The proposed study could significantly improve Cardiovascular Disease (CVD) risk management among veterans for several reasons: 1) This intervention was a novel extension of our previous efficacious interventions that addressed multiple chronic conditions contributing to CVD risk. 2) The intervention focused on both multiple CVD-related behaviors and medication management. 3) The intervention was developed to ensure implementation across a large and representative sample of veterans; and, 4) The intervention, once found efficacious and financially self-sustaining, could be widely implemented within the VA healthcare system.
The study took place in two VA primary care clinics (Community Based Outpatient Clinic (CBOC) and primary care clinic affiliated with a hospital). We attempted to reduce CVD risk among vulnerable, high risk veterans (e.g., African Americans, low literate) by addressing the modifiable risk factors of systolic blood pressure (SBP), smoking, and low-density lipoprotein cholesterol (LDL-C). The intervention was tailored to the needs of patients and delivered by a pharmacist familiar with the clinics, thereby enhancing the potential for benefit and generalizability to other settings.
The study is one of the first to compare whether patients randomized to a clinical pharmacist-administered telephone behavioral/medication management intervention tailored to their needs improve CVD outcomes relative to a control group over 12 months. We received a 9 month extension to examine the impact of the intervention among women veterans as well as across gender groups.
The proposed study will examine two research questions:
1. Can patients randomized to a clinical pharmacist-administered telephone behavioral/medication management intervention tailored to their needs improve CVD outcomes relative to a control group over 12 months?
Primary Hypothesis: (H1) Veterans who receive the behavioral/medication intervention will have greater improvement of their CVD Risk Profile over the 12 months of follow-up as compared to the control group.
Secondary Hypotheses: (H2) Veterans who receive the intervention will have improved medication adherence, physical activity, improved diet, lower body mass index as compared to the control group over 12 months of follow-up. (H3) Veterans who receive the intervention will have greater improvements in LDL over the 12 months of follow-up as compared to the control group. (H4) Veterans
with diabetes who receive the intervention will have greater improved HbA1c as compared to the control group over 12 months of follow-up.
2. If the intervention is found to be effective, is it cost effective?
A two-arm randomized with 12 month follow-up. Patients were selected from primary care clinics at the Raleigh CBOC and Durham VAMC hospital based primary care clinic. Of the 2153 contacted patients, 428 were randomized to either intervention or usual care. The pharmacist intervention calls were attempted to be delivered to all intervention patients on a monthly basis. Patients randomized to the control group received educational material about CVD reduction at baseline & 6month follow-up.
We enrolled 428 participants and randomized 213 to usual care and 215 to pharmacist intervention. The mean age was 61.2 years; 51% were minority; 15% women were enrolled; 33.4%% had limited health literacy. Baseline CVD risk was 32%. Baseline systolic and diastolic BP was 130.0/75.8 mmHg, while LDL was 124.7 and among the n=171 patients with diabetes, mean Glycated hemoglobin (Hba1C) was 7.8.
352 (82%) completed the 12 month follow-up. Relative to usual care, pharmacist intervention showed marginal, but not statistically significant, improvement in CVD risk at 6 (-1.78, 95% CI: -3.9, 0.3; p=0.10) and 12 months (-0.34, 95% CI: -2.4,1.7; p=0.75). Patients in the pharmacist intervention did not show improvement in SBP at 12 month relative to usual care (1.4, 95% CI: -1.5,4.3; p=0.34).
While the pharmacist intervention did not show statistically significant improvement overall, we have yet to conduct within group comparison on race, gender and intervention dose. Our expectation is that similar to other studies there will be group differences.
Cardiovascular disease (CVD) is the leading cause of death in the U.S.; more than 80% of veterans have > 2 risk factors for CVD. Additionally, certain groups including women veterans and racial minorities are at greatest risk for poor CVD control. An intervention that addresses multiple CVD risk factors among high-risk veterans may have potential to improve morbidity and mortality. However, matching the intervention to individuals with particular CVD risks are essential to ensure adequate use of limited resources and improve outcomes. Given the national prevalence of CVD and the dismal rates of risk factor control, intensive, but easily disseminated interventions are needed to improve treatment of this epidemic in the VA and identify how best to serve all veterans.
- Bosworth HB, Olsen MK, McCant F, Stechuchak KM, Danus S, Crowley MJ, Goldstein KM, Zullig LL, Oddone EZ. Telemedicine cardiovascular risk reduction in veterans: The CITIES trial. American heart journal. 2018 May 1; 199:122-129.
- Goldstein KM, Oddone EZ, Bastian LA, Olsen MK, Batch BC, Washington DL. Characteristics and Health Care Preferences Associated with Cardiovascular Disease Risk among Women Veterans. Women's health issues : official publication of the Jacobs Institute of Women's Health. 2017 Nov 1; 27(6):700-706.
- Goldstein KM, Stechuchak KM, Zullig LL, Oddone EZ, Olsen MK, McCant FA, Bastian LA, Batch BC, Bosworth HB. Impact of Gender on Satisfaction and Confidence in Cholesterol Control Among Veterans at Risk for Cardiovascular Disease. Journal of women's health (2002). 2017 Jul 1; 26(7):806-814.
- Zullig LL, Stechuchak KM, Goldstein KM, Olsen MK, McCant FM, Danus S, Crowley MJ, Oddone EZ, Bosworth HB. Patient-reported medication adherence barriers among patients with cardiovascular risk factors. Journal of managed care & specialty pharmacy. 2015 Jun 1; 21(6):479-85.
- Zullig LL, Melnyk SD, Stechuchak KM, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Edelman D, Rakley S, Morey M, Bosworth HB. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES): rationale for a tailored behavioral and educational pharmacist-administered intervention for achieving cardiovascular disease risk reduction. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2014 Feb 1; 20(2):135-43.
- Melnyk SD, Zullig LL, McCant F, Danus S, Oddone E, Bastian L, Olsen M, Stechuchak KM, Edelman D, Rakley S, Morey M, Bosworth HB. Telemedicine cardiovascular risk reduction in veterans. American heart journal. 2013 Apr 1; 165(4):501-8.
- Goldstein K, Melnyk SD, Zullig LL, Stechuchak KM, Oddone EZ, Bastian L, Rakley S, Olsen MK, Bosworth HB. Gender and Racial Differences in Control of Cardiovascular Disease Risk Factors among Veterans. Poster session presented at: VA Durham VAMC Annual Research Week; 2014 May 13; Durham, NC.
- Goldstein K, Melnyk SD, Zullig LL, Stechuchak KM, Oddone EZ, Bastian L, Rakley S, Olsen MK, Bosworth HB. Gender and Racial Differences in Control of Cardiovascular Disease Risk Factors Among Veterans. Poster session presented at: Society of General Internal Medicine Midwest Regional Annual Meeting; 2014 Apr 23; San Diego, CA.
Treatment - Comparative Effectiveness
Behavior (patient), Cardiovasc’r disease, Diabetes