search
Back to results

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

Primary Purpose

Prostate Cancer, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Opioid Reduction Intervention
Current Care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pre-Intervention

Post-Intervention

Arm Description

Current practice (unchanged)

Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education.

Outcomes

Primary Outcome Measures

Opioid Use
The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital

Secondary Outcome Measures

Opioid Prescription
The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery
Opioid Disposal
Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use
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

Full Information

First Posted
May 14, 2018
Last Updated
July 27, 2020
Sponsor
Johns Hopkins University
search

1. Study Identification

Unique Protocol Identification Number
NCT03536065
Brief Title
Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Opioid Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pre-Post Study Design with Non-Pharmacologic Intervention
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Intervention
Arm Type
Active Comparator
Arm Description
Current practice (unchanged)
Arm Title
Post-Intervention
Arm Type
Experimental
Arm Description
Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education.
Intervention Type
Behavioral
Intervention Name(s)
Opioid Reduction Intervention
Intervention Description
Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data
Intervention Type
Behavioral
Intervention Name(s)
Current Care
Intervention Description
Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention
Primary Outcome Measure Information:
Title
Opioid Use
Description
The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Opioid Prescription
Description
The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery
Time Frame
Discharge date
Title
Opioid Disposal
Description
Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use
Time Frame
30 days
Title
Need for Refill or Additional Opioid Medication
Description
Patient obtaining any additional opioid medication for post-surgical pain within 30 days after discharge from the hospital
Time Frame
30 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amin S Herati, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32654363
Citation
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.
Results Reference
background
PubMed Identifier
30352714
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: 10.1016/j.eururo.2018.10.013. Epub 2018 Oct 21.
Results Reference
result
PubMed Identifier
31643128
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, and Endoscopic Surgery (ORIOLES) Initiative. BJU Int. 2020 Mar;125(3):426-432. doi: 10.1111/bju.14932. Epub 2019 Nov 15.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs