QURE Healthcare, 1720 S Bellaire Street, Suite 1250, Denver, CO, 80222, USA.
Wayne State University School of Medicine, Detroit, MI, USA.
BMC Med. 2024 Nov 18;22(1):540. doi: 10.1186/s12916-024-03757-6.
Clinical management of patients with chronic cardiometabolic disease is complicated by polypharmacy. Consequently, when patients clinically deteriorate, physicians are challenged to distinguish both medication nonadherence and drug-drug interactions (DDI) from chronic disease progression.
In this randomized controlled trial, we enrolled U.S. board-certified Primary Care Physicians (PCPs) serving patients with cardiometabolic disease. PCPs were randomized and managed their patients with (intervention), or without (control), a novel chronic disease management test (CDMT) that can detect medication nonadherence and DDIs. Patients' medical records were abstracted at baseline and 3-month follow-up. Primary outcomes were the CDMT's impact on both the PCPs' detection of medication nonadherence and DDI, and the frequency of performing medication nonadherence- and DDI-related clinical actions. Secondary outcomes examined the types of clinical actions performed. Primary and secondary outcomes were analyzed by logistic regression using single variable and clustered multivariable modeling to adjust for similarities in patient characteristics, by PCP practice.
Sixteen intervention and 20 control PCPs shared de-identified records for 126 and 207 patients, respectively. There were no significant demographic differences between the two study arms, among PCPs or patients. At baseline, there was no significant difference between the intervention and control PCPs in the percentage of clinical actions performed for medication nonadherence (P = 0.98) and DDI (P = 0.41). At 3-month follow-up (after CDMT), 69.1% of intervention compared to 20.3% of control patients with medication nonadherence had a related clinical action performed (P < 0.001). Regarding DDI, 37.3% of intervention compared to 0.5% of control patients had a relevant clinical action performed in follow-up (P < 0.001). Across the range of medication nonadherence- and DDI-related actions, the intervention compared to the control PCPs were more likely to adjust the medication regimen (24.1% vs. 9.5%) and document medication nonadherence in the patient chart (31.0% vs. 14.3%) at follow-up (P = 0.04).
Although intervention and control PCPs similarly detected and acted upon medication nonadherence and DDI at baseline, intervention PCPs' detection increased significantly after using the CDMT. Also, the clinical actions performed with CDMT support were more clinically rigorous. These outcomes support the clinical utility of CDMT in the management of symptomatic patients with cardiometabolic disease and polypharmacy.
患有慢性心脏代谢疾病的患者的临床管理因多种药物治疗而变得复杂。因此，当患者临床状况恶化时，医生面临着区分药物依从性不良和药物-药物相互作用（DDI）与慢性疾病进展的挑战。
在这项随机对照试验中，我们招募了服务于心脏代谢疾病患者的美国 board 认证的初级保健医生（PCP）。PCP 被随机分为干预组和对照组，分别使用（干预）和不使用（对照）一种新的慢性疾病管理测试（CDMT），该测试可以检测药物依从性不良和 DDI。在基线和 3 个月随访时，对患者的病历进行了摘录。主要结局是 CDMT 对 PCP 检测药物依从性不良和 DDI 的影响，以及执行药物依从性和 DDI 相关临床操作的频率。次要结局检查了执行的临床操作类型。使用单变量和聚类多变量模型对主要和次要结局进行分析，以调整患者特征和 PCP 实践的相似性。
16 名干预组和 20 名对照组的 PCP 分别为 126 名和 207 名患者共享去识别记录。两组之间的患者和 PCP 的人口统计学特征没有显著差异。在基线时，干预组和对照组的 PCP 在药物依从性不良（P=0.98）和 DDI（P=0.41）方面执行临床操作的百分比没有显著差异。在 3 个月随访（使用 CDMT 后），与对照组相比，69.1%的干预组药物依从性不良患者进行了相关临床操作（P<0.001）。在 DDI 方面，与对照组相比，37.3%的干预组患者在随访中进行了相关的临床操作（P<0.001）。在药物依从性和 DDI 相关操作的范围内，与对照组相比，干预组更有可能调整药物治疗方案（24.1% vs. 9.5%）并在患者图表中记录药物依从性（31.0% vs. 14.3%）（P=0.04）。
尽管干预组和对照组的 PCP 在基线时同样检测和处理了药物依从性不良和 DDI，但使用 CDMT 后，干预组的检测明显增加。此外，使用 CDMT 支持的临床操作更加严格。这些结果支持 CDMT 在管理患有心脏代谢疾病和多种药物治疗的有症状患者中的临床效用。
