Toolkit for Optimal Recovery After Orthopedic Injury

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).

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.

Population: The number of participants analyzed in this outcome reflects the number of participants (out of the total enrolled and randomized) who made it to the posttest assessment and could complete this questionnaire (i.e. did not drop out and were not lost to followup in the time since randomization and enrollment).

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

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).

Population: Participants in both the active treatment arm (TOR) and control group (MEUC) are reported together, since regardless of study arm, all participants completed the same baseline, posttest, and followup questionnaires at the timepoints. This is appropriate for the feasibility benchmark of data collection; we are only assessing the feasibility of collecting these questionnaires for this outcome across the study as a whole, and not comparing the feasibility between the arms.

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.

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)

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).

Population: This measure refers to the total number of sessions that were analyzed for this outcome. The overall number of units analyzed that is reported here reflects the total number of sessions delivered over the course of the study, that were then scored by therapists. The overall number of participants analyzed is the number of participants who were randomized to the TOR arm of the study, and received the intervention (which included the sessions (units) that were analyzed for this outcome).

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).

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).

Population: Total number of participants enrolled per site are listed here. The adverse events reported below for each site are for TOR and MEUC together, since regardless of study arm, adverse events were reported and logged for all arms together at each site. This is appropriate because we are not comparing adverse events in any way between the arms.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived appropriateness (relevance, compatibility) of the study for their patient population, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

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)

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)

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).

Population: The total number of participants randomized in the TOR arm is listed here. The completed data on adverse events reported below is only for TOR. 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, which is part of the TOR arm only.

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).

Population: The data reported are for TOR and MEUC together, since regardless of study arm, any use of narcotic rescue analgesics were reported and logged for all arms together. 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.

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).

Population: The data reported are for TOR and MEUC together, since regardless of study arm, any use of non-narcotic rescue analgesics were reported and logged for all arms together. 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.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff feasibility of study implementation in their clinic. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived appropriateness. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived cost-benefit measure for the clinic. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff perceived cost-benefit measure for the patient. This is in regards to the intervention and the study procedures as a whole, and is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff ease of referrals, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of obtaining the data on staff satisfaction, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

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.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the feasibility of implementing the study, as perceived by surgeons and staff, in regards to the intervention and the study procedures as a whole; it is not related to the actual treatment arms themselves.

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).

Population: Total number of participants enrolled per site listed here. Deviations reported for each site are for TOR and MEUC together, since regardless of study arm, deviations were reported and logged for all arms together 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.

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).

Population: Total number of participants enrolled per site listed here. Deviations reported for each site are for TOR and MEUC together, since regardless of study arm, deviations were reported and logged for all arms together 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.

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)

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)

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)

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).

Population: The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to referrals, from surgeons and staff, to the study overall, and it is not related to the actual treatment arms themselves. This is appropriate for the feasibility benchmark assessing whether referrals for this trial (and thus our intervention) are feasible for surgeons and clinic staff to complete.

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)

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)

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the acceptability of surgeons and staff, in regards to the intervention and the study procedures (cost-benefit to the clinic) as a whole, and it is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who referred patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived acceptability of surgeons and staff, in regards to the intervention and cost-benefit to the patient, and it is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who were involved with referring patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the perceived acceptability of surgeons and staff, in regards to the intervention and the study procedures as a whole (referral process), and it is not related to the actual treatment arms themselves.

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.

Population: This population is orthopedic surgeons and staff who were involved with referring patients to the study. The active treatment arm (TOR) and control group (MEUC) are not relevant to this outcome/analysis population, since this measure refers to the satisfaction of surgeons and staff, in regards to the intervention and the study procedures as a whole, and it is not related to the actual treatment arms themselves.

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 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)

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)

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).

Population: 16 clinicians/therapists were randomly selected to review fidelity checks. Since study clinicians were only used in the intervention arm (TOR), study arm, i.e. TOR vs. MEUC, is not an applicable breakdown for this outcome, as those in the MEUC arm would not have received the intervention, i.e. the sessions that were assessed in this fidelity check.

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)

Population: The overall number of participants analyzed reflects all participants who were analyzed at the first timepoint/row below (i.e. baseline). The actual numbers analyzed, reported at each timepoint/row below, reflects that some were lost to follow-up or had dropped out of the study by the different time points.

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)

Population: The overall number of participants analyzed reflects all participants who were analyzed at the first timepoint/row below (i.e. baseline). The actual numbers analyzed, reported at each timepoint/row below, reflects that some were lost to follow-up or had dropped out of the study by the different time points.