Prevention of Opioid Use Disorder After Surgery
NCT04394559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2023-08-07
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
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