Clinical trial NCT05358522: Increasing Implementation of Post-Operative Opioid Prescribing Guidelines
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Opioid Use
Opioid Misuse
Prescription Opioid Misuse
Keywords: Opioid Prescribing
Learning Health Systems
Prescription Use
Patient Reported Feedback
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 26562
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Guideline Adherent Opioid Prescriptions
timeFrame: ten months
Secondary outcomes:
measure: Pills Prescribed
timeFrame: The duration of the study; two years
measure: Pills Taken
timeFrame: 28 days
measure: Perceived ability to manage pain
timeFrame: 28 days
measure: Number of Prescription Refills
timeFrame: 30 days
Other outcomes:
measure: Health care utilization - Office Visits
timeFrame: 30 days
measure: Health care utilization - Telephone Calls
timeFrame: 30 days
measure: Health care utilization - Emergency Department Visits
timeFrame: 30 days
measure: Health care utilization - Hospitalizations
timeFrame: 30 days
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: M. Kit Delgado, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Anish Agarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Zarina Ali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Dan Lee, MD
role: PRINCIPAL_INVESTIGATOR
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