Safe Options for ACL Recovery

Study Overview
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Brief Summary
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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.

Detailed Description
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The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual [TAU] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics. There will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a booster intervention session of the intervention 3 days after surgery. In addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.

Official Title
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Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients

Conditions
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Opioid Use, Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Behavioral: ACL Opioid Exposure Reduction Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Under 12 years of age Contraindication to opioids Unable to understand intervention material in English

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment As Usual (TAU)<br>No intervention will be administered. | |
| Experimental: Opioid Exposure Reduction Program 1 (OERP1)<br>Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery. | Behavioral: ACL Opioid Exposure Reduction Program<br>* 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.<br>* Other names: ACL-OERP;|
| Experimental: Opioid Exposure Reduction Program 2 (OERP2)<br>Participants 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. | Behavioral: ACL Opioid Exposure Reduction Program<br>* 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.<br>* Other names: ACL-OERP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine milligram equivalents administered | Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts | Assessed at 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of safe opioid use | Change in pre and post test scores of a knowledge test of topics covered in the intervention including tolerance, weaning off opioids, safe disposal methods, and alternative pain management strategies. | Assessed at baseline and 7-days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention, opioid exposure, exposure reduction