Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery
NCT ID: NCT03536065
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
443 participants
INTERVENTIONAL
2017-08-01
2019-03-01
Brief Summary
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Detailed Description
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The intervention consists of a information discharge sheet, a standardized prescribing guideline at discharge, and nurses providing improved education for patients at discharge about appropriate use of opioid medication, routes for disposal, and potential side effects. Data on prescriptions written (amount and type of mediation) and use of opioid and other pain medication after surgery will be compared before and after the quality improvement initiative is started. Outcomes are assessed via 30-day phone call follow-up with data on perioperative outcomes, postoperative medication use, and symptoms already assessed in IRB00123618/NCT03006562. At the completion of the pre-intervention arm, providers in the urology department are informed about the average and distribution of usage of post-discharge opioids. Education and standardized prescribing (allowing for provider judgment) may help reduce/personalize the amount of opioids prescribed at discharge to reduce wasted medication entering circulation. The initiative may then be expanded to encompass all surgeries in the department to reduce opioid prescribing and use for routine clinical care.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Pre-Intervention
Current practice (unchanged)
Current Care
Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention
Post-Intervention
Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education.
Opioid Reduction Intervention
Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data
Interventions
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Opioid Reduction Intervention
Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data
Current Care
Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
MALE
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Amin S Herati, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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Huang MM, Su ZT, Becker REN, Pavlovich CP, Partin AW, Allaf ME, Patel HD. Complications after open and robot-assisted radical prostatectomy and association with postoperative opioid use: an analysis of data from the PREVENTER trial. BJU Int. 2021 Feb;127(2):190-197. doi: 10.1111/bju.15172. Epub 2020 Aug 17.
Patel HD, Srivastava A, Patel ND, Faisal FA, Ludwig W, Joice GA, Schwen ZR, Allaf ME, Han M, Herati AS. A Prospective Cohort Study of Postdischarge Opioid Practices After Radical Prostatectomy: The ORIOLES Initiative. Eur Urol. 2019 Feb;75(2):215-218. doi: 10.1016/j.eururo.2018.10.013. Epub 2018 Oct 21.
Patel HD, Faisal FA, Patel ND, Pavlovich CP, Allaf ME, Han M, Herati AS. Effect of a prospective opioid reduction intervention on opioid prescribing and use after radical prostatectomy: results of the Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES) Initiative. BJU Int. 2020 Mar;125(3):426-432. doi: 10.1111/bju.14932. Epub 2019 Nov 15.
Other Identifiers
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IRB00162359
Identifier Type: -
Identifier Source: org_study_id
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