Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26562 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-11-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing

NCT04776928

Opioid Prescribing

COMPLETED NA

Distribution of Medication Disposal Packets - Acute Opioid Prescribing

NCT05169281

Orthopedic Surgery Neurosurgery Surgery +2 more

COMPLETED NA

Nudges for Opioid Reduction After Major Surgery Trial

NCT04927351

Surgery

ACTIVE_NOT_RECRUITING NA

Does Altering Narcotic Prescription Methods Affect Opioid Distribution Following Select Upper Extremity Surgeries?

NCT03570320

Opioid Use

COMPLETED NA

Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

NCT05221866

Opioid Use Opioid Dependence Opioid Misuse +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery Opioid Use Opioid Misuse Prescription Opioid Misuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Feedback

No feedback about opioid prescribing behaviors.

Group Type NO_INTERVENTION

No interventions assigned to this group

Opioid Prescribing Report Cards

Procedure and prescribing providers will be randomized to when they will begin receiving individual reports on their opioid prescribing.

Group Type EXPERIMENTAL

Opioid Prescribing Report Cards

Intervention Type OTHER

Initial comparison: Clinicians will receive an initial peer comparison feedback report by email in which their post-operative opioid prescribing for patients undergoing their top 3 procedures is compared to the guideline recommended doses and the mean prescribing doses by other University of Pennsylvania Health System (UPHS) prescribers for each of those 3 procedures since the start of the baseline period.

Furthermore, in an attached report, for each of the 3 procedures, the mean patient reported ability to manage pain one week at home after the procedure will be displayed for those who received guideline compliant dosages of opioids relative to those who received higher than guideline recommended amounts.

Monthly comparison: On a monthly basis clinicians will get a report providing similar peer comparison feedback as above but with a monthly trend line of their performance since the start of the intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Opioid Prescribing Report Cards

Initial comparison: Clinicians will receive an initial peer comparison feedback report by email in which their post-operative opioid prescribing for patients undergoing their top 3 procedures is compared to the guideline recommended doses and the mean prescribing doses by other University of Pennsylvania Health System (UPHS) prescribers for each of those 3 procedures since the start of the baseline period.

Furthermore, in an attached report, for each of the 3 procedures, the mean patient reported ability to manage pain one week at home after the procedure will be displayed for those who received guideline compliant dosages of opioids relative to those who received higher than guideline recommended amounts.

Monthly comparison: On a monthly basis clinicians will get a report providing similar peer comparison feedback as above but with a monthly trend line of their performance since the start of the intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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%.