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Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

Primary Purpose

Arthritis Knee, Arthritis Hip, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
opioid taper
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis Knee focused on measuring Opioids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • UAB Hospital-HighlandsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pharmacist-led opioid taper intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
Taper Efficacy
change in opioid dose from enrollment through surgery
Perioperative Pain
pain scores throughout the perioperative period

Full Information

First Posted
March 2, 2023
Last Updated
August 29, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05788016
Brief Title
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Official Title
Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty: Phase 2 Intervention Development
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee, Arthritis Hip, Chronic Pain
Keywords
Opioids

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacist-led opioid taper intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
opioid taper
Intervention Description
The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period
Primary Outcome Measure Information:
Title
Acceptability
Description
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.
Time Frame
From enrollment until approximately 2 weeks after surgery
Secondary Outcome Measure Information:
Title
Study Recruitment Rate
Description
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)
Time Frame
From enrollment until approximately 2 weeks after surgery
Title
Study Retention Rate
Description
In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit.
Time Frame
From enrollment until approximately 2 weeks after surgery
Title
Taper Efficacy
Description
change in opioid dose from enrollment through surgery
Time Frame
From enrollment until the time of surgery
Title
Perioperative Pain
Description
pain scores throughout the perioperative period
Time Frame
From enrollment until approximately 2 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin R Riggs, MD
Phone
205-934-0778
Email
kriggs@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shakristal Williams
Phone
205-934-2304
Email
shakristalwilliams@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin R Riggs, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Hospital-Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

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