Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Study Details
Study Description
Brief Summary
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:
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Is the intervention feasible and acceptable to patients?
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pharmacist-led opioid taper intervention 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
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period
|
Outcome Measures
Primary Outcome Measures
- Acceptability [From enrollment until approximately 2 weeks after surgery]
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.
Secondary Outcome Measures
- Study Recruitment Rate [From enrollment until approximately 2 weeks after surgery]
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)
- Study Retention Rate [From enrollment until approximately 2 weeks after surgery]
In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.
- Taper Efficacy [From enrollment until the time of surgery]
change in opioid dose from enrollment through surgery
- Perioperative Pain [From enrollment until approximately 2 weeks after surgery]
pain scores throughout the perioperative period
Eligibility Criteria
Criteria
Inclusion Criteria:
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decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
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currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
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have a reliable telephone number for contact
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speaks English
Exclusion Criteria:
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Taking opioid medications that include:
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Buprenorphine
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Methadone
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Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
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Transdermal formations of opioid pain medications (e.g., fentanyl patches)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Hospital-Highlands | Birmingham | Alabama | United States | 35205 |
Sponsors and Collaborators
- University of Alabama at Birmingham
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Kevin R Riggs, MD, University of Alabama at Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-300009887
- 1K23AR080224-01A1