Context People with chronic conditions may need tailored, practical help for managing their conditions. Contribution This 12-month trial of assistance with managing systolic- dysfunction heart failure randomly assigned 406 ethnically diverse adults from Harlem, New York, to usual care or nurse management. Nurses counseled nurse management patients about sodium intake, fluid buildup, medication adherence, and self-management of symptoms; served as a bridge between patients and physicians; and regularly called patients to discuss problems. Compared with usual care patients, nurse management patients had fewer hospitalizations and better functioning. Implications Nurse management can improve some outcomes in ethnically diverse patients with systolic-dysfunction heart failure in ambulatory practices. The Editors Heart failure disproportionately affects black and elderly people and is a leading cause of hospitalization among people 65 years of age or older (1, 2). Although effective therapies can improve functioning and survival in patients with systolic dysfunction, many patients may not be receiving the full benefit of existing knowledge (35). Patients play a critical role in managing a chronic condition, such as heart failure. Patients may not realize that specific symptoms are related to heart failure or that adhering to medications and diet can reduce symptoms and life-threatening episodes (6). Evidence-based guidelines for systolic dysfunction recommend that physicians not only offer patients effective therapies but also teach them the importance of adherence and self-monitoring (3, 4). Clinicians have fallen short in prescribing angiotensin-converting enzyme inhibitors and -blockers for patients with systolic dysfunction (5, 7, 8). When prescribed, the doses have often been lower than those proven to convey greater benefits (3, 9). Clinicians have also documented counseling only a fraction of patients with heart failure about self-management (10, 11). System-related factors may also influence patients' ability to obtain quality care (12, 13). Systematic reviews of clinical behavior change have suggested that interventions targeted to specific problems are more likely to be successful (14, 15). On the basis of shortfalls identified in patient self-management and clinical care in Harlem, New York, a predominately nonwhite area, we tailored a nurse management intervention to address documented problems and evaluated its effectiveness in a randomized, controlled trial. Our trial among primarily minority patients addresses important gaps in the literature. We targeted problems documented among patients with heart failure in Harlem, enrolled patients from ambulatory care practices, randomly assigned patients to either nurse management or usual care, and evaluated the patients' subsequent health-related outcomes. We hypothesized that patients in the focused nurse management program would have fewer hospitalizations and report better functioning than patients in usual care. Methods Development of the Intervention During interviews with patients with heart failure at Mount Sinai Hospital, New York, New York, patients reported inadequate understanding of heart failure and their role in managing it (6). Less than half of patients followed a very-low-salt diet, and only about one quarter weighed themselves daily. Regarding clinical management, medical records noted prescriptions for an angiotensin-converting enzyme inhibitor or hydralazinedinitrate combination in 82% of 322 consecutive black patients with documented systolic dysfunction who were scheduled for visits at the general medicine clinic at Harlem Hospital from February 1995 through February 1997. The prescribed doses, however, equaled or exceeded those found to be efficacious in clinical trials in only 26% of these patients (3). In designing a nurse management intervention to address these problems, we built on a Stanford University program that evaluated primarily privately insured patients at Kaiser Permanente in northern California (16, 17). We adapted their questionnaire on the frequency of foods eaten to incorporate those that are common among African-American and Hispanic people in Harlem. Settings and Recruitment All 4 hospitals in Harlem, the area's major providers, collaborated in the trial: 1 large private academic medical center (1171 beds), 2 medium-sized municipal hospitals (286 beds and 363 beds), and 1 smaller private community hospital (200 beds). In 2000, these hospitals had 521, 267, 218, and 168 discharges for the heart failure diagnosis-related group (code 127), respectively. All are not-for-profit institutions. The trial had the following inclusion criteria: adults 18 years of age or older; systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi or thallium stress testing, or left-heart catheterization); English-language or Spanish-language speakers; community-dwelling at enrollment; and current patient in a general medicine, geriatrics, or cardiology clinic or office at a participating site. Exclusion criteria were medical conditions that prevented interaction with the nurse, including blindness, deafness, or cognitive impairment; medical conditions requiring individualized management that might differ from standard protocol, namely pregnancy, renal dialysis, or terminal illness; or procedures that corrected systolic dysfunction, such as heart transplantation. Of the 216 clinicians (209 physicians and 7 physicians' assistants or nurse practitioners) in participating practices, 1 clinician declined permission to recruit his patients. The institutional review boards for each site approved the study. We identified patients with International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), and diagnosis-related group codes on outpatient or inpatient billings for heart failure, March 1999 through February 2001, who had at least 1 clinician visit to a participating practice and impaired systolic dysfunction. We defined impaired systolic dysfunction as a left ventricular ejection fraction less than 0.40 or moderately or severely reduced systolic dysfunction on echocardiography, radionuclide ventriculography, myocardial stress sestamibi or thallium stress testing, or left-heart catheterization. We obtained clinicians' permission to recruit specific patients and sent each approved patient a letter from the site's physician coordinator. Bilingual recruiters telephoned eligible patients or approached them at scheduled clinician appointments. The recruiter confirmed each patient's eligibility, obtained written informed consent to participate in the study, conducted the baseline survey, and telephoned the project manager for the treatment group assignment. The recruiter conveyed the assignment to the patient and, for each nurse management patient, scheduled the in-person appointment with a nurse. We provided telephone service for 3 patients who did not have it so we could telephone patients in both treatment groups every 3 months for data on end points and so nurse management patients could participate in the intervention. Randomization and Treatment Groups The project's statistician used a computer-generated, random-number sequence without blocking or stratification to centrally determine randomization assignments and concealed treatment group assignments in sealed, opaque envelopes. Usual care patients received federal consumer guidelines for managing systolic dysfunction but no other intervention (18). In the nurse management intervention, 1 of 3 trained registered nurses met once with each patient (Table 1). In counseling the patient, the nurse stressed the relationship among sodium intake; fluid buildup; and symptoms, such as shortness of breath. Nurses mailed patients the reports from the food-frequency questionnaire after each administration. The nurse also served as a bridge between the patient and the clinician (Table 1). A local clinical advisory committee implemented national evidence-based guidelines, and a committee of key clinicians from participating sites approved the protocol (3, 4). Nurses contacted patients' clinicians to discuss specific medications and arranged any prescription changes and examinations ordered (Table 1). An internist monitored the nurses' work, initially in weekly and then in biweekly meetings, and a cardiologist provided oversight and substituted for the internist at regular meetings, as necessary. Table 1. Components of Nurse Management* One nurse who was bilingual in English and Spanish delivered the intervention primarily at the 2 municipal hospitals, a second bilingual nurse delivered the intervention primarily at the small community hospital, and the second and a third English-languagespeaking nurse delivered the intervention primarily at the academic center. All 3 nurses covered each other, especially for the follow-up telephone calls. Outcomes and Measurement To measure hospitalizations, we used billing data from the 4 participating hospitals. At quarterly telephone surveys, interviewers who were blinded to treatment assignment asked patients about hospitalizations at nonparticipating hospitals; however, we present the analysis of billing data because they measure hospitalizations independent of possibly socially acceptable responses or survey nonresponse of the patients. For functional status, we used the generic Short Form-12 (SF-12) physical component score and the condition-specific Minnesota Living with Heart Failure (MLHF) Questionnaire, with both scales administered at the quarterly interviews. We measured deaths recorded in the National Death Index plus deaths reported by patients' families for patients with no subsequent billings. Since both nurse management and usual care involved only services delivered in routine practice, the study did not monitor adverse effects. As required by the academic
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