Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

NCT05358522 | Completed

• 1 other identifier: 850959
• Study Type: interventional
• Target: 26,562
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Opioid Use; Opioid Misuse; Prescription Opioid Misuse

Keywords

Opioid Prescribing; Learning Health Systems; Prescription Use; Patient Reported Feedback

Outcome Measures

Primary Outcomes (1)

• Guideline Adherent Opioid Prescriptions

  Proportion of eligible surgical cases who received a guideline-adherent opioid prescription

  ten months

Secondary Outcomes (4)

• Pills Prescribed

  The duration of the study; two years

• Pills Taken

  28 days

• Perceived ability to manage pain

  28 days

• Number of Prescription Refills

  30 days

Other Outcomes (4)

• Health care utilization - Office Visits

  30 days

• Health care utilization - Telephone Calls

  30 days

• Health care utilization - Emergency Department Visits

  30 days

Study Arms (2)

Standard Feedback

NO INTERVENTION

No feedback about opioid prescribing behaviors.

Opioid Prescribing Report Cards

EXPERIMENTAL

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

Other: Opioid Prescribing Report Cards

Interventions

Opioid Prescribing Report Cards 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.

Opioid Prescribing Report Cards

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

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  PMID: 14746439 BACKGROUND

• Agarwal AK, Ebert JP, Xiong R, Ali ZS, Lee D, Shofer F, Gitelman Y, Do D, Spencer EA, Grenader EM, Li F, Harhay MO, Delgado MK. Peer and Patient Feedback to Increase Adherence to Postoperative Opioid Prescribing Guidelines: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Surg. 2025 Aug 1;160(8):866-874. doi: 10.1001/jamasurg.2025.1672.

  PMID: 40498501 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• M. Kit Delgado, MD, MS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Anish Agarwal, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Zarina Ali, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Dan Lee, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Emergency Medicine and Epidemiology

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: May 3, 2022
• Study Start: June 1, 2022
• Primary Completion: May 5, 2023
• Study Completion: November 5, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)