Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

Not Applicable

Completed

• Conditions: Surgery; Opioid Use; Opioid Misuse; Prescription Opioid Misuse
• Interventions: Other: Opioid Prescribing Report Cards

• Registration Number: NCT05358522
• Lead Sponsor: University of Pennsylvania

Brief Summary

The objective of this research study is to evaluate the effect of a quality improvement initiative carried out by a health system opioid stewardship task force aiming to increase clinician post-operative prescribing adherence with procedure specific guidelines that were developed using patient reported data. The feedback compares the clinician's average number of opioid pills prescribed after a given procedure to other clinicians in the health system and to the health system guideline recommended amount based on patient reported data on opioid pills taken for that procedure. The feedback also provides historical data on mean patient reported number opioid pills taken following a given procedure and on patients' ability to manage pain among those who received guideline adherent prescriptions compared with patients who received greater than the guideline recommended amount.

Detailed Description

This research study will analyze results from a Penn Medicine Opioid Task Force initiative using a two-arm stepped-wedge cluster randomized trial design. The feedback intervention will be rolled out across all participating Penn Medicine surgical departments and divisions currently using Penn Medicine's post-operative text-messaging learning health system platform. Timing of intervention roll-out within each department and division will be randomly assigned to permit evaluation of the effect of the intervention.

With the stepped wedge design, not only will all attendings and associated prescribers ultimately receive the intervention, but by the end of the trial, each will be actively using the intervention, meaning its sustenance would occur automatically. A stepped-wedge design will be utilized, in which all clinicians begin in usual care and the order in which they adopt interventions is randomly assigned, because it has both practical and scientific advantages over traditional parallel-cluster randomized designs, in which randomization determines which clusters adopt the intervention at all. Importantly, the stepped-wedge design provides time to prepare surgical divisions for implementation of the intervention(s), enhances stakeholders' enthusiasm for participating by ensuring that each will receive the intervention(s), and typically increases statistical power. The primary analysis of study outcomes will be conducted at the patient-level. Secondary analyses will be conducted at the prescriber and attending surgeon level.

Study Timeline

• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-03
• Study Start: 2022-06-01
• Primary Completion: 2023-05-05
• Study Completion: 2023-11-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26562

Inclusion Criteria

• All surgical prescribers (surgeons, advanced practice providers or resident physicians) who have written at least 5 opioid prescriptions per month for patients undergoing an eligible procedure during the baseline period or attending surgeons who performed an eligible procedure during the baseline period.
• Procedures are eligible to be included if there are a minimum of 10 unique cases during any given month and post-operative opioids are prescribed. Data on patient reported opioid use, pain scores, and ability to manage pain is currently being collected by Penn Medicine's post-operative text messaging platform. As of February 15, 2022, there were 30 procedures defined by Current Procedural Terminology (CPT) groupings that meet these criteria.
• In the research study analysis, patients will be included in the primary sample if they (1) undergo an eligible surgical procedure by an eligible attending surgeon, and (2) the proportion of guideline compliant prescriptions written during the baseline period for that procedure was less than 90%.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Prescribing Report Cards	Opioid Prescribing Report Cards	Procedure and prescribing providers will be randomized to when they will begin receiving individual reports on their opioid prescribing.

Primary Outcome Measures

Name	Time	Method
Guideline Adherent Opioid Prescriptions	ten months	Proportion of eligible surgical cases who received a guideline-adherent opioid prescription

Secondary Outcome Measures

Name	Time	Method
Pills Taken	28 days	Mean number of patient-reported opioid pills taken
Pills Prescribed	The duration of the study; two years	The mean number of opioid pills prescribed per prescription
Perceived ability to manage pain	28 days	Mean patient reported ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Number of Prescription Refills	30 days	Proportion of patients who had to refill opioid prescription by post-discharge day 30.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States