Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-02-12
2022-06-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Treatment As Usual (TAU)
No intervention will be administered.
No interventions assigned to this group
Opioid Exposure Reduction Program 1 (OERP1)
Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.
ACL Opioid Exposure Reduction Program
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.
Opioid Exposure Reduction Program 2 (OERP2)
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.
ACL Opioid Exposure Reduction Program
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.
Interventions
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ACL Opioid Exposure Reduction Program
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be able to return to the clinic at least one time within the first 10 days post-op.
Exclusion Criteria
* Contraindication to opioids
* Unable to understand intervention material in English
12 Years
ALL
No
Sponsors
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University of Memphis
OTHER
Campbell Clinic
OTHER
Karen Derefinko, PhD
OTHER
Responsible Party
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Karen Derefinko, PhD
Assistant Professor
Locations
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University of Tennessee Health Science Center
Memphis, Tennessee, United States
Countries
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Related Links
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UTHSC main website
Other Identifiers
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19-07075-XP
Identifier Type: -
Identifier Source: org_study_id
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