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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer, Opioid Use

Intervention / Treatment
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* Behavioral: Opioid Reduction Intervention
* Behavioral: Current Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pre-Post Study Design with Non-Pharmacologic Intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-Intervention<br>Current practice (unchanged) | Behavioral: Current Care<br>* Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention<br>|
| Experimental: Post-Intervention<br>Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education. | Behavioral: Opioid Reduction Intervention<br>* Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use | The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Prescription | The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery | Discharge date | 
| Opioid Disposal | Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use | 30 days | 
| 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 |