Cardiovascular DiseasesPRESCRIBENCT03021759
Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
A study testing Active choice and Social comparison feedback in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Active choice and Social comparison feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,774 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 21 Apr 2017
- 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 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient has a primary care physician at University of Pennsylvania Health System
- Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record
Who cannot join
- Patient has an allergy or adverse reaction to statins documented in the electronic health record
- Patient has glomerular filtration rate less than 30 mL/min
- Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.
- Conditions
- Cardiovascular Diseases
- Being tested
- Active choice, Social comparison feedback
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active choiceBehavioural
Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin
Social comparison feedbackBehavioural
Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Active choice | Experimental | Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Receives: Behavioral: Active choice |
| Active choice with social comparison feedback | Experimental | Physicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers Receives: Behavioral: Active choice; Behavioral: Social comparison feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin Prescribing Rate
Percentage of patients eligible for a statin that have been prescribed a statin
Measured: Two Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start21 Feb 2017
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021759
- Sponsor's protocol ID
- 826125
- Acronym
- PRESCRIBE
- Status last verified
- Mar 2019
- First submitted
- 12 Jan 2017
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.
PubMed 30646039
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic, Randomized Evaluation of Statin Active Choice to Reach Improved Outcomes Based on Evidence
- ClinicalTrials.gov ID
- NCT03021759
- Acronym / sponsor ID
- PRESCRIBE / 826125
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,774 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 16 Jan 2017 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will conduct a pragmatic, cluster-randomized, controlled trial to evaluate an active choice intervention with and without social comparison feedback to increase physician statin prescribing rates for eligible patients.
Detailed description
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Strong evidence indicates that statin medications can reduce the risk of CVD and for those with CVD statins have been shown to reduce mortality. Despite this evidence, statins are under-prescribed. In this study, the investigators will test the effectiveness of nudges targeted to physicians using active choice and social comparisons feedback to increasing the rate at which statin medications are prescribed to patients eligible based on national practice guidelines.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Active choice | Experimental | Behavioral: Active choicePhysicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. |
| Active choice with social comparison feedback | Experimental | Behavioral: Active choice, Behavioral: Social comparison feedbackPhysicians will be asked to review a list of their patients eligible for statin therapy who are not yet prescribed a statin and make an active choice whether or not to prescribe a statin. Physicians will receive social comparison feedback informing them of how their performance compares to their peers |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has a primary care physician at University of Pennsylvania Health System
- Patient meets 2013 AHA/ACC guidelines for statin therapy but no record of a statin prescription in the electronic health record
Key exclusion criteria (3 listed)
- Patient has an allergy or adverse reaction to statins documented in the electronic health record
- Patient has glomerular filtration rate less than 30 mL/min
- Physicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin
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 |
|---|---|---|
| Active choiceStatin options are framed to physicians as an active choice to prescribe or not prescribe a statin | Behavioural | Active choice, Active choice with social comparison feedback |
| Social comparison feedbackStatin prescribing rates are communicated to physicians and along with how their performance compares to their peers | Behavioural | Active choice with social comparison feedback |
Primary outcome
Statin Prescribing Rate
Time frame: Two Months
Percentage of patients eligible for a statin that have been prescribed a statin
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30646039Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, Leri D, Rareshide CAL, Day SC, Mahoney KB, Volpp KG, Asch DA. Effect of an Automated Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Jul 6;1(3):e180818. doi: 10.1001/jamanetworkopen.2018.0818.
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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.
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active choice and Social comparison feedback in people with Cardiovascular Diseases, run by University of Pennsylvania 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 2 inclusion and 3 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 20 Jun 2019. 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 20 Jun 2019). 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?
Statin Prescribing Rate (time frame: Two Months). 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 NCT03021759, which also lists 1 linked publication.
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 20 Jun 2019.