Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery

Prostate Cancer Clinical Trial

— ORIOLES  

Official title:

Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03536065
• Other study ID #: IRB00162359
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ORIOLES is a non-randomized, pre-post intervention study designed to improve quality of opioid prescribing and use after discharge for patients undergoing urologic surgery. The study will initially focus on a pre-defined cohort of patients undergoing radical prostatectomy. After the predefined study period for the pre-intervention arm, a three-part intervention is employed to assess the effect on opioid prescribing and use in the post-intervention arm. Pending results, the intervention may be applied to all surgeries in the department for routine clinical care.

Description:

The goal of the study is to reduce the amount of opioid analgesia prescribed after urologic surgery in the Department of Urology at Johns Hopkins. The initiative focuses on patients undergoing surgery for prostate cancer with radical prostatectomy including patients enrolled in IRB00123618/NCT03006562. The pre-intervention arm will consist of patients enrolled August 2017 to January 2018. The intervention arm will consist of patient enrolled January 2018 to completion of the study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• All patients diagnosed with prostate cancer and enrolled in NCT03006562

Exclusion Criteria:

• Patients not undergoing radical prostatectomy (for the primary pre-post ORIOLES study)

Related Conditions & MeSH terms

• Opioid Use
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Huang MM, Su ZT, Becker REN, Pavlovich CP, Partin AW, Allaf ME, Patel HD. Complications After Open and Robotic-Assisted Radical Prostatectomy and Association with Post-Operative Opioid Use: An Analysis of Data from the PREVENTER Trial. BJU Int. 2020 Jul 12. doi: 10.1111/bju.15172. [Epub ahead of print] — View Citation

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, — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Use	The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital	30 days
Secondary	Opioid Prescription	The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery	Discharge date
Secondary	Opioid Disposal	Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use	30 days
Secondary	Need for Refill or Additional Opioid Medication	Patient obtaining any additional opioid medication for post-surgical pain within 30 days after discharge from the hospital	30 days