Opioid-use DisorderPRINCENCT04601493
PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
A study testing Choice Architecture Nudge and PMP Integration & Nudge in people with Opioid-use Disorder and Opioid Use, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid-use Disorder, Opioid Use, Opioid Abuse
- What is being tested?
- Choice Architecture Nudge and PMP Integration & Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 1 Oct 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Who cannot join
- Primary care providers who work less than 20% full time equivalent (FTE)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.
Read the detailed description
To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.
The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.
- Conditions
- Opioid-use Disorder, Opioid Use, Opioid Abuse
- Being tested
- Choice Architecture Nudge, PMP Integration & Nudge
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choice Architecture NudgeBehavioural
During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic).
PMP Integration & NudgeBehavioural
During the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
| Study group | Role | What they receive |
|---|---|---|
| Care as Usual | No intervention | Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. |
| Choice Architecture Nudge | Experimental | Clinics in this arm will receive the choice architecture nudge intervention. Receives: Behavioral: Choice Architecture Nudge |
| PMP Integration & Nudge | Experimental | Clinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention. Receives: Behavioral: PMP Integration & Nudge |
| Choice Architecture Nudge + PMP Integration & Nudge | Experimental | Clinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions. Receives: Behavioral: Choice Architecture Nudge; Behavioral: PMP Integration & Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Prescription Rate
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
Measured: 12 months
Secondary outcomes (3)
Rate of Non-Opioid Treatment Prescription
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which a CDC-recommended non-opioid treatment in ordered
Measured: 12 months
Opioid Prescription Length
Outcome reported as the mean length of opioid prescription (in days) given during Primary Care Appointments
Measured: 12 months
Opioid Prescription MME
Outcome reported as the mean Milligram Morphine Equivalents (MME) of opioid prescriptions given during Primary Care Appointments
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start26 Aug 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 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.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 43 Primary Care Clinics will be randomized to be in one of 4 arms: 1) Care as usual, 2) Choice architecture nudge, 3) Prescription Drug Monitoring Program (PMP) Integration \& nudge, 4) Choice architecture nudge + PMP Integration \& nudge
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ezra Golberstein, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601493
- Sponsor's protocol ID
- STUDY00006522-2
- Other IDs
- R33DA046084
- Acronym
- PRINCE
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2020
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRescribing INterventions for Chronic Pain Via the Electronic Health Record Study - Opioid-Naive Population
- ClinicalTrials.gov ID
- NCT04601493
- Acronym / sponsor ID
- PRINCE / STUDY00006522-2
- Conditions
- Opioid-use Disorder, Opioid Use, Opioid Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to assess the effects of electronic health record (EHR)-based decision support tools on primary care provider (PCP) decision-making around pain treatment and opioid prescribing. The decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.
Detailed description
To test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of Fairview Medical Group and University of Minnesota Physicians.
The study has two parallel components. The decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. Four sets of analyses will be conducted separately: one for the opioid-naïve group using EHR data, one for the current opioid-user group using EHR data, one at the PCP-level using web survey data, and one at the PCP-level using MN Prescription Drug Monitoring Program (PDMP) data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 43 Primary Care Clinics will be randomized to be in one of 4 arms: 1) Care as usual, 2) Choice architecture nudge, 3) Prescription Drug Monitoring Program (PMP) Integration \& nudge, 4) Choice architecture nudge + PMP Integration \& nudge
| Arm | Type | Receives |
|---|---|---|
| Care as Usual | No intervention | –Clinics assigned to this arm will continue to care for the patients as usual in regards to opioid prescribing. |
| Choice Architecture Nudge | Experimental | Behavioral: Choice Architecture NudgeClinics in this arm will receive the choice architecture nudge intervention. |
| PMP Integration & Nudge | Experimental | Behavioral: PMP Integration & NudgeClinics in this arm will receive the Prescription Drug Monitoring (PMP) Integration \& Nudge intervention. |
| Choice Architecture Nudge + PMP Integration & Nudge | Experimental | Behavioral: Choice Architecture Nudge, Behavioral: PMP Integration & NudgeClinics in this arm will receive both the choice architecture nudge and prescription drug monitoring (PMP) integration \& nudge interventions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All primary care providers from all of the Fairview and University of Minnesota Physicians study clinics
Key exclusion criteria (1 listed)
- Primary care providers who work less than 20% full time equivalent (FTE)
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 |
|---|---|---|
| Choice Architecture NudgeDuring the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the "SmartSet" to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic). | Behavioural | Choice Architecture Nudge, Choice Architecture Nudge + PMP Integration & Nudge |
| PMP Integration & NudgeDuring the Prescription Drug Monitoring Program (PMP) integration \& nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient. | Behavioural | Choice Architecture Nudge + PMP Integration & Nudge, PMP Integration & Nudge |
Primary outcome
Opioid Prescription Rate
Time frame: 12 months
Outcome reported as the percent of Primary Care Appointments (PCAs) at each clinic during which an opioid is prescribed, without currently receiving a non-opioid alternative pain treatment (including a new order for a non-opioid pain treatment).
3 secondary outcomes
Rate of Non-Opioid Treatment Prescription
Time frame: 12 months
Opioid Prescription Length
Time frame: 12 months
Opioid Prescription MME
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ezra Golberstein, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choice Architecture Nudge and PMP Integration & Nudge in people with Opioid-use Disorder and Opioid Use, run by University of Minnesota 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 26 Aug 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 26 Aug 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?
Opioid Prescription Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2024.