Motivational Interviewing and Guided Opioid Tapering Support to Promote Postoperative Opioid Cessation

Not Applicable

Completed

• Conditions: Opioid Cessation
• Interventions: Behavioral: Motivational Interviewing and Guided Opioid Tapering Support; Behavioral: Enhanced Usual Care

• Registration Number: NCT03659734
• Lead Sponsor: Stanford University

Brief Summary

The purpose of this study is to evaluate the relative efficacy of enhanced usual care versus motivational interviewing and guided opioid tapering support to promote opioid cessation after total hip or knee replacement surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2019-07-12
• Primary Completion: 2023-08-23
• Study Completion: 2024-03-03
• Results First Submitted: 2024-11-09
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Results First Posted: 2025-01-17
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

• Planning to undergo surgery
• English speaking
• Ability and willingness to complete questionnaires and assessments
• Scheduled for total hip, knee, or shoulder replacement
• Preoperative opioid use and opioid use 14 days after surgery to increase the likelihood of delayed opioid cessation.
• Not under the care of a current pain management provider

Exclusion Criteria

• Any conditions causing inability to complete assessments
• Known pregnancy
• Elevated suicidality
• Enrollment in conflicting perioperative trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motivational Interviewing and Guided Opioid Tapering Support	Motivational Interviewing and Guided Opioid Tapering Support	-
Enhanced Usual Care	Enhanced Usual Care	-

Primary Outcome Measures

Name	Time	Method
Time to Opioid Cessation	Through study completion, an average of 1 year	Time to opioid cessation between the two groups will be analyzed using survival analysis

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)	Through study completion, 1 year after surgery	Assessed by total score on the Current Opioid Misuse Measure (COMM). The Current Opioid Misuse Measure is a self-report measure of risk for aberrant medication related behavior among persons who are prescribed opioids for pain. The COMM contains 17 items rated from 0="never" to 4="very often" . The 17 items are summed to create a total score with a minimum of 0 to a maximum of 68. Higher scores represent a higher risk of potential opioid medication misuse (worse outcome). Patients exhibiting opioid misuse (binary outcome) were defined as those reporting a postoperative COMM score greater than or equal to 9.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States