A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV

Abstract

Background: Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. Positive effects of disease management programs have been shown for patients with heart failure (HF). Remote monitoring and telemonitoring with active intervention are beneficial in atrial fibrillation (AF) and therapy-resistant hypertension (TRH), respectively. For these patients, we have developed a novel integrated care concept (NICC) which combines telemedicine with intensive support by a care center, including a call center, an integrated care network including inpatient and outpatient care providers and guideline therapy for patients.

Methods: The aim of the study is to demonstrate the superiority of NICC over guideline therapy alone. The trial is designed as open-label, bi-center, parallel-group design with two groups and a blinded observer. Patients will be included if they are either inpatients or if they are referred to the outpatient clinic of the hospitals by their treating physician. Randomization will be done individually with stratification by cardiovascular disease (AF, HF, TRH), center and admission type. Primary endpoints are based on the 1-year observation period after randomization. The first primary endpoint is the composite endpoint consisting of mortality, stroke and myocardial infarction. The number of hospitalizations form the second primary endpoint. The third primary endpoint is identical to the first primary endpoint plus cardiac decompensation. Adjustments for multiple testing are done using a fall-back strategy. Secondary endpoints include patient adherence, health care costs, quality of life, and safety. A sample size of 2930 gives 80% power at the two-sided 2.5% test level for the first primary endpoint. The power for the second primary endpoint is 99.8% at this sample size, and it is 80% with 1086 patients.

Discussion: This study will inform care providers whether quality of care can be improved by an integrated care concept providing telemedicine through a round-the-clock call center approach. We expect that cost of the NICC will be lower than standard care because of reduced hospitalizations. If the study has a positive result, NICC is planned to be immediately rolled out in the federal state of Mecklenburg-West Pomerania and other federal states in Germany. The trial will also guide additional research to disentangle the effects of this complex intervention.

Trial registration: DRKS, ID: DRKS00013124 . Registered on 5 October 2017; ClinicalTrials.gov , ID: NCT03317951. Registered on 17 October 2017.

Keywords: Atrial fibrillation; Care center; Disease management program; Evidence-based care; Heart failure; Hospitalization; Integrated care; Randomized controlled trial; Telemedicine; Treatment-resistant hypertension.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was obtained from the Ethics Committee of the Medical Faculty of the University of Rostock on 18 July 2017, and its registration number is A 2017–0117.

Written informed consent for trial participation will be obtained from all patients prior to randomization.

Consent for publication

Not applicable

Competing interests

Armin Brüge is an employee of Philips Medizin Systeme Böblingen GmbH. Drs. Henriette Neumeyer and Gisela Hostenkamp are employees of Philips GmbH Market DACH. Dr. Katja Krockenberger is an employee of AMEDON GmbH, and Bernard Brandewiede is CEO of AMEDON GmbH. All other authors declare no conflict of interest.

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Figures

Fig. 1

Study flow

Fig. 2

Integration of patients into the novel integrated care concept (NICC) platform

Fig. 3

Patient management process