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

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03659734

Collaborator

(none)

450

Enrollment

Location

Arms

46.7

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Cessation	Behavioral: Motivational Interviewing and Guided Opioid Tapering Support Behavioral: Enhanced Usual Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial to Evaluate the Relative Efficacy of Motivational Interviewing and Guided Opioid Tapering Support vs. Enhanced Usual Care to Promote Opioid Cessation After Orthopedic Surgery

Actual Study Start Date :

Jul 12, 2019

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Motivational Interviewing and Guided Opioid Tapering Support	Behavioral: Motivational Interviewing and Guided Opioid Tapering Support 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.
Experimental: Enhanced Usual Care	Behavioral: Enhanced Usual Care 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.

Arm

Intervention/Treatment

Experimental: Motivational Interviewing and Guided Opioid Tapering Support

Behavioral: Motivational Interviewing and Guided Opioid Tapering Support

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.

Experimental: Enhanced Usual Care

Behavioral: Enhanced Usual Care

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.

Outcome Measures

Primary Outcome Measures

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

Opioid Misuse [Through study completion, an average of 1 year]
Participant score on the Current Opioid Misuse Measure and prescription information obtained via CURES 2.0 will be used to assess opioid misuse behaviors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Jennifer Hah, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Hah, Principal Investigator, Stanford University

ClinicalTrials.gov Identifier:

NCT03659734

Other Study ID Numbers:

IRB-43163

First Posted:

Sep 6, 2018

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Analgesics, Opioid

Study Results

No Results Posted as of Jun 8, 2022