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Completed

NCT Number: NCT03536065

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Opioid Use Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Opioid Reduction Intervention

Behavioral

Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data

Current Care

Behavioral

Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: ORIOLES

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 24, 2018
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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