Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Study Overview
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Brief Summary
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The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are: Is the intervention feasible and acceptable to patients? Does the intervention result in a decrease in opioid dose during the preoperative period? Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.

Official Title
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Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development

Conditions
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Arthritis Knee, Arthritis Hip, Chronic Pain

Intervention / Treatment
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* Behavioral: opioid taper


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months have a reliable telephone number for contact speaks English Exclusion Criteria: Taking opioid medications that include: Buprenorphine Methadone Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine) Transdermal formations of opioid pain medications (e.g., fentanyl patches)

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist-led opioid taper intervention<br>The participant will attempt to taper their opioid dose by  50% during the 4-6 week preoperative period. Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary. | Behavioral: opioid taper<br>* The participant will attempt to taper their opioid dose by  50% during the 4-6 week preoperative period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Mixed-methods assessment of the intervention by participants. Participants will provide qualitative feedback at multiple points during and after the intervention, and will quantitatively rate satisfaction at the end of the study. These results will be analyzed jointly to determine acceptability. | From enrollment until approximately 2 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Recruitment Rate | In order to assess feasibility of the taper intervention, we will track the proportion of participants who are offered enrollment that ultimately enroll (will be measured separately for those offered enrollment in person and those who are mailed information about the study) | From enrollment until approximately 2 weeks after surgery | 
| Study Retention Rate | In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit. | From enrollment until approximately 2 weeks after surgery | 
| Taper Efficacy | change in opioid dose from enrollment through surgery | From enrollment until the time of surgery | 
| Perioperative Pain | pain scores throughout the perioperative period | From enrollment until approximately 2 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioids