A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal Trauma
A Randomized Controlled Trial Testing a Skills-Based Program Called "A Toolkit for Optimal Recovery" Delivered Via Secure Live Video Compared to Standard Medical Care in Patients With Acute Musculoskeletal Injuries
1 other identifier
interventional
55
1 country
1
Brief Summary
The aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedAugust 17, 2018
August 1, 2018
3.1 years
December 3, 2017
August 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Feasibility of recruitment
We will report number of patients approached, number who agreed to participate/were screened, number of patients randomized
0 Weeks
Satisfaction with ToR
3 questions assessing satisfaction with the physical recovery, with the care delivered, and with the clinician.
4 weeks; 3 months
Acceptability
We will report number of patients who finished ToR and UC and completed post-test from those who started the study (were randomized); We will also report number of participants who provided 3 months follow up
4 weeks; 3 months
Feasibility of outcome measures
We will report number of missing items and calculate reliability of outcome measures
0 weeks; 4 weeks; 3 months
Adherence to ToR
We will report number of participants who completed at least 3 out of 4 ToR sessions
4 weeks.
Adherence to homework
determined by number of homework logs returned
4 weeks
Therapist adherence survey
Items assessing whether the therapist taught each of the skills included in each of the 4 sessions
4 weeks
Secondary Outcomes (6)
Pain Catastrophizing
0 Weeks, 4 Weeks, 3 Months
Pain Anxiety
0 Weeks, 4 Weeks, 3 Months
Depression
0 Weeks, 4 Weeks, 3 Months
Post Traumatic Stress Disorder
0 Weeks, 4 Weeks, 3 Months
Pain intensity
0 Weeks, 4 Weeks, 3 Months
- +1 more secondary outcomes
Study Arms (2)
Toolkit for Optimal Recovery after Injury
EXPERIMENTALThe Toolkit for Optimal Recovery after Injury (ToR) is a mind body skills based program delivered individually via secure live video. The format is a 4-week program with weekly meetings and a focus on teaching skills to optimize recovery and prevent chronic pain and disability.
Usual Care
NO INTERVENTIONThe Usual Care (UC) group will continue with their current medical care.
Interventions
The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.
Eligibility Criteria
You may qualify if:
- Diagnosis of musculoskeletal injury in the past 1-2 months
- years of age or older
- English fluency and literacy
- PCS OR, PASS score above median split
You may not qualify if:
- Major medical comorbidity expected to worsen in the next 6 months
- Comorbid chronic pain condition
- Antidepressant medication change in the past 6 months
- Secondary gains such as litigations or workers compensation procedures
- Diagnosis of psychosis, bipolar disorder or active substance dependence (by self report)
- Unwilling or unable to use videoconferencing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Vranceanu AM, Jacobs C, Lin A, Greenberg J, Funes CJ, Harris MB, Heng MM, Macklin EA, Ring D. Results of a feasibility randomized controlled trial (RCT) of the Toolkit for Optimal Recovery (TOR): a live video program to prevent chronic pain in at-risk adults with orthopedic injuries. Pilot Feasibility Stud. 2019 Feb 20;5:30. doi: 10.1186/s40814-019-0416-7. eCollection 2019.
PMID: 30820341DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana-Maria Vranceanu, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Psychologist
Study Record Dates
First Submitted
December 3, 2017
First Posted
January 23, 2018
Study Start
July 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
August 17, 2018
Record last verified: 2018-08