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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,131
- 试验地点
- 1
- 主要终点
- Statin Prescribing
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators, statisticians, and analysts will be blinded during the intervention and analysis. Study staff (project director, manager, and research coordinators) will be unblinded throughout the study in order to deliver the appropriate interventions and to manage participant communications. The project manager will be tasked with maintaining codes to associate the blinded assignments to the clinical practices.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
- •Currently breastfeeding
- •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.
研究组 & 干预措施
Control
Control arm will receive no intervention.
Clinician nudge
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.
干预措施: Clinician Nudge (Behavioral)
Patient 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.
干预措施: Patient Nudge (Behavioral)
Clinician Nudge and Patient Nudge
The clinician nudge and patient nudge will be implemented.
干预措施: Clinician Nudge (Behavioral)
Clinician Nudge and Patient Nudge
The clinician nudge and patient nudge will be implemented.
干预措施: Patient Nudge (Behavioral)
结局指标
主要结局
Statin Prescribing
时间窗: 6 months
Change in percent of patients prescribed a statin medication.
次要结局
未报告次要终点