Hayden B Bosworth1, Maren K Olsen2, Felicia McCant3, Karen M Stechuchak3, Susanne Danus3, Matthew J Crowley3, Karen M Goldstein4, Leah L Zullig5, Eugene Z Oddone6. 1. 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. Electronic address: hayden.bosworth@duke.edu. 2. 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. 3. Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC. 4. Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Ambulatory Care Services, Durham Veterans Affairs Medical Center, Durham, NC. 5. 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. 6. Health Services Research in Primary Care, Center of Innovation, Durham Veterans Affairs Medical Center, Durham, NC; Division of General Internal Medicine, Duke University, Durham, NC.
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.
RCT Entities:
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.
Authors: Allison A Lewinski; Hayden B Bosworth; Karen M Goldstein; Jennifer M Gierisch; Shelley Jazowski; Felicia McCant; Courtney White-Clark; Valerie A Smith; Leah L Zullig Journal: Contemp Clin Trials Commun Date: 2021-02-06
Authors: Christi S Ulmer; Felicia McCant; Karen M Stechuchak; Maren Olsen; Hayden B Bosworth Journal: J Clin Sleep Med Date: 2021-07-01 Impact factor: 4.324