Prevention of Opioid Use Disorder After Surgery

NCT04394559 | Unknown DMC

• 1 other identifier: 2020P001387
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Persistent Opioid Use

  From prescription monitoring program (PMP) data, at least one filled opioid prescription 0-90 days after discharge and another 91-180 days after discharge.

  Post intervention: 90 days after discharge

• Persistent Opioid Use

  From prescription monitoring program (PMP) data, at least one filled opioid prescription 0-90 days after discharge and another 91-180 days after discharge.

  Post intervention: 180 days after discharge

Secondary Outcomes (10)

• Long-term Opioid Episodes

  180 days after discharge

• Pain Levels Post-Surgery

  90 days after discharge

• Pain Levels Post-Surgery

  180 days after discharge

• Function

  90 days after discharge

• Function

  180 days after discharge

Study Arms (2)

Usual care

NO INTERVENTION

inpatient pharmacists as available; standard discharge orders; standard follow up visit.

Intervention

EXPERIMENTAL

Discharge counseling; discharge opioid order set; post-discharge pain management follow up; patient pain management app.

Behavioral: Discharge Order Sets; Behavioral: Pharmacist-Led Discharge Counseling and Communication; Behavioral: Post-discharge Pain Management Follow-up; Behavioral: Patient Engagement Pain Management App

Interventions

Discharge Order Sets BEHAVIORAL

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.

Intervention

Pharmacist-Led Discharge Counseling and Communication BEHAVIORAL

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.

Intervention

Post-discharge Pain Management Follow-up BEHAVIORAL

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.

Intervention

Patient Engagement Pain Management App BEHAVIORAL

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

Intervention

Eligibility Criteria

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

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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Ohio State University: collaborator

Study Sites (1)

Jeffrey L Schnipper

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jeffrey L Schnipper, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Other: 2 arms, before-after study and mixed methods analysis of implementation

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 19, 2020
• Study Start: July 2, 2021
• Primary Completion: December 15, 2023
• Study Completion: January 1, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)