SurgeryNCT05358522
Increasing Implementation of Post-Operative Opioid Prescribing Guidelines
A study testing Opioid Prescribing Report Cards in people with Surgery and Opioid Use, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgery, Opioid Use, Opioid Misuse
- What is being tested?
- Opioid Prescribing Report Cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,562 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 5 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Surgery, Opioid Use, Opioid Misuse, Prescription Opioid Misuse
- Being tested
- Opioid Prescribing Report Cards
- Keywords
- Opioid Prescribing, Learning Health Systems, Prescription Use, Patient Reported Feedback
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Prescribing Report CardsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Opioid Prescribing Report Cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline Adherent Opioid Prescriptions
Proportion of eligible surgical cases who received a guideline-adherent opioid prescription
Measured: ten months
Secondary outcomes (4)
Pills Prescribed
The mean number of opioid pills prescribed per prescription
Measured: The duration of the study; two years
Pills Taken
Mean number of patient-reported opioid pills taken
Measured: 28 days
Perceived ability to manage pain
Mean patient reported ability to manage pain on a 10 point scale (10=highest, 1=lowest)
Measured: 28 days
Number of Prescription Refills
Proportion of patients who had to refill opioid prescription by post-discharge day 30.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Jun 2022
- Primary completion5 May 2023
- Study completion5 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26,562 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Kit Delgado, MD, University of Pennsylvania
- Investigators
- M. Kit Delgado, MD, MS, Principal investigator, University of PennsylvaniaAnish Agarwal, MD, MPH, Principal investigator, University of PennsylvaniaZarina Ali, MD, Principal investigator, University of PennsylvaniaDan Lee, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358522
- Sponsor's protocol ID
- 850959
- Status last verified
- Feb 2024
- First submitted
- 17 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
PubMed 16829207Hemming 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.
PubMed 28259174White H. A Heteroskedasticity-Consistent Covariance-Matrix Estimator and a Direct Test for Heteroskedasticity. Econometrica 1980;48:817-38.
Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986 Mar;42(1):121-30.
PubMed 3719049Starks 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.
PubMed 31404063Hogan 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.
PubMed 14746439Agarwal 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.
PubMed 40498501
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05358522
- Acronym / sponsor ID
- 850959
- Conditions
- Surgery, Opioid Use, Opioid Misuse, Prescription Opioid Misuse
- Keywords
- Opioid Prescribing, Learning Health Systems, Prescription Use, Patient Reported Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,562 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 Nov 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Feedback | No intervention | –No feedback about opioid prescribing behaviors. |
| Opioid Prescribing Report Cards | Experimental | Other: Opioid Prescribing Report CardsProcedure and prescribing providers will be randomized to when they will begin receiving individual reports on their opioid prescribing. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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%.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Prescribing Report CardsInitial 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. | Other | Opioid Prescribing Report Cards |
Primary outcome
Guideline Adherent Opioid Prescriptions
Time frame: ten months
Proportion of eligible surgical cases who received a guideline-adherent opioid prescription
4 secondary outcomes
Pills Prescribed
Time frame: The duration of the study; two years
Pills Taken
Time frame: 28 days
Perceived ability to manage pain
Time frame: 28 days
Number of Prescription Refills
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 16829207Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007 Feb;28(2):182-91. doi: 10.1016/j.cct.2006.05.007. Epub 2006 Jul 7.
- Background: PubMed 28259174Hemming 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.
- BackgroundWhite H. A Heteroskedasticity-Consistent Covariance-Matrix Estimator and a Direct Test for Heteroskedasticity. Econometrica 1980;48:817-38.
- Background: PubMed 3719049Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986 Mar;42(1):121-30.
- Background: PubMed 31404063Starks 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.
- Background: PubMed 14746439Hogan 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.
- Derived from this study: PubMed 40498501Agarwal 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Surgery
Not yet recruiting
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
mERAS Intervention, The ASA (American Society of Anesthesiologists) Score
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Ganglioneuroblastoma, Nodular, Neuroblastoma
Not yet recruiting
The Effect of Compound Chamomile and Lidocaine Hydronchloride Gel as an Endotracheal Tube Lubricant on Postoperative Pharyngeal and Laryngeal Complications in Thoracic Surgery Patients
Postoperative Sore Throat
Active, not recruitingObservational study
Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
Spinal Cord Injury, Spinal Cord Injury at C5-C7 Level
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Kit Delgado, MD, MS principal investigator
University of Pennsylvania
Anish Agarwal, MD, MPH principal investigator
University of Pennsylvania
Zarina Ali, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Prescribing Report Cards in people with Surgery and Opioid Use, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline Adherent Opioid Prescriptions (time frame: ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05358522, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.