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

NCT03659734 | Completed Results

• 2 other identifiers: IRB-431631R01DA045027-01A1
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Cessation

Outcome Measures

Primary Outcomes (1)

• Time to Opioid Cessation

  Time to opioid cessation between the two groups will be analyzed using survival analysis

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Number of Participants With Opioid Misuse (Postoperative COMM Score Greater Than or Equal to 9)

  Through study completion, 1 year after surgery

Study Arms (2)

Motivational Interviewing and Guided Opioid Tapering Support

EXPERIMENTAL

Behavioral: Motivational Interviewing and Guided Opioid Tapering Support

Enhanced Usual Care

EXPERIMENTAL

Behavioral: Enhanced Usual Care

Interventions

Motivational Interviewing and Guided Opioid Tapering Support BEHAVIORAL

Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.

Motivational Interviewing and Guided Opioid Tapering Support

Enhanced Usual Care BEHAVIORAL

Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford University School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jennifer Hah
• Organization: Stanford University

map_pain_study@stanford.edu

650-723-4000

Study Officials

• Jennifer Hah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: September 6, 2018
• Study Start: July 12, 2019
• Primary Completion: August 23, 2023
• Study Completion: March 3, 2024
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Locations

US (1)