NCT03536065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

May 14, 2018

Last Update Submit

July 27, 2020

Conditions

Prostate CancerOpioid Use

Outcome Measures

Primary Outcomes (1)

  • Opioid Use

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

    30 days

Secondary Outcomes (3)

  • Opioid Prescription

    Discharge date

  • Opioid Disposal

    30 days

  • Need for Refill or Additional Opioid Medication

    30 days

Study Arms (2)

Pre-Intervention

ACTIVE COMPARATOR

Current practice (unchanged)

Behavioral: Current Care

Post-Intervention

EXPERIMENTAL

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

Behavioral: Opioid Reduction Intervention

Interventions

Opioid Reduction InterventionBEHAVIORAL

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

Post-Intervention
Current CareBEHAVIORAL

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

Pre-Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients diagnosed with prostate cancer and enrolled in NCT03006562

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

  • 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.

    PMID: 32654363BACKGROUND

  • 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.

    PMID: 30352714RESULT

  • 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.

    PMID: 31643128RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Amin S Herati, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Pre-Post Study Design with Non-Pharmacologic Intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

August 1, 2017

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)