Fanaroff Alexander C, Huang Qian, Clark Kayla, Norton Laurie A, Kellum Wendell E, Eichelberger Dwight, Wood John C, Bricker Zachary, Dooley Wood Andrea G, Kemmer Greta, Smith Jennifer I, Adusumalli Srinath, Putt Mary E, Volpp Kevin G
Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia.
Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia.
JAMA Cardiol. 2025 May 1;10(5):473-481. doi: 10.1001/jamacardio.2025.0244.
Despite statins' benefit in preventing major adverse cardiovascular events, most patients with an indication for statin therapy are not appropriately treated. Clinicians' limited time and lack of systematic efforts to address preventive care likely contribute to gaps in statin prescribing.
To determine the effect on statin prescribing of 2 interventions to refer appropriate patients to a pharmacist for lipid management.
DESIGN, SETTING, AND PARTICIPANTS: These 2 pragmatic cluster randomized clinical trials were conducted among 12 total primary care practices in a community health system. Trial 1 was a delayed-intervention design of a visit-based intervention with randomization at the clinician level in a single clinic, and trial 2 was a parallel-arm trial of an asynchronous intervention with randomization at the clinic level in 11 clinics. Patients who were assigned to a primary care clinician at a participating practice, had an indication for a high-intensity or moderate-intensity statin, and were either not prescribed a statin or prescribed an inappropriately low statin dose were eligible for inclusion.
Trial 1 tested an interruptive electronic health record alert that appeared during eligible patients' visits and facilitated referral to a pharmacist, while trial 2 tested an order for pharmacist referral placed by the study team for cosignature by the primary care clinician without regard to the timing of a clinic visit.
The primary outcome was the proportion of patients prescribed a statin.
Overall, 1412 patients were enrolled in trial 1 and 1950 in trial 2. Across both trials, mean (SD) patient age was 65.6 (9.9) years, and 1485 patients (44.2%) were female. Mean (SD) baseline 10-year risk of major cardiovascular events was 17.9% (9.4). In trial 1, the interruptive alert was not associated with a significant increase in statin prescriptions compared with usual care (15.6% vs 11.6%; unadjusted absolute difference, 3.9 percentage points; 95% CI, -0.4 to 8.3). In trial 2, semiautomated pharmacist referrals were associated with an increase in statin prescriptions by 16 percentage points compared with usual care (31.6% vs 15.2%; unadjusted absolute difference, 16.4 percentage points; 95% CI, 12.7-20.1).
In these 2 cluster randomized clinical trials, visit-based interruptive alerts were not associated with a significant increase in statin prescribing compared with usual care, whereas a strategy of asynchronous semiautomated referral for pharmacist comanagement was associated with a substantial increase. This strategy of asynchronous semiautomated referrals for pharmacist involvement in lipid management could be a scalable and effective approach to increasing statin prescribing for patients at high risk.
ClinicalTrials.gov Identifier: NCT05537064.
尽管他汀类药物在预防主要不良心血管事件方面有益,但大多数有他汀类药物治疗指征的患者未得到适当治疗。临床医生时间有限且缺乏系统的预防保健工作,这可能导致他汀类药物处方存在差距。
确定将合适患者转介给药剂师进行血脂管理的两种干预措施对他汀类药物处方的影响。
设计、设置和参与者:这两项实用的整群随机临床试验在一个社区卫生系统的12个基层医疗诊所中进行。试验1是一项基于就诊的干预措施的延迟干预设计,在单个诊所的临床医生层面进行随机分组;试验2是一项异步干预的平行组试验,在11个诊所的诊所层面进行随机分组。在参与试验的诊所中被分配给基层医疗临床医生、有高强度或中等强度他汀类药物治疗指征、未开具他汀类药物或开具的他汀类药物剂量过低的患者符合纳入标准。
试验1测试了一种在符合条件的患者就诊期间出现的干扰性电子健康记录警报,并促进转介给药剂师;试验2测试了研究团队下达的药剂师转介医嘱,由基层医疗临床医生共同签署,而不考虑就诊时间。
主要结局是开具他汀类药物的患者比例。
总体而言,试验1招募了1412名患者,试验2招募了1950名患者。在两项试验中,患者的平均(标准差)年龄为65.6(9.9)岁,1485名患者(44.2%)为女性。主要心血管事件的平均(标准差)基线10年风险为17.9%(9.4)。在试验1中,与常规护理相比,干扰性警报与他汀类药物处方的显著增加无关(15.6%对11.6%;未调整的绝对差异为3.9个百分点;95%置信区间为-0.4至8.3)。在试验2中,与常规护理相比,半自动药剂师转介使他汀类药物处方增加了16个百分点(31.6%对15.2%;未调整的绝对差异为16.4个百分点;95%置信区间为12.7-20.1)。
在这两项整群随机临床试验中,与常规护理相比,基于就诊的干扰性警报与他汀类药物处方的显著增加无关,而异步半自动转介给药剂师共同管理的策略则与大幅增加相关。这种让药剂师参与血脂管理的异步半自动转介策略可能是一种可扩展且有效的方法,可增加高危患者的他汀类药物处方量。
ClinicalTrials.gov标识符:NCT05537064。