Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Center for Population Health Sciences, Duke University, Durham, NC; Division of General Internal Medicine, Duke University, Durham, NC; Departments of Psychiatry and School of Nursing, Duke University, Durham, NC.
Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC.
Am Heart J. 2018 May;199:122-129. doi: 10.1016/j.ahj.2018.02.002. Epub 2018 Feb 10.
Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction.
This is a 2-arm (clinical pharmacist specialist-delivered, telehealth intervention and education control) randomized controlled trial including Veterans with poorly controlled hypertension and/or hypercholesterolemia. Primary outcome was Framingham CVD risk score at 6 and 12 months, with systolic blood pressure; diastolic blood pressure; total cholesterol; low-density lipoprotein; high-density lipoprotein; body mass index; and, for those with diabetes, HbA1c as secondary outcomes.
Among 428 Veterans, 50% were African American, 85% were men, and 33% had limited health literacy. Relative to the education control group, the clinical pharmacist specialist-delivered intervention did not show a reduction in CVD risk score at 6 months (-1.8, 95% CI -3.9 to 0.3; P = .10) or 12 months (-0.3, 95% CI -2.4 to 1.7; P = .74). No differences were seen in systolic blood pressure, diastolic blood pressure, or low-density lipoprotein at 6 or 12 months. We did observe a significant decline in total cholesterol at 6 months (-7.0, 95% CI -13.4 to -0.6; P = .03) in the intervention relative to education control group. Among patients in the intervention group, 34% received at least 5 of the 12 planned intervention calls and were considered "compliers." A sensitivity analysis of the "complier average causal effect" of intervention compared to control showed a mean difference in CVD risk score reduction of 5.7 (95% CI -12.0 to 0.7) at 6 months and -1.7 (95% CI -7.6 to 4.8) at 12 months.
Despite increased access to pharmacist resources, we did not observe significant improvements in CVD risk for patients randomized to the intervention compared to education control over 12 months. However, the intervention may have positive impact among those who actively participate, particularly in the short term.
综合方案解决个性化患者自我管理和药物治疗问题，可能有助于降低心血管疾病（CVD）风险降低的障碍。
这是一项 2 臂（临床药师专家提供的远程医疗干预和教育对照组）随机对照试验，包括血压控制不佳的高血压和/或高胆固醇血症退伍军人。主要结果是 Framingham CVD 风险评分在 6 个月和 12 个月时的变化，次要结果包括收缩压；舒张压；总胆固醇；低密度脂蛋白；高密度脂蛋白；体重指数；以及对于患有糖尿病的患者，HbA1c。
在 428 名退伍军人中，50%为非裔美国人，85%为男性，33%有有限的健康素养。与教育对照组相比，临床药师专家提供的干预在 6 个月时并没有降低 CVD 风险评分（-1.8，95%CI-3.9 至 0.3；P=0.10）或 12 个月时（-0.3，95%CI-2.4 至 1.7；P=0.74）。在 6 个月或 12 个月时，收缩压、舒张压或低密度脂蛋白均未见差异。我们确实观察到干预组在 6 个月时总胆固醇显著下降（-7.0，95%CI-13.4 至-0.6；P=0.03）。在干预组中，34%的患者接受了至少 12 次计划干预电话中的 5 次，被认为是“依从者”。与对照组相比，干预的“依从者平均因果效应”的敏感性分析显示，6 个月时 CVD 风险评分降低的平均差异为 5.7（95%CI-12.0 至 0.7），12 个月时为-1.7（95%CI-7.6 至 4.8）。
尽管患者获得了更多的药剂师资源，但与教育对照组相比，在 12 个月的时间内，我们没有观察到随机分配到干预组的患者的 CVD 风险有显著改善。然而，该干预措施可能对积极参与的患者有积极影响，特别是在短期内。
