Current KORA Studies
KORINNA - "Koronarinfarkt-Nachbehandlung im Alter"
A Case Management Intervention for Aged Patients with Myocardial Infarction
The study aims at assessing whether a case management intervention by trained nurses can reduce readmission in aged patients with myocardial infarction. Furthermore we estimate the cost-utility of this case management intervention.
Institute of Health Economics and Health Care Management
Project KORINNA: "A Case Management Intervention for Aged Patients with Myocardial Infarction" (2008-2011)
PRINCIPAL INVESTIGATORS:
Christa Meisinger, MD, MPH
Augsburg Hospital, MONICA/KORA Myocardial Infarction Registry
Stenglinstr. 2, 86156 Augsburg, Germany
Tel: ++49/821/400-4373
Fax: ++49/821/400-2838
christa.meisinger/at/helmholtz-muenchen.de
Bernhard Kuch, MD
Augsburg Hospital, Department of Internal Medicine I – Cardiology
Stenglinstr. 2, 86156 Augsburg, Germany
Tel: ++49/821/400-2956
Fax: ++49/821/400-3739
kuchb/at/aol.com
Rolf Holle, Prof. Dr.
Helmholtz Zentrum München – German Research Center for Environmental Health
Ingolstädter Landstr. 1, 85758 Neuherberg
Tel: ++49/89/3187-4192
Fax: ++49/89/3187-3375
holle/at/helmholtz-muenchen.de
TITLE OF STUDY:
A case management intervention for aged patients with myocardial infarction
CONDITION/TOPIC:
Myocardial infarction
OBJECTIVE(S):
- To assess whether a case management intervention by trained nurses can reduce readmission in aged patients with myocardial infarction
- To estimate the cost-utility of this case management intervention
INTERVENTION (S):
Experimental intervention: Case management by trained nurse on the basis of telephone contacts and home visits
Control intervention: Usual care
Duration of intervention per patient: One year
KEY INCLUSION AND EXCLUSION CRITERIA:
Key inclusion criteria: Patients with acute myocardial infarction, aged 70 years and older, living at home
Key exclusion criteria: insufficient command of German language, patients already receiving regular ambulatory home care
OUTCOME(S):
Primary efficacy endpoint: Unplanned rehospitalisation (or out of hospital death)
Primary economic endpoint: Incremental costs per quality adjusted life year (QALY) gained
Key secondary endpoints: Functional status, quality of life, costs, adherence to medication
STUDY TYPE:
Randomized, observer blind parallel group study
STATISTICAL ANALYSIS:
Efficacy: time-to-first unplanned readmission (or death) analysed by survival analysis methods (log rank test and/or Cox model)
Description of the primary analysis and population: Time to combined endpoint (rehospitalisation or death) will be compared between treatment groups in the intention-to-treat population
Economic analysis: estimation of incremental cost-utility ratio with confidence interval based on bootstrap estimation
Safety: all occurrences of readmission or death will be monitored regularly
Secondary endpoints: analysis by linear and generalized linear models
SAMPLE SIZE:
To be assessed for eligibility n = 400
To be allocated to trial: n = 338
To be analysed: n = 302
TRIAL DURATION:
First patient in to last patient out: 27 months
Duration of the entire trial: 36 months (including data cleaning and analysis)
SUMMARY
Background: Patients with coronary heart disease (CHD), in particular aged patients, have a high prevalence of co-morbidity associated with poor quality of life, physical disability, high health care costs, multiple medications, and increased risk for adverse outcomes.
Objective: In a randomized clinical trial in aged patients (70+ years) with myocardial infarction (MI) it will be evaluated whether a case management intervention by trained nurses will reduce readmission or death, and improve health-related outcomes like functional status, quality of life, and others. To evaluate cost-utility, the additional costs per quality-adjusted life year (QALY) gained will be calculated.
Design: Patients will be randomized to either case management intervention or usual care. After discharge from the index hospitalization, standardized telephone interviews as well as home visits will take place as part of the intervention. Twelve months after the index hospitalization patients in both groups will be re-assessed by the study physician. The assessment will be observer-blind and blood samples will be collected.
Analysis: Time to first readmission (or out-of-hospital death) will be analyzed by Cox model. The economic analysis will be based on the incremental cost-utility ratio and its confidence interval estimated by bootstrap methods.
Consequences: The findings should be used to guide clinicians, administrators and policy makers in the provision of high-quality care to older patients with CHD and comorbidities.
PARTICIPATING CENTERS:
This is a monocenter study with Klinikum Augsburg as the only recruiting study site. During follow-up, participation of the treating GPs in the region of Augsburg is sought for validation of patient information about events.