Case management by a specially trained nurse-led team, including CHWs, has been shown to be among the most efficacious strategies to improve management of CVD risk factors in many studies [31
]. Several studies have shown that nurse management clinics are at least as beneficial in achieving goals as are other clinics managed by physicians, and in many cases actually result in marked improvement in the outcomes including patient satisfaction and utilization of healthcare services, compared with usual care. For example, trained nurses providing care have demonstrated the most successful of strategies for improving lipid levels in patients with elevated LDL-C and BP [32
]. In the nurse management models, factors such as patient education and counseling and regular telephone follow-up by a nurse showed marked sustained improvement in medication adherence and goal achievement. Nurse case managers have been shown to improve adherence to guidelines in part by serving as a bridge to physician care and by adhering more strictly to management algorithms, including many counseling features that are not within the time frame of a busy physician in practice [52
]. Several studies suggest that a nurse-led team management program is the most effective strategy to date for reducing LDL-C [54
Nurses managing patients with diabetes also have a more favorable impact on chronic disease parameters, including adherence to recommendations for diet and for renal testing [55
]. Nurse case management improves control of diabetes in clinical settings, with significant reductions in fasting blood glucose, body weight, glycosylated hemoglobin, and LDL-C [56
]. Telephone management of diabetic patients by a nurse has been shown to markedly improve CHD risk factors, including lipids. Diabetic patients were more likely to be appropriately treated with a lipid lowering therapy when managed by the nurse over the phone than patients managed solely with usual care [57
In low income and minority populations, CHWs or lay health advisors have participated in team-based care for the management of CVD risk factors, particularly hypertension and diabetes [58
]. While there are too few randomized clinical trials of the role of these individuals, there is sufficient collective experience to suggest that this role can be an important one in improving adherence in high risk subsets of the population [46
]. Trained CHWs, front line health and human service care providers, are most often indigenous workers who share the same ethnicity, geographic community, and socioeconomic background of the patients they serve. The theoretical rationale for using CHWs is a shared perspective and experience. This unique connection not only enhances trust between CHW and the patient, but enables the CHW to effectively link underserved populations to healthcare resources where traditional health education and outreach efforts have failed [64
]. CHWs also serve as a bridge between the patient population and health care providers with communication of barriers to care and treatment which catalyze provider and health system changes [66
]. CHWs have been shown to improve quality of care, satisfaction with care, increase access to care, reduce healthcare costs, strengthen local economies and families, and foster community capacity building [58
]. CHWs also have been shown to be effective in research as interviewers and interventionists [46
This clinical trial addresses some limitations of previous studies by the incorporation of a rigorous cost-effectiveness evaluation, integration of the care model into federally-qualified community health centers, and adoption of a translational approach by not providing free clinical care or free medications. There are limitations of the COACH Trial. First, the recruitment and screening process resulted in the inclusion of a sample of predominately Black women. However this represents the majority of patients seen in these community health clinics which increases confidence in the generalizability of findings to similar settings and populations. Second, physicians had patients in both the CI and UC groups. This may have resulted in a change in the level of care provided to their patients in the UC group as they tended to become more vigilant with the assessment, treatment and follow-up for cardiovascular risk factor management. This may result in a type-2 error if no differences are found in the final analysis.
This effectiveness study will provide critical, real-world data regarding the implementation and testing of a NP/CHW case management intervention for the reduction of total cardiovascular risk in a high-risk vulnerable population. The community-based participatory research partnership has provided the opportunity to address a serious problem with the capacity to study it well, and intervene using the best practices incorporated into settings where the need is greatest with the potential to demonstrate an impact on health disparities. The proposed increase in the percentage of high-risk women and men who receive recommended therapies and achieve goal levels could potentially result in a marked decrement in the annual CVD-related mortality and costs if applied within primary care settings to populations with the characteristics of the target groups in this study.