Prevention of Opioid Use Disorder After Surgery
Status unconfirmed · Not applicable
Conditions studied: Opioid-use Disorder, Opioid Dependence, Opioid Use
In brief
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.
Key facts
- Study ID
- NCT04394559
- Run by
- Brigham and Women's Hospital
- People needed
- 204
- Starts
- 2021-07-02
- Expected to finish
- 2024-01-01
- Last updated by the study team
- 2023-08-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients admitted to orthopedic or neuro-surgical spine services at Brigham and Women's Hospital during the 6 month enrollment period
- English or Spanish speakers
- Patients who are and are not opioid-naïve for 30 days prior to admission based on their verified preadmission medication list and state-wide opioid prescription information.
- Undergo one of several designated orthopedic or spine surgeries, including trauma and arthroplasty surgeries.
- Age 18 or older
- Clinical discharge plan to home or short-term rehabilitation facility.
You may not qualify if…
- Not pregnant women, prisoners or institutionalized individuals
- Under the age of 18
- Current illicit opioid use.
- Patient is unable to provide informed consent, and has no available proxy
- Plan to be discharged to an acute care facility.
- Patient requires a second surgery or has medical condition requiring opioid use during the 6-month follow-up period (data are censored at time of second surgery).
Where it is running
- Jeffrey L Schnipper — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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