Opioid Reduction Program for Total Knee Replacement Patients

Study Overview
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Brief Summary
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In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

Detailed Description
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The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups. There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened booster session approximately 2-weeks post-op.

Official Title
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Opioid Reduction Program for Total Knee Replacement Patients

Conditions
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Knee Injuries, Knee Injuries and Disorders, Opioid Use

Intervention / Treatment
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* Behavioral: Opioid Reduction Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription. Access to a telephone. Able to consent in English. Exclusion Criteria: Under the age of 18. Contraindications to use of opioid medication. No access to a telephone. Unable to understand consent materials in English.

Ages Eligible for Study
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Minimum Age: 18 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 Reduction Program<br>Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery. | Behavioral: Opioid Reduction Program<br>* Subjects will engage in a brief, educational session 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: TKR-ORP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid pills (dose and type) prescribed by Campbell Clinic. | transcribed from medical record at Campbell Clinic | 12-weeks post-op. | 
| Opioid pills prescribed outside of Campbell Clinic. | assessed via scan of prescription drug monitoring database for Tennessee | 12-weeks post-op. | 
| Opioid pill count questionnaire. | self-report from participant of how many opioids are left in the bottle at the 12 week assessment | 12-weeks post-op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS Jr. | There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme | 12-weeks post-op. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Total Knee Replacement, Knee Arthroplasty, Knee Injuries, Prevention, Analgesics, Opioid