Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial

BACKGROUND: Aged patients with coronary heart disease (CHD) have a high prevalence of co-morbidity associated with poor quality of life, high health care costs, and increased risk for adverse outcomes. These patients are often lacking an optimal home care which may result in subsequent readmissions. However, a specific case management programme for elderly patients with myocardial infarction (MI) is not yet available. The objective of this trial is to examine the effectiveness of a nurse-based case management in patients aged 65 years and older discharged after treatment of an acute MI in hospital. The programme is expected to influence patient readmission, mortality and quality of life, and thus to reduce health care costs compared with usual care. In this paper the study protocol is described. METHODS/DESIGN: The KORINNA (Koronarinfarkt Nachbehandlung im Alter) study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg). Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost-effectiveness ratio (ICER) will be calculated. DISCUSSION: The KORINNA study will contribute to the evidence regarding the effectiveness of case management programmes in aged people with MI. The results can be an important basis for clinicians, administrators and health policy makers to decide on the provision of high-quality care to older patients with CHD. TRIAL REGISTRATION: ISRCTN02893746