Toolkit for Optimal Recovery After Orthopedic Injury; A Multisite Feasibility Study to Prevent Persistent Pain and Disability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment Among All Patients
研究概览
简要总结
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.
详细描述
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The care of patients with acute orthopedic injuries follows an outdated biomedical model, and consists primarily of surgical interventions and pain medications, despite strong evidence for the pivotal role of psychosocial factor in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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research assistants who assess outcomes and collect data after randomization, orthopedic surgeons, and statistician will be blinded.
The study clinicians will be unblinded. The research assistant who enrolls participants and performs activities before randomization will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Feasibility of Recruitment Among All Patients
时间窗: At the end of the entire enrollment period of the study, which was about 1 year and 10 months.
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).
Appropriateness of Treatment Program, Rated by Participants Randomized to TOR and Assessed by the Credibility and Expectancy Scale
时间窗: Baseline
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
Feasibility of Data Collection
时间窗: 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).
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.
Acceptability of Treatment (Satisfaction) Assessed With the Client Satisfaction Questionnaire (Patients Randomized to TOR Only)
时间窗: Assessed at Post-Test, which was approximately 4 weeks after a participant's enrollment in the study and baseline assessment.
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.
Acceptability of TOR (Attendance for Patients Randomized to TOR)
时间窗: 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).
We will the report total number of patients in the TOR intervention who attend all four sessions that are part of their intervention.
次要结局
- Within Group Use of Rescue Analgesics (Narcotic)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Feasibility of Randomization/Adherence to Assigned Arm, for All Enrolled Patients(Assessed the counts for the study as a whole at the end of study completion, which was about 1 year and 10 months. On the participant level, the time from randomization to posttest took place over an average of 4 weeks.)
- Orthopedic Staff Feasibility of Referral(On the staff member level, the data for this outcome was collected over the course of the entire intervention/study (about 1 year and 7 months total from the start of referrals and participant enrollment in the study).)
- Fidelity to Study Procedures (Minor Deviations)(On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).)
- Fidelity to Study Procedures (Major Deviations)(On the participant level, the data for this outcome was collected over the course of the intervention as well as the through the followup time point, a total of 4 months. Counts of deviations were summed at the end of the study (~1 year and 10 months).)
- Adherence to TOR Homework(On the participant level, the data for this outcome was collected over the course of the intervention and its sessions (4 weeks). Counts were then summed at the end of the study (~1 year and 10 months).)
- Acceptability as Rated by Therapist(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(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(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(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(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(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(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(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(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(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(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(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(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(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Numerical Rating Scale (Pain During Activity), Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Therapist Adherence/Fidelity to Session(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).)
- Short Musculoskeletal Function Assessment (SMFA), Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Center for Epidemiologic Study of Depression (CES-D), Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- PTSD Checklist- Civilian Measure (PCL-C), Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Pain Catastrophizing Scale (PCS), Change Between Time Points.(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Pain Anxiety Scale, Short Form (PASS-20), Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Measure of Current Status (MOCS-A), Change Between Time Points.(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Cognitive and Affective Mindfulness Scale- Revised (CAMS-R), Change Between Time Points.(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- Feasibility of Data Collection of Rescue Analgesics (Non-narcotic)(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)(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)(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(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).)
- Within-group Use of Rescue Analgesics (Non-narcotic)(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
- 2-tailed Pearson Correlation (TOR and MEUC)(Baseline (Week 0), Post-Test (Week 4))
- Physical Function Self-report, Change Between Time Points(Baseline (0 Weeks), Post-Test (4 Weeks), Follow-up (3 Months))
研究者
Ana-Maria Vranceanu, PhD
Principal Investigator
Massachusetts General Hospital