Telemedicine cardiovascular risk reduction in veterans: The CITIES trial

Abstract

Background: Comprehensive programs addressing tailored patient self-management and pharmacotherapy may reduce barriers to cardiovascular disease (CVD) risk reduction.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT01142908.