Opioid UseNCT04446975
Best Practice Alert for Opioid Prescribing
A study testing BPA in people with Opioid Use, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- BPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,689 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary subjects:
- 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.
Who cannot join
- Primary subjects:
- None
- Secondary subjects:
- Less than 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Best Practice Alert for Post-Surgical Opioid Prescribing At Discharge
The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial.
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).
Read the detailed description
Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this aim is to prescribe pain medications after surgery in a patient-centered fashion. The investigators have used the average amount of opioid medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated "prior to discharge daily MME dose" will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be displayed when the electronic order entry for the post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In addition, the provider will be prompted to also prescribe non-opioid analgesic medications. This BPA was developed by the Principal Investigator under guidance of the UCHealth System Multidisciplinary Opioid/Pain Management Committee as well as published guidelines.
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
- Opioid Use
- Being tested
- BPA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| BPA Off | No intervention | No best-practice alert (BPA) message is displayed to providers. |
| BPA On | Experimental | BPA message is displayed to providers based on patient opioid intake as reported in the electronic health record (EHR). Receives: Other: BPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids Prescribed at Discharge
Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record
Measured: 1 day, on discharge date from hospital
Secondary outcomes (2)
Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge
Number of Participants prescribed discharge non-opioid analgesic medications (opioid/non-opioid combination formulations) as recorded in the electronic health record
Measured: 1 day, on discharge date from hospital
Number of Participants With Opioid Prescriptions After Discharge
Number of participants with opioid prescriptions after discharge as recorded in the electronic health record
Measured: "Day of discharge +1" until 28 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start7 Jul 2020
- Primary completion8 Jun 2021
- Study completion8 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This trial will be designed using a stepped wedge design with randomization occurring based on timing and location of enrollment according to PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) to maximize applicability. The BPA will be turned "OFF" vs. "ON" in the participating hospitals according to each 8-week study interval. OFF and ON periods will be separated by 4-week washout intervals. An 8-week period prior to study start will provide baseline trends in prescription patterns. 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21,689 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Karsten Bartels, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446975
- Sponsor's protocol ID
- 19-3095
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2020
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26824844Loudon 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.
PubMed 25956159Bartels 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.
PubMed 29627407Chen 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.
PubMed 29238810
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Practice Alert for Post-Surgical Opioid Prescribing At Discharge
- ClinicalTrials.gov ID
- NCT04446975
- Acronym / sponsor ID
- 19-3095
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,689 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Nebraska, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 8 Jun 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 4 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial.
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).
Detailed description
Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this aim is to prescribe pain medications after surgery in a patient-centered fashion. The investigators have used the average amount of opioid medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated "prior to discharge daily MME dose" will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be displayed when the electronic order entry for the post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In addition, the provider will be prompted to also prescribe non-opioid analgesic medications. This BPA was developed by the Principal Investigator under guidance of the UCHealth System Multidisciplinary Opioid/Pain Management Committee as well as published guidelines.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This trial will be designed using a stepped wedge design with randomization occurring based on timing and location of enrollment according to PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) to maximize applicability. The BPA will be turned "OFF" vs. "ON" in the participating hospitals according to each 8-week study interval. OFF and ON periods will be separated by 4-week washout intervals. An 8-week period prior to study start will provide baseline trends in prescription patterns. 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.
| Arm | Type | Receives |
|---|---|---|
| BPA Off | No intervention | –No best-practice alert (BPA) message is displayed to providers. |
| BPA On | Experimental | Other: BPABPA message is displayed to providers based on patient opioid intake as reported in the electronic health record (EHR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (4 listed)
- None
- Less than 18 years of age.
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 |
|---|---|---|
| BPAAt 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. | Other | BPA On |
Primary outcome
Opioids Prescribed at Discharge
Time frame: 1 day, on discharge date from hospital
Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record
2 secondary outcomes
Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge
Time frame: 1 day, on discharge date from hospital
Number of Participants With Opioid Prescriptions After Discharge
Time frame: "Day of discharge +1" until 28 days after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26824844Bartels 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.
- Background: PubMed 25956159Loudon 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.
- Background: PubMed 29627407Bartels 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.
- Background: PubMed 29238810Chen 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.
- Individual participant dataSharing planned: No
Related trials for Opioid Use
Not yet recruiting
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
ACL, Opioid Use
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Active, not recruitingPhase 1/2
Sublingual Dexmedetomidine for Treating Opioid Withdrawal
Opioid Use Disorder, Opioid Withdrawal
Not yet recruitingPhase 4
Examining Analgesic Synergy and Efficacy in Trauma Care
Opioid Use Disorder
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
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.
Karsten Bartels, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPA in people with Opioid Use, run by University of Colorado, Denver 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 4 inclusion and 4 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 4 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 4 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioids Prescribed at Discharge (time frame: 1 day, on discharge date from hospital). 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 NCT04446975, which also lists 4 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 4 Mar 2024.