An interventional study of Clinician Nudge and Patient Nudge in Cardiovascular Diseases, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research
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.
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 4,131 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Control arm will receive no intervention.
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.
Behavioral: Clinician Nudge
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.
Behavioral: Patient Nudge
The clinician nudge and patient nudge will be implemented.
Behavioral: Clinician Nudge · Behavioral: Patient Nudge
Active choice intervention in the electronic health record and peer comparison messaging on performance
Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
Statin Prescribing
Change in percent of patients prescribed a statin medication.
Time frame: 6 months
Plan to share: 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.
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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