Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21689 participants
INTERVENTIONAL
2020-07-07
2021-06-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use prior to discharge serves as a reliable indicator to estimate needs for analgesic medications at home. The investigators will test the hypothesis that the existing tool will enable providers to write need-based prescriptions based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The investigators will test this tool prospectively in a cohort of \~1,000 providers (primary subjects) and \~39,000 surgical patients (secondary subjects) in four University of Colorado Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the intervention).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
NCT05221866
No Opioids PrescrIptions On Discharge After Surgery
NCT04469868
Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery
NCT03034278
Nudges for Opioid Reduction After Major Surgery Trial
NCT04927351
Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing
NCT04776928
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Based on the relationship between opioids taken prior to discharge and post-discharge opioid intake described above as well as published guidelines for post-discharge prescriptions after surgery will use a tiered approach towards determining the total amount of opioids to be prescribed. Accordingly, the investigators have integrated an algorithm into the BPA such that opioid intake from the EHR only triggers the BPA if the total amount of prescribed opioids exceeds the predicted thresholds.
The opioid prescribing BPA will be assessed over a 44-week period in all eligible patients. At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider and will be tracked. The investigators will use an all "On" vs. all "Off" configuration to answer the questions if the average amount of total opioids per post-discharge prescription is lower with the BPA active. The investigation will commence with two "Off" periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two "On" periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BPA Off
No best-practice alert (BPA) message is displayed to providers.
No interventions assigned to this group
BPA On
BPA message is displayed to providers based on patient opioid intake as reported in the electronic health record (EHR).
BPA
At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BPA
At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
• Credentialed providers (attending, fellow, and resident physicians, advanced practice providers including nurse practitioners and physician assistants) at each UCH (UC Health) site writing a discharge opioid prescription are eligible to receive the intervention.
Secondary subjects:
• Adult surgical inpatients age 18 and older within the UCHealth system at 4 different hospitals including UCH Metro, UCH Memorial Central, Medical Center of the Rockies, and Poudre Valley Hospital.
Exclusion Criteria
• None
Secondary subjects:
• Less than 18 years of age.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Nebraska
OTHER
Agency for Healthcare Research and Quality (AHRQ)
FED
University of Colorado, Denver
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karsten Bartels, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Colorado
Aurora, Colorado, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.
Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
19-3095
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.