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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536065
Recruitment Status : Completed
First Posted : May 24, 2018
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Opioid Use Behavioral: Opioid Reduction Intervention Behavioral: Current Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Pre-Post Study Design with Non-Pharmacologic Intervention
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pre-Intervention
Current practice (unchanged)
Behavioral: Current Care
Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention

Experimental: Post-Intervention
Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education.
Behavioral: Opioid Reduction Intervention
Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data




Primary Outcome Measures :
  1. Opioid Use [ Time Frame: 30 days ]
    The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital


Secondary Outcome Measures :
  1. Opioid Prescription [ Time Frame: Discharge date ]
    The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery

  2. Opioid Disposal [ Time Frame: 30 days ]
    Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use

  3. Need for Refill or Additional Opioid Medication [ Time Frame: 30 days ]
    Patient obtaining any additional opioid medication for post-surgical pain within 30 days after discharge from the hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536065


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Amin S Herati, MD Johns Hopkins University
Publications of Results:
Other Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03536065    
Other Study ID Numbers: IRB00162359
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents