Prostate CancerORIOLESNCT03536065
Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery
A study testing Opioid Reduction Intervention and Current Care in people with Prostate Cancer and Opioid Use, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Opioid Use
- What is being tested?
- Opioid Reduction Intervention and Current Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 1 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with prostate cancer and enrolled in NCT03006562
Who cannot join
- Patients not undergoing radical prostatectomy (for the primary pre-post ORIOLES study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education
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.
Read the 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.
- Conditions
- Prostate Cancer, Opioid Use
- Being tested
- Opioid Reduction Intervention, Current Care
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Reduction InterventionBehavioural
Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data
Current CareBehavioural
Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention | Active comparator | Current practice (unchanged) Receives: Behavioral: Current Care |
| Post-Intervention | Experimental | Reduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education. Receives: Behavioral: Opioid Reduction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Use
The total oral morphine equivalents (OMEQ) used by the patient up to 30 days after discharge from the hospital
Measured: 30 days
Secondary outcomes (3)
Opioid Prescription
The total oral morphine equivalents (OMEQ) prescribed by the inpatient provider to the patient at discharge after surgery
Measured: Discharge date
Opioid Disposal
Method of disposal (if any) by the patient of opioid medication prescribed for post-discharge use
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Aug 2017
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-Post Study Design with Non-Pharmacologic Intervention
- Masking
- None (open label)
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amin S Herati, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536065
- Sponsor's protocol ID
- IRB00162359
- Acronym
- ORIOLES
- Status last verified
- Jul 2020
- First submitted
- 14 May 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32654363Patel 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.
PubMed 30352714Patel 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.
PubMed 31643128
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Discharge Opioid Reduction Intervention for Open, Laparoscopic, and Endoscopic Surgery (ORIOLES): A Quality Improvement Study of Prescribing Habits and Patient Education
- ClinicalTrials.gov ID
- NCT03536065
- Acronym / sponsor ID
- ORIOLES / IRB00162359
- Conditions
- Prostate Cancer, Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-Post Study Design with Non-Pharmacologic Intervention
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention | Active comparator | Behavioral: Current CareCurrent practice (unchanged) |
| Post-Intervention | Experimental | Behavioral: Opioid Reduction InterventionReduction of opioid prescription based on Pre-Intervention data, implementation of a discharge sheet and nursing education. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients diagnosed with prostate cancer and enrolled in NCT03006562
Key exclusion criteria (1 listed)
- Patients not undergoing radical prostatectomy (for the primary pre-post ORIOLES study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Reduction InterventionPatient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data | Behavioural | Post-Intervention |
| Current CareCurrent unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention | Behavioural | Pre-Intervention |
Primary outcome
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
3 secondary outcomes
Opioid Prescription
Time frame: Discharge date
Opioid Disposal
Time frame: 30 days
Need for Refill or Additional Opioid Medication
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 32654363Huang 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 publication: PubMed 30352714Patel 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 publication: PubMed 31643128Patel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amin S Herati, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Reduction Intervention and Current Care in people with Prostate Cancer and Opioid Use, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Use (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03536065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.