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Completed

NCT Number: NCT05358522

Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Guideline Adherent Opioid Prescriptions

    Time frame: ten months

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

Secondary outcomes

  1. Pills Prescribed

    Time frame: The duration of the study; two years

    The mean number of opioid pills prescribed per prescription

  2. Pills Taken

    Time frame: 28 days

    Mean number of patient-reported opioid pills taken

  3. Perceived ability to manage pain

    Time frame: 28 days

    Mean patient reported ability to manage pain on a 10 point scale (10=highest, 1=lowest)

  4. Number of Prescription Refills

    Time frame: 30 days

    Proportion of patients who had to refill opioid prescription by post-discharge day 30.

Other outcomes

  1. Health care utilization - Office Visits

    Time frame: 30 days

    30-day encounters rates for office visits

  2. Health care utilization - Telephone Calls

    Time frame: 30 days

    30-day encounters rates for telephone calls

  3. Health care utilization - Emergency Department Visits

    Time frame: 30 days

    30-day encounters rates for emergency department visits

  4. Health care utilization - Hospitalizations

    Time frame: 30 days

    30-day encounters rates for hospitalizations

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Learning Health System Clinician Feedback Using Patient-reported Data to Increase Implementation of Post-operative Opioid Prescribing Guidelines: a Stepped-wedge Cluster Randomized Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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