BACKGROUND: Despite therapies proven effective for heart failure with systolic dysfunction, the condition continues to cause substantial hospitalization, disability, and death, especially among African- American and other nonwhite populations. OBJECTIVE: To compare the effects of a nurse-led intervention focused on specific management problems versus usual care among ethnically diverse patients with systolic dysfunction in ambulatory care practices. DESIGN: Randomized effectiveness trial conducted from September 2000 to September 2002. SETTING: The 4 hospitals in Harlem, New York. PATIENTS: 406 adults (45.8% were non-Hispanic black adults, 32.5% were Hispanic adults, 46.3% were women, and 36.7% were > or =65 years of age) who met eligibility criteria: systolic dysfunction, English- or Spanish-language speakers, community-dwelling patients, and ambulatory care practice patients. INTERVENTION: During a 12-month intervention, bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians. MEASUREMENTS: Hospitalizations (in 406 of 406 patients during follow-up) and self-reported functioning (in 286 of 406 patients during follow-up) at 12 months. RESULTS: At 12 months, nurse management patients had had fewer hospitalizations (143 hospitalizations vs. 180 hospitalizations; adjusted difference, -0.13 hospitalization/person-year [95% CI, -0.25 to -0.001 hospitalization/person-year]) than usual care patients. They also had better functioning: The Short Form-12 physical component score was 39.9 versus 36.3, respectively (difference, 3.6 [CI, 1.2 to 6.1]), and the Minnesota Living with Heart FailureQuestionnaire score was 38.6 versus 47.3, respectively (difference, -8.8 [CI, -15.3 to -2.2]). Through 12 months, 22 deaths occurred in each group and percentages of patients who were hospitalized at least once were similar in each group (30.5% of nurse management patients vs. 36.5% of control patients; adjusted difference, -7.1 percentage points [CI, -16.9 to 2.6 percentage points]). LIMITATIONS: Three nurses at 4 hospitals delivered interventions in this modest-sized trial, and 75% of the participants were from 1 site. It is not clear which aspects of the complex intervention accounted for the results. CONCLUSIONS:Nurse management can improve functioning and modestly lower hospitalizations in ethnically diverse ambulatory care patients who have heart failure with systolic dysfunction. Sustaining improved functioning may require continuing nurse contact.
RCT Entities:
BACKGROUND: Despite therapies proven effective for heart failure with systolic dysfunction, the condition continues to cause substantial hospitalization, disability, and death, especially among African- American and other nonwhite populations. OBJECTIVE: To compare the effects of a nurse-led intervention focused on specific management problems versus usual care among ethnically diverse patients with systolic dysfunction in ambulatory care practices. DESIGN: Randomized effectiveness trial conducted from September 2000 to September 2002. SETTING: The 4 hospitals in Harlem, New York. PATIENTS: 406 adults (45.8% were non-Hispanic black adults, 32.5% were Hispanic adults, 46.3% were women, and 36.7% were > or =65 years of age) who met eligibility criteria: systolic dysfunction, English- or Spanish-language speakers, community-dwelling patients, and ambulatory care practice patients. INTERVENTION: During a 12-month intervention, bilingual nurses counseled patients on diet, medication adherence, and self-management of symptoms through an initial visit and regularly scheduled follow-up telephone calls and facilitated evidence-based changes to medications in discussions with patients' clinicians. MEASUREMENTS: Hospitalizations (in 406 of 406 patients during follow-up) and self-reported functioning (in 286 of 406 patients during follow-up) at 12 months. RESULTS: At 12 months, nurse management patients had had fewer hospitalizations (143 hospitalizations vs. 180 hospitalizations; adjusted difference, -0.13 hospitalization/person-year [95% CI, -0.25 to -0.001 hospitalization/person-year]) than usual care patients. They also had better functioning: The Short Form-12 physical component score was 39.9 versus 36.3, respectively (difference, 3.6 [CI, 1.2 to 6.1]), and the Minnesota Living with Heart Failure Questionnaire score was 38.6 versus 47.3, respectively (difference, -8.8 [CI, -15.3 to -2.2]). Through 12 months, 22 deaths occurred in each group and percentages of patients who were hospitalized at least once were similar in each group (30.5% of nurse management patients vs. 36.5% of control patients; adjusted difference, -7.1 percentage points [CI, -16.9 to 2.6 percentage points]). LIMITATIONS: Three nurses at 4 hospitals delivered interventions in this modest-sized trial, and 75% of the participants were from 1 site. It is not clear which aspects of the complex intervention accounted for the results. CONCLUSIONS: Nurse management can improve functioning and modestly lower hospitalizations in ethnically diverse ambulatory care patients who have heart failure with systolic dysfunction. Sustaining improved functioning may require continuing nurse contact.
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