 |
We will report number of participants with completed data on their adverse events, among enrolled patients with orthopedic injuries in the TOR arm. Data will be reported by study clinicians, for all sites and both arms combined. This is appropriate for the feasibility benchmark of collecting the adverse event data, since we are interested in whether it is feasible for our treatment/study intervention, which is part of the TOR arm only.
| participants with completed data | TOR Only |
|---|---|
| Feasibility of Data Collection of Adverse Events | 97 |
We will report the number of adherence/fidelity "points" that therapists achieved from reviewers during their fidelity checks, over the course of the study. These fidelity checks were done by assessing a checklist review of audio recordings of the sessions, and were completed by 2 raters, for 16 different TOR therapists.
| Points | Fidelity Check |
|---|---|
| Therapist Adherence/Fidelity to Session | 6829 |
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
| percentage | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline non-narcotic use (percentage) | 22.9 | 64.3 |
| Post-test non-narcotic use (percentage) | 9.2 | 60.6 |
| Follow-up non-narcotic use (percentage) | 9.5 | 61.3 |
Self-report of past-week rescue analgesics use was collected from participants at each assessment timepoint and is reported here for each timepoint; timepoint is indicated in the row title.
| percentage | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline narcotic use (percentage) | 22.9 | 33.7 |
| Post-test narcotic use (percentage) | 9.2 | 19.1 |
| Follow-up narcotic use (percentage) | 9.5 | 13.8 |
We assessed the correlation between change scores in the Short Musculoskeletal Function Assessment (SMFA) and change scores on the following mechanistic targets of the TOR intervention: Center for Epidemiologic Study of Depression (CES-D), Posttraumatic Stress Disorder Checklist (PCL), Pain Catastrophizing Scale (PCS), Pain Anxiety Scale Short Form (PASS), Measures of Current Status (MOCS), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Change scores reflected the difference in score between baseline (week 0) and post-test (week 4). Possible correlations range from 0-1; the closer a correlation score is to 1, the more correlated (associated, related) the two measures being compared are. This means that the closer a correlation in change scores is to 1, the more related a change in SMFA is to a change in the named mechanistic target of the intervention.
| 2-tailed Pearson Correlation (r) | TOR - Active Treatment Group | MEUC - Control Group |
|---|---|---|
| SMFA Change-CES-D Change-Correlation | 0.6 (0.428 to 0.724) | 0.7 (0.539 to 0.769) |
| SMFA Change-PCL Change Correlation | 0.4 (0.244 to 0.609) | 0.5 (0.364 to 0.662) |
| SMFA Change-PCS Change Correlation | 0.3 (0.044 to 0.465) | 0.4 (0.208 to 0.553) |
| SMFA Change-PASS Change Correlation | 0.3 (0.072 to 0.486) | 0.5 (0.313 to 0.626) |
| SMFA Change-MOCS Change Correlation | -0.2 (-0.407 to 0.027) | -0.3 (-0.473 to -0.098) |
| SMFA Change-CAMS-R Change Correlation | -0.2 (-0.389 to 0.049) | -0.3 (-0.489 to -0.118) |
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 activities to work. Raw scores are converted to T scores, which are standardized scores based on the average in the population (a score of 50 would indicate matching the average score in the reference, general population. T scores range from 8-40, with a higher score reflecting greater physical function and ability to carry out the activity. Means reported reflect the Mean Difference between the time points in the row titles listed. For the differences reported, a bigger difference thus reflects a greater improvement in physical function.
| T score | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control |
|---|---|---|
| Baseline to Post-Treatment | 6 (5 to 8) | 4 (3 to 6) |
| Baseline to Follow-Up | 12 (10 to 14) | 11 (9 to 12) |
Collected over Adverse event data was collected for each participant, if needed, over the duration of their time in the study (baseline/enrollment through followup, over a 3 month time period).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Massachusetts General Hospital | 0/66 (0%) | 1/66 (1.5%) | 0/66 (0%) |
| Dell Medical School | 0/48 (0%) | 0/48 (0%) | 2/48 (4.2%) |
| Vanderbilt University Medical Center | 0/30 (0%) | 1/30 (3.3%) | 0/30 (0%) |
| University of Kentucky College of Medicine | 0/51 (0%) | 1/51 (2%) | 1/51 (2%) |
| Event | Massachusetts General Hospital | Dell Medical School | Vanderbilt University Medical Center | University of Kentucky College of Medicine |
|---|---|---|---|---|
| Pneumonia and hospitalizationInfections and infestations | 0/66 | 0/48 | 1/30 | 0/51 |
| Diagnosis of ankle septic arthritis and hospitalizationInfections and infestations | 0/66 | 0/48 | 0/30 | 1/51 |
| Suicide attempt and subsequent hospitalizationPsychiatric disorders | 1/66 | 0/48 | 0/30 | 0/51 |
| Event | Massachusetts General Hospital | Dell Medical School | Vanderbilt University Medical Center | University of Kentucky College of Medicine |
|---|---|---|---|---|
| Fall onto ankleMusculoskeletal and connective tissue disorders | 0/66 | 1/48 | 0/30 | 0/51 |
| New onset of jaw painMusculoskeletal and connective tissue disorders | 0/66 | 1/48 | 0/30 | 0/51 |
| Increased pain severity with movementMusculoskeletal and connective tissue disorders | 0/66 | 0/48 | 0/30 | 1/51 |
Participants were individuals with recent orthopaedic injuries (1-2 months prior) with elevator pain anxiety and/or pain catastrophizing.
| Age, Continuous(years) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Mean | 43 ± 17 | 45 ± 16 | 44 ± 17 |
| Sex/Gender, Customized(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Man | 31 | 32 | 63 |
| Woman | 63 | 62 | 125 |
| Genderqueer/gender fluid/nonbinary | 3 | 3 | 6 |
| Prefer not to say | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Female | 65 | 66 | 131 |
| Male | 32 | 32 | 64 |
| Ethnicity (NIH/OMB)(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 13 | 27 |
| Not Hispanic or Latino | 80 | 83 | 163 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race (NIH/OMB)(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 4 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 8 | 15 |
| White | 76 | 73 | 149 |
| More than one race | 5 | 7 | 12 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Education(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Less than high school | 1 | 6 | 7 |
| Completed high school or GED | 20 | 26 | 46 |
| Some college/Associates degree | 29 | 23 | 52 |
| Completed 4 years of college | 30 | 19 | 49 |
| Graduate/professional degree | 15 | 23 | 38 |
| Choose Not to Answer | 2 | 1 | 3 |
| Employment(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Employed full-time | 48 | 49 | 97 |
| Employed part-time | 15 | 9 | 24 |
| Going to school full or part-time | 4 | 2 | 6 |
| Keeping House/Housemaker | 1 | 2 | 3 |
| Other | 3 | 7 | 10 |
| Retired | 10 | 8 | 18 |
| Unemployed | 15 | 16 | 31 |
| Choose Not to Answer | 1 | 5 | 6 |
| Income(Participants) | Toolkit for Optimal Recovery After Orthopedic Injury - Active | Minimally Enhanced Usual Care (MEUC) - Control | Total |
|---|---|---|---|
| Less than $10,000 | 9 | 17 | 26 |
| $10,000 to less than $15,000 | 5 | 6 | 11 |
| $15,000 to less than $20,000 | 4 | 0 | 4 |
| $20,000 to less than $25,000 | 9 | 3 | 12 |
| $25,000 to less than $35,000 | 10 | 7 | 17 |
| $35,000 to less than $50,000 | 14 | 11 | 25 |
| $50,000 to less than $75,000 | 6 | 12 | 18 |
| $75,000 or more | 25 | 28 | 53 |
| Choose Not to Answer | 15 | 14 | 29 |
1 further baseline measures are reported on the registry.
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Massachusetts General Hospital