Safe Options for ACL Recovery
SOAR
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
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
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
February 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 3, 2022
CompletedNovember 2, 2022
October 1, 2022
2.3 years
January 7, 2020
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total morphine milligram equivalents administered
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts
Assessed at 30 days post surgery
Secondary Outcomes (1)
Knowledge of safe opioid use
Assessed at baseline and 7-days post surgery
Study Arms (3)
Treatment As Usual (TAU)
NO INTERVENTIONNo intervention will be administered.
Opioid Exposure Reduction Program 1 (OERP1)
EXPERIMENTALParticipants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.
Opioid Exposure Reduction Program 2 (OERP2)
EXPERIMENTALParticipants will engage in the same intervention as OERP1, but those in OERP2 will also receive a 5-minute "booster" intervention session 3 days after surgery.
Interventions
Subjects will engage in a brief, educational which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.
Eligibility Criteria
You may qualify if:
- Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.
- Be able to return to the clinic at least one time within the first 10 days post-op.
You may not qualify if:
- Under 12 years of age
- Contraindication to opioids
- Unable to understand intervention material in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karen Derefinko, PhDlead
- University of Memphiscollaborator
- Campbell Cliniccollaborator
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 13, 2020
Study Start
February 12, 2020
Primary Completion
June 3, 2022
Study Completion
June 3, 2022
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 2 years after data collection ends
It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.