Prevention of Opioid Use Disorder After Surgery

NCT04394559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2023-08-07

No results posted yet for this study

Summary

The objective of this study is to design, implement, and pilot test a multi-faceted intervention to support safer opioid prescribing, self-administration, and monitoring and reduce persistent opioid use and opioid use disorder for patients transitioning to the community setting after major orthopedic surgery. The multi-faceted intervention includes: 1) communication with outpatient providers and counseling of patients and caregivers at hospital discharge; 2) standardized opioid prescribing discharge order sets for each type of surgery; 3) an outpatient pain management follow-up visit embedded within routine post-operative care for managing pain and opioid use, and 4) a mobile patient-reported outcomes application for assessing pain, function, and possible development of opioid use disorder (OUD). The primary outcome will be persistent opioid use (in the 6 months after surgery) based on state-wide prescription data. Secondary outcomes will include the total morphine-equivalent dose of opioids prescribed at discharge; total post-operative opioids dispensed in the 6 months after surgery; and self-reported opioid misuse, pain and function 90 and 180 days after surgery.

Conditions

  • Opioid-use Disorder
  • Opioid Dependence
  • Opioid Use

Interventions

BEHAVIORAL

Discharge Order Sets

Discharge order sets will be implemented in the electronic health record and will provide surgeons a guideline for a recommended dose and duration of opioids for each commonly performed orthopedic surgery.

BEHAVIORAL

Pharmacist-Led Discharge Counseling and Communication

Two visits by a trained inpatient pharmacist, including an intake visit to determine previous barriers to safe medication use, and a discharge counseling session with patients and caregivers regarding safe and effective opioid use after discharge; pharmacist communication with providers regarding the post-discharge pain management plan.

BEHAVIORAL

Post-discharge Pain Management Follow-up

An outpatient pharmacist pain management follow-up visit (with additional contact as needed) embedded within routine post-operative care for managing pain and opioid use.

BEHAVIORAL

Patient Engagement Pain Management App

A mobile patient-reported outcomes application for assessing pain, function, and possible development of opioid use disorder.

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER
  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Jeffrey L Schnipper, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2023-12-15
Completion
2024-01-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04394559 on ClinicalTrials.gov