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Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

Primary Purpose

Surgery, Opioid Use, Opioid Misuse

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Prescribing Report Cards
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Surgery focused on measuring Opioid Prescribing, Learning Health Systems, Prescription Use, Patient Reported Feedback

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Feedback

Opioid Prescribing Report Cards

Arm Description

No feedback about opioid prescribing behaviors.

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

Outcomes

Primary Outcome Measures

Guideline Adherent Opioid Prescriptions
Proportion of eligible surgical cases who received a guideline-adherent opioid prescription

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2022
Last Updated
October 16, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05358522
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Opioid Use, Opioid Misuse, Prescription Opioid Misuse
Keywords
Opioid Prescribing, Learning Health Systems, Prescription Use, Patient Reported Feedback

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Feedback
Arm Type
No Intervention
Arm Description
No feedback about opioid prescribing behaviors.
Arm Title
Opioid Prescribing Report Cards
Arm Type
Experimental
Arm Description
Procedure and prescribing providers will be randomized to when they will begin receiving individual reports on their opioid prescribing.
Intervention Type
Other
Intervention Name(s)
Opioid Prescribing Report Cards
Intervention Description
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 Outcome Measure Information:
Title
Guideline Adherent Opioid Prescriptions
Description
Proportion of eligible surgical cases who received a guideline-adherent opioid prescription
Time Frame
ten months
Secondary Outcome Measure Information:
Title
Pills Prescribed
Description
The mean number of opioid pills prescribed per prescription
Time Frame
The duration of the study; two years
Title
Pills Taken
Description
Mean number of patient-reported opioid pills taken
Time Frame
28 days
Title
Perceived ability to manage pain
Description
Mean patient reported ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Time Frame
28 days
Title
Number of Prescription Refills
Description
Proportion of patients who had to refill opioid prescription by post-discharge day 30.
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Health care utilization - Office Visits
Description
30-day encounters rates for office visits
Time Frame
30 days
Title
Health care utilization - Telephone Calls
Description
30-day encounters rates for telephone calls
Time Frame
30 days
Title
Health care utilization - Emergency Department Visits
Description
30-day encounters rates for emergency department visits
Time Frame
30 days
Title
Health care utilization - Hospitalizations
Description
30-day encounters rates for hospitalizations
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Kit Delgado, MD, MS
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anish Agarwal, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zarina Ali, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan Lee, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.
Citations:
PubMed Identifier
16829207
Citation
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Results Reference
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PubMed Identifier
28259174
Citation
Hemming K, Taljaard M, Forbes A. Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples. Trials. 2017 Mar 4;18(1):101. doi: 10.1186/s13063-017-1833-7.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
3719049
Citation
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Results Reference
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PubMed Identifier
31404063
Citation
Starks MA, Sanders GD, Coeytaux RR, Riley IL, Jackson LR 2nd, Brooks AM, Thomas KL, Choudhury KR, Califf RM, Hernandez AF. Assessing heterogeneity of treatment effect analyses in health-related cluster randomized trials: A systematic review. PLoS One. 2019 Aug 12;14(8):e0219894. doi: 10.1371/journal.pone.0219894. eCollection 2019.
Results Reference
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PubMed Identifier
14746439
Citation
Hogan JW, Lancaster T. Instrumental variables and inverse probability weighting for causal inference from longitudinal observational studies. Stat Methods Med Res. 2004 Feb;13(1):17-48. doi: 10.1191/0962280204sm351ra.
Results Reference
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Increasing Implementation of Post-Operative Opioid Prescribing Guidelines

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