BACKGROUND:Case management (CM) is a systematic approach to supplement physician-centered efforts to prevent cardiovascular disease (CVD). Research is limited on its implementation and efficacy in low-income, ethnic minority populations. METHODS: We conducted a randomized clinical trial to evaluate a nurse- and dietitian-led CM program for reducing major CVD risk factors in low-income, primarily ethnic minority patients in a county health care system, 63.0% of whom had type 2 diabetes mellitus. The primary outcome was the Framingham risk score (FRS). RESULTS: A total of 419 patients at elevated risk of CVD events were randomized and followed up for a mean of 16 months (81.4% retention). The mean FRS was significantly lower for the CM vs usual care group at follow-up (7.80 [95% confidence interval, 7.21-8.38] vs 8.93 [8.36-9.49]; P = .001) after adjusting for baseline FRS. This is equivalent to 5 fewer heart disease events per 1000 individuals per year attributable to the intervention or to 200 individuals receiving the intervention to prevent 1 event per year. The pattern of group differences in the FRS was similar in subgroups defined a priori by sex and ethnicity. The main driver of these differences was lowering the mean (SD) systolic (-4.2 [18.5] vs 2.6 [22.7] mm Hg; P = .003) and diastolic (-6.0 [11.6] vs -3.0 [11.7] mm Hg; P = .02) blood pressures for the CM vs usual care group. CONCLUSION: Nurse and dietitian CM targeting multifactor risk reduction can lead to modest improvements in CVD risk factors among high-risk patients in low-income, ethnic minority populations receiving care in county health clinics. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00128687.
RCT Entities:
BACKGROUND: Case management (CM) is a systematic approach to supplement physician-centered efforts to prevent cardiovascular disease (CVD). Research is limited on its implementation and efficacy in low-income, ethnic minority populations. METHODS: We conducted a randomized clinical trial to evaluate a nurse- and dietitian-led CM program for reducing major CVD risk factors in low-income, primarily ethnic minority patients in a county health care system, 63.0% of whom had type 2 diabetes mellitus. The primary outcome was the Framingham risk score (FRS). RESULTS: A total of 419 patients at elevated risk of CVD events were randomized and followed up for a mean of 16 months (81.4% retention). The mean FRS was significantly lower for the CM vs usual care group at follow-up (7.80 [95% confidence interval, 7.21-8.38] vs 8.93 [8.36-9.49]; P = .001) after adjusting for baseline FRS. This is equivalent to 5 fewer heart disease events per 1000 individuals per year attributable to the intervention or to 200 individuals receiving the intervention to prevent 1 event per year. The pattern of group differences in the FRS was similar in subgroups defined a priori by sex and ethnicity. The main driver of these differences was lowering the mean (SD) systolic (-4.2 [18.5] vs 2.6 [22.7] mm Hg; P = .003) and diastolic (-6.0 [11.6] vs -3.0 [11.7] mm Hg; P = .02) blood pressures for the CM vs usual care group. CONCLUSION: Nurse and dietitian CM targeting multifactor risk reduction can lead to modest improvements in CVD risk factors among high-risk patients in low-income, ethnic minority populations receiving care in county health clinics. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00128687.
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