Division of General Internal Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Harvard Medical School, Boston, Massachusetts.
JAMA Intern Med. 2024 May 1;184(5):484-492. doi: 10.1001/jamainternmed.2023.8315.
Chronic kidney disease (CKD) affects 37 million adults in the United States, and for patients with CKD, hypertension is a key risk factor for adverse outcomes, such as kidney failure, cardiovascular events, and death.
To evaluate a computerized clinical decision support (CDS) system for the management of uncontrolled hypertension in patients with CKD.
DESIGN, SETTING, AND PARTICIPANTS: This multiclinic, randomized clinical trial randomized primary care practitioners (PCPs) at a primary care network, including 15 hospital-based, ambulatory, and community health center-based clinics, through a stratified, matched-pair randomization approach February 2021 to February 2022. All adult patients with a visit to a PCP in the last 2 years were eligible and those with evidence of CKD and hypertension were included.
The intervention consisted of a CDS system based on behavioral economic principles and human-centered design methods that delivered tailored, evidence-based recommendations, including initiation or titration of renin-angiotensin-aldosterone system inhibitors. The patients in the control group received usual care from PCPs with the CDS system operating in silent mode.
The primary outcome was the change in mean systolic blood pressure (SBP) between baseline and 180 days compared between groups. The primary analysis was a repeated measures linear mixed model, using SBP at baseline, 90 days, and 180 days in an intention-to-treat repeated measures model to account for missing data. Secondary outcomes included blood pressure (BP) control and outcomes such as percentage of patients who received an action that aligned with the CDS recommendations.
The study included 174 PCPs and 2026 patients (mean [SD] age, 75.3 [0.3] years; 1223 [60.4%] female; mean [SD] SBP at baseline, 154.0 [14.3] mm Hg), with 87 PCPs and 1029 patients randomized to the intervention and 87 PCPs and 997 patients randomized to usual care. Overall, 1714 patients (84.6%) were treated for hypertension at baseline. There were 1623 patients (80.1%) with an SBP measurement at 180 days. From the linear mixed model, there was a statistically significant difference in mean SBP change in the intervention group compared with the usual care group (change, -14.6 [95% CI, -13.1 to -16.0] mm Hg vs -11.7 [-10.2 to -13.1] mm Hg; P = .005). There was no difference in the percentage of patients who achieved BP control in the intervention group compared with the control group (50.4% [95% CI, 46.5% to 54.3%] vs 47.1% [95% CI, 43.3% to 51.0%]). More patients received an action aligned with the CDS recommendations in the intervention group than in the usual care group (49.9% [95% CI, 45.1% to 54.8%] vs 34.6% [95% CI, 29.8% to 39.4%]; P < .001).
These findings suggest that implementing this computerized CDS system could lead to improved management of uncontrolled hypertension and potentially improved clinical outcomes at the population level for patients with CKD.
ClinicalTrials.gov Identifier: NCT03679247.
慢性肾脏病(CKD)影响了美国 3700 万成年人,对于 CKD 患者来说,高血压是导致不良结局的关键风险因素,如肾衰竭、心血管事件和死亡。
评估一种用于管理 CKD 患者未控制高血压的计算机化临床决策支持(CDS)系统。
设计、地点和参与者:这是一项多诊所、随机临床试验,通过分层、配对随机化方法,在包括 15 家医院、门诊和社区卫生中心的初级保健网络中对初级保健医生(PCP)进行随机分组,时间为 2021 年 2 月至 2022 年 2 月。所有在过去 2 年内有 PCP 就诊的成年患者均符合条件,且有 CKD 和高血压证据的患者也被纳入。
干预措施包括基于行为经济学原理和以人为中心的设计方法的 CDS 系统,该系统提供定制的、基于证据的建议,包括启动或调整肾素-血管紧张素-醛固酮系统抑制剂。对照组患者接受 PCP 的常规护理,CDS 系统以静默模式运行。
主要结果是与对照组相比,基线至 180 天的平均收缩压(SBP)变化。主要分析采用重复测量线性混合模型,在意向治疗重复测量模型中使用基线、90 天和 180 天的 SBP,以处理缺失数据。次要结果包括血压(BP)控制和患者接受与 CDS 建议一致的治疗的百分比等结果。
研究纳入了 174 名 PCP 和 2026 名患者(平均[标准差]年龄,75.3[0.3]岁;1223[60.4%]名女性;基线平均[标准差]SBP,154.0[14.3]mmHg),87 名 PCP 和 1029 名患者随机分入干预组,87 名 PCP 和 997 名患者随机分入常规护理组。总体而言,基线时有 1714 名(84.6%)患者接受高血压治疗。有 1623 名(80.1%)患者在 180 天时有 SBP 测量值。从线性混合模型来看,干预组与常规护理组的 SBP 变化均值差异具有统计学意义(变化,-14.6[95%CI,-13.1 至-16.0]mmHg 比-11.7[-10.2 至-13.1]mmHg;P=0.005)。与常规护理组相比,干预组血压控制达到目标的患者比例无差异(50.4%[95%CI,46.5%至 54.3%]比 47.1%[95%CI,43.3%至 51.0%])。与常规护理组相比,干预组更多的患者接受了与 CDS 建议一致的治疗(49.9%[95%CI,45.1%至 54.8%]比 34.6%[95%CI,29.8%至 39.4%];P<0.001)。
这些发现表明,实施这种计算机化的 CDS 系统可能会改善 CKD 患者未控制高血压的管理,并可能改善人群层面的临床结局。
ClinicalTrials.gov 标识符:NCT03679247。