Cardiovascular DiseasesNCT04307472
Nudges for Statin Prescribing in Primary Care
A study testing Clinician Nudge and Patient Nudge in people with Cardiovascular Diseases, run by University of Pennsylvania at 1 site in United States.
Trial summary
The objective of the study is to evaluate the effect of nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet national guidelines. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Clinician Nudge and Patient Nudge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,131 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 18 Apr 2021
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have new or return visit with a primary care provider at one of the study practices at the University of Pennsylvania Health System
- Either have an ASCVD condition, history of familial hyperlipidemia, or meet United State Preventive Task Force Guidelines for Statin Therapy which includes age 40-75 years, at least 1 cardiovascular risk factor (e.g. dyslipidemia, diabetes, hypertension, smoking), 10-year ASVCD risk score ≥ 10%
Who cannot join
- Already prescribed a statin
- 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 statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
- Pregnant
- Currently breastfeeding
Show all 9Show fewer
- on hospice or at the end-of-life
- On a PCSK9 Inhibitor medication
- Clinicians (and their respective patients) will be excluded if they have less than 10 patients among their entire panel that are eligible for a statin medication.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Leveraging the Electronic Health Record to Nudge Clinicians to Prescribe Evidence-Based Statin Medications to Reduce the Risk of Cardiovascular Disease: A Randomized Clinical Trial
The objective of the study is to evaluate the effect of nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet national guidelines.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing the risk of CVD-related events and mortality, but statins are often not prescribed for patients that meet evidence-based guidelines. In this study, the investigators will evaluate nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet the United States Preventive Task Force guidelines, patients with clinical atherosclerotic cardiovascular disease (ASCVD) condition, and patients with a history of familial hyperlipidemia. In partnership with the health system, this will be conducted as a 4-arm factorial, cluster randomized trial to evaluate the effect of the interventions.
- Conditions
- Cardiovascular Diseases
- Being tested
- Clinician Nudge, Patient Nudge
- Keywords
- Statin
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician NudgeBehavioural
Active choice intervention in the electronic health record and peer comparison messaging on performance
Patient NudgeBehavioural
Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control arm will receive no intervention. |
| Clinician nudge | Experimental | The clinician nudge using an active choice intervention in the electronic health record will be delivered to the clinician during the patient's visit. This will be through a Best Practice Advisory that describes the guideline criteria for which the patient is eligible for statin therapy, provides pre-selected options for a statin with alternative options.
The clinician nudge using monthly peer comparison messages will be sent as an inbox message through the electronic health record. Clinicians will be told what percent of their eligible patients have been prescribed a statin and how that compares to peer clinicians at Penn Medicine. Receives: Behavioral: Clinician Nudge |
| Patient nudge | Experimental | The patient nudge will be a text message. Patients with a visit scheduled with their primary care clinician will be identified and sent this text 72 hours before their scheduled visit. The text will remind them of the visit, inform them of their eligibility for a statin, describe the benefits and risks of statin therapy, and ask the patient to discuss statin therapy with their primary care clinician during the visit. Receives: Behavioral: Patient Nudge |
| Clinician Nudge and Patient Nudge | Experimental | The clinician nudge and patient nudge will be implemented. Receives: Behavioral: Clinician Nudge; Behavioral: Patient Nudge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin Prescribing
Change in percent of patients prescribed a statin medication.
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 posted13 Mar 2020
- Study start19 Oct 2020
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
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
- Factorial
- Model description
- The four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention: 1. Control 2. Clinician nudge using an active choice prompt in the electronic health record at the time of the patient visit and a monthly peer comparison message on statin prescribing performance relative to peer clinicians at Penn Medicine delivered through the electronic health record 3. Patient nudge using a text message sent 72 hours prior to their primary care clinician appointment that informs them of their eligibility for a statin, the risks and benefits, and asking them to discuss the role of starting a statin with their clinician 4. Both clinician nudge and patient nudges
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307472
- Sponsor's protocol ID
- 833396
- Other IDs
- 4R33AG057380-03
- Status last verified
- May 2021
- First submitted
- 10 Mar 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be submitted as an appendix to the main manuscript for publication in an academic journal. Changes to the electronic health record to implement the intervention will be described in the main study manuscript. If any coding is required, it will be made accessible to other researchers on Dataverse, an open source web application. After publication of the main findings, analytical codes used to process and analyze the data will be made available to other researchers on Dataverse, an open source web application.
Publications
Adusumalli S, Kanter GP, Small DS, Asch DA, Volpp KG, Park SH, Gitelman Y, Do D, Leri D, Rhodes C, VanZandbergen C, Howell JT, Epps M, Cavella AM, Wenger M, Harrington TO, Clark K, Westover JE, Snider CK, Patel MS. Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):23-30. doi: 10.1001/jamacardio.2022.4373.
PubMed 36449275
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging the Electronic Health Record to Nudge Clinicians to Prescribe Evidence-Based Statin Medications to Reduce the Risk of Cardiovascular Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04307472
- Acronym / sponsor ID
- 833396
- Conditions
- Cardiovascular Diseases
- Keywords
- Statin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,131 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 13 Mar 2020 (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.
The objective of the study is to evaluate the effect of nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet national guidelines.
Detailed description
Cardiovascular disease (CVD) is the leading cause of mortality in the United States. Statins have been demonstrated to be an effective tool for reducing the risk of CVD-related events and mortality, but statins are often not prescribed for patients that meet evidence-based guidelines. In this study, the investigators will evaluate nudges to clinicians, patients, or both to initiate statin prescriptions for patients that meet the United States Preventive Task Force guidelines, patients with clinical atherosclerotic cardiovascular disease (ASCVD) condition, and patients with a history of familial hyperlipidemia. In partnership with the health system, this will be conducted as a 4-arm factorial, cluster randomized trial to evaluate the effect of the interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The four-arm factorial trial will randomly assign primary care practices to one of the following arms for the intervention: 1. Control 2. Clinician nudge using an active choice prompt in the electronic health record at the time of the patient visit and a monthly peer comparison message on statin prescribing performance relative to peer clinicians at Penn Medicine delivered through the electronic health record 3. Patient nudge using a text message sent 72 hours prior to their primary care clinician appointment that informs them of their eligibility for a statin, the risks and benefits, and asking them to discuss the role of starting a statin with their clinician 4. Both clinician nudge and patient nudges
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control arm will receive no intervention. |
| Clinician nudge | Experimental | Behavioral: Clinician NudgeThe clinician nudge using an active choice intervention in the electronic health record will be delivered to the clinician during the patient's visit. This will be through a Best Practice Advisory that describes the guideline criteria for which the patient is eligible for statin therapy, provides pre-selected options for a statin with alternative options. The clinician nudge using monthly peer comparison messages will be sent as an inbox message through the electronic health record. Clinicians will be told what percent of their eligible patients have been prescribed a statin and how that compares to peer clinicians at Penn Medicine. |
| Patient nudge | Experimental | Behavioral: Patient NudgeThe patient nudge will be a text message. Patients with a visit scheduled with their primary care clinician will be identified and sent this text 72 hours before their scheduled visit. The text will remind them of the visit, inform them of their eligibility for a statin, describe the benefits and risks of statin therapy, and ask the patient to discuss statin therapy with their primary care clinician during the visit. |
| Clinician Nudge and Patient Nudge | Experimental | Behavioral: Clinician Nudge, Behavioral: Patient NudgeThe clinician nudge and patient nudge will be implemented. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have new or return visit with a primary care provider at one of the study practices at the University of Pennsylvania Health System
- Either have an ASCVD condition, history of familial hyperlipidemia, or meet United State Preventive Task Force Guidelines for Statin Therapy which includes age 40-75 years, at least 1 cardiovascular risk factor (e.g. dyslipidemia, diabetes, hypertension, smoking), 10-year ASVCD risk score ≥ 10%
Key exclusion criteria (9 listed)
- Already prescribed a statin
- 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 statin-related a) myopathy; b) Rhabdomyolysis; c) hepatitis
- Pregnant
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 |
|---|---|---|
| Clinician NudgeActive choice intervention in the electronic health record and peer comparison messaging on performance | Behavioural | Clinician Nudge and Patient Nudge, Clinician nudge |
| Patient NudgeText message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician | Behavioural | Clinician Nudge and Patient Nudge, Patient nudge |
Primary outcome
Statin Prescribing
Time frame: 6 months
Change in percent of patients prescribed a statin medication.
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 21 May 2021.
- Derived from this study: PubMed 36449275Adusumalli S, Kanter GP, Small DS, Asch DA, Volpp KG, Park SH, Gitelman Y, Do D, Leri D, Rhodes C, VanZandbergen C, Howell JT, Epps M, Cavella AM, Wenger M, Harrington TO, Clark K, Westover JE, Snider CK, Patel MS. Effect of Nudges to Clinicians, Patients, or Both to Increase Statin Prescribing: A Cluster Randomized Clinical Trial. JAMA Cardiol. 2023 Jan 1;8(1):23-30. doi: 10.1001/jamacardio.2022.4373.
- Individual participant dataSharing planned: Yes. The study protocol will be submitted as an appendix to the main manuscript for publication in an academic journal. Changes to the electronic health record to implement the intervention will be described in the main study manuscript. If any coding is required, it will be made accessible to other researchers on Dataverse, an open source web application. After publication of the main findings, analytical codes used to process and analyze the data will be made available to other researchers on Dataverse, an open source web application.
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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 Clinician Nudge and Patient Nudge 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 9 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 21 May 2021. 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?
Statin Prescribing (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 NCT04307472, 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 21 May 2021.