Cardiovascular DiseasesNCT03271931
Active Choice in the EHR to Promote Statin Therapy
A study testing Active choice and Passive choice in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
Trial summary
Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Active choice and Passive choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23,066 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2018to 5 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a cardiologist at the University of Pennsylvania Health System
- Meets 2013 ACC/AHA or NLA guidelines for statin prescription
Who cannot join
- Allergy to statins
- Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
- Adverse reaction to statins including a) myopathy, b)rhabdomyolysis, c)hepatitis
- Pregnant
- On a PCSK9 Inhibitor medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy
Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.
Read the detailed description
This study will use a randomized, controlled trial to evaluate a health system initiative. Cardiologists randomly assigned to the control arm will receive no interventions. For cardiologists randomly assigned to the active choice intervention, the electronic health record will be used to prompt cardiologists to initiate or change statin therapy for patients not on evidenced-based guidelines based on the 2013 American College of Cardiology / American Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice alert" in Epic which appears on the screen and forces a decision before the clinician can move on. For cardiologists randomly assigned to the passive choice intervention, the electronic health record will be used to create a passive alert using the same evidence-based guidelines. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. The intervention period will be 6 months in duration.
- Conditions
- Cardiovascular Diseases
- Being tested
- Active choice, Passive choice
- 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
EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.
Passive choiceBehavioural
EHR passive alert to cardiologists about prescribing a statin
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Cardiologists in this arm will receive no interventions and will act as usual care |
| Active choice | Experimental | Cardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not. Receives: Behavioral: Active choice |
| Passive choice | Experimental | Cardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. Receives: Behavioral: Passive choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines
Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.
Measured: 6 Months
Secondary outcomes (1)
Change in percentage of eligible patients prescribed a statin, at any dose.
Among patients not on a statin, the percent that are prescribed guideline-based therapy, at any dose.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start24 Sep 2018
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 23,066 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
- NCT03271931
- Sponsor's protocol ID
- 827983
- Status last verified
- Jul 2019
- First submitted
- 1 Sep 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adusumalli S, Westover JE, Jacoby DS, Small DS, VanZandbergen C, Chen J, Cavella AM, Pepe R, Rareshide CAL, Snider CK, Volpp KG, Asch DA, Patel MS. Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):40-48. doi: 10.1001/jamacardio.2020.4730.
PubMed 33031534
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Active Choice in the EHR to Promote Cardiologists to Prescribe Evidence-Based Statin Therapy
- ClinicalTrials.gov ID
- NCT03271931
- Acronym / sponsor ID
- 827983
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23,066 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 5 Sep 2017 (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.
Cardiovascular (CV) events are the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing CV events and mortality, but statins are often either not prescribed or under-prescribed for patients that meet evidence-based guidelines. In this study, we will evaluate a health system initiative using active and passive choice prompts in the electronic health record to prompt cardiologists to prescribe evidence-based statin therapy. In partnership with the health system, this will be conducted as a randomized, controlled trial to evaluate its effect.
Detailed description
This study will use a randomized, controlled trial to evaluate a health system initiative. Cardiologists randomly assigned to the control arm will receive no interventions. For cardiologists randomly assigned to the active choice intervention, the electronic health record will be used to prompt cardiologists to initiate or change statin therapy for patients not on evidenced-based guidelines based on the 2013 American College of Cardiology / American Heart Association (ACC/AHA) and the National Lipid Association (NLA) through a "best practice alert" in Epic which appears on the screen and forces a decision before the clinician can move on. For cardiologists randomly assigned to the passive choice intervention, the electronic health record will be used to create a passive alert using the same evidence-based guidelines. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. The intervention period will be 6 months in duration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Cardiologists in this arm will receive no interventions and will act as usual care |
| Active choice | Experimental | Behavioral: Active choiceCardiologists in this arm will be exposed to an active choice intervention through the electronic health record (EHR) using an alert to prompt recommendations for statin therapy for patients not on guideline-based therapy. Cardiologists will be have to make an active choice to prescribe a statin at the recommended dose or not. |
| Passive choice | Experimental | Behavioral: Passive choiceCardiologists in this arm will be exposed to a passive choice alert within the EHR, using the same evidence-based guidelines as in the active choice arm. The passive alert will not block clinician workflow and instead will be available in the background for the cardiologist to open and then use to make a prescribing decision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a cardiologist at the University of Pennsylvania Health System
- Meets 2013 ACC/AHA or NLA guidelines for statin prescription
Key exclusion criteria (5 listed)
- Allergy to statins
- Severe renal insufficiency defined as glomerular filtration rate (GFR) less than 30 mL/min or on dialysis
- Adverse reaction to statins including a) myopathy, b)rhabdomyolysis, c)hepatitis
- Pregnant
- On a PCSK9 Inhibitor medication
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 choiceEHR alert prompting cardiologists to make an active choice to prescribe a statin or not. | Behavioural | Active choice |
| Passive choiceEHR passive alert to cardiologists about prescribing a statin | Behavioural | Passive choice |
Primary outcome
Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines
Time frame: 6 Months
Among patients not on guideline-based statin dosages, the percent that are prescribed guideline-based therapy at appropriate dose.
1 secondary outcome
Change in percentage of eligible patients prescribed a statin, at any dose.
Time frame: 6 Months
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 16 Jul 2019.
- Derived from this study: PubMed 33031534Adusumalli S, Westover JE, Jacoby DS, Small DS, VanZandbergen C, Chen J, Cavella AM, Pepe R, Rareshide CAL, Snider CK, Volpp KG, Asch DA, Patel MS. Effect of Passive Choice and Active Choice Interventions in the Electronic Health Record to Cardiologists on Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2021 Jan 1;6(1):40-48. doi: 10.1001/jamacardio.2020.4730.
- 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.
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 Passive choice 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 5 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 16 Jul 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?
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?
Change in the percent of eligible patients prescribed statin therapy at a dose that meets evidence-based guidelines (time frame: 6 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 NCT03271931, 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 16 Jul 2019.