Cost-effectiveness of a telemonitoring programme in patients with cardiovascular diseases compared with standard of care.

OBJECTIVES: The main aim of this work was to analyse the cost-effectiveness of an integrated care concept (NICC) that combines telemonitoring with the support of a care centre in addition to guideline therapy for patients. Secondary aims were to compare health utility and health-related quality of life (QoL) between NICC and standard of care (SoC). METHODS: The randomised controlled CardioCare MV Trial compared NICC and SoC in patients from Mecklenburg-West Pomerania (Germany) with atrial fibrillation, heart failure or treatment-resistant hypertension. QoL was measured using the EQ-5D-5L at baseline, 6 months and 1 year follow-up. Quality-adjusted life years (QALYs), EQ5D utility scores, Visual Analogue Scale (VAS) Scores and VAS adjusted life years (VAS-AL) were calculated. Cost data were obtained from health insurance companies, and the payer perspective was taken in health economic analyses. Quantile regression was used with adjustments for stratification variables. RESULTS: The net benefit of NICC (QALY) was 0.031 (95% CI 0.012 to 0.050; p=0.001) in this trial involving 957 patients. EQ5D Index values, VAS-ALs and VAS were larger for NICC compared with SoC at 1 year follow-up (all p≤0.004). Direct cost per patient and year were €323 (CI €157 to €489) lower in the NICC group. When 2000 patients are served by the care centre, NICC is cost-effective if one is willing to pay €10 652 per QALY per year. CONCLUSION: NICC was associated with higher QoL and health utility. The programme is cost-effective if one is willing to pay approximately €11 000 per QALY per year.

Comparison of telemonitoring combined with intensive patient support with standard care in patients with chronic cardiovascular disease - a randomized clinical trial.

IMPORTANCE: Healthcare concepts for chronic diseases based on tele-monitoring have become increasingly important during COVID-19 pandemic. OBJECTIVE: To study the effectiveness of a novel integrated care concept (NICC) that combines tele-monitoring with the support of a call centre in addition to guideline therapy for patients with atrial fibrillation, heart failure, or treatment-resistant hypertension. DESIGN: A prospective, parallel-group, open-label, randomized, controlled trial. SETTING: Between December 2017 and August 2019 at the Rostock University Medical Center (Germany). PARTICIPANTS: Including 960 patients with either atrial fibrillation, heart failure, or treatment-resistant hypertension. INTERVENTIONS: Patients were randomized to either NICC (n = 478) or standard-of-care (SoC) (n = 482) in a 1:1 ratio. Patients in the NICC group received a combination of tele-monitoring and intensive follow-up and care through a call centre. MAIN OUTCOMES AND MEASURES: Three primary endpoints were formulated: (1) composite of all-cause mortality, stroke, and myocardial infarction; (2) number of inpatient days; (3) the first plus cardiac decompensation, all measured at 12-months follow-up. Superiority was evaluated using a hierarchical multiple testing strategy for the 3 primary endpoints, where the first step is to test the second primary endpoint (hospitalization) at two-sided 5%-significance level. In case of a non-significant difference between the groups for the rate of hospitalization, the superiority of NICC over SoC is not shown. RESULTS: The first primary endpoint occurred in 1.5% of NICC and 5.2% of SoC patients (OR: 3.3 [95%CI 1.4-8.3], p = 0.009). The number of inpatient treatment days did not differ significantly between both groups (p = 0.122). The third primary endpoint occurred in 3.6% of NICC and 8.1% of SoC patients (OR: 2.2 [95%CI 1.2-4.2], p = 0.016). Four patients died of all-cause death in the NICC and 23 in the SoC groups (OR: 4.4 [95%CI 1.6-12.6], p = 0.006). Based on the prespecified hierarchical statistical analysis protocol for multiple testing, the trial did not meet its primary outcome measure. CONCLUSIONS AND RELEVANCE: Among patients with atrial fibrillation, heart failure, or treatment-resistant hypertension, the NICC approach was not superior over SoC, despite a significant reduction in all-cause mortality, stroke, myocardial infarction and cardiac decompensation. Trial registration ClinicalTrials.gov Identifier: NCT03317951.

Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease.

BACKGROUND: Cardiovascular diseases are the major cause of death globally and represent a major economic burden on health care systems. For patients with heart failure, atrial fibrillation or therapy-resistant hypertension, 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 (Schmidt et al. 2018 Trials 19:120). Here, we describe challenges and solutions in patient recruitment and provide the statistical analysis plan. METHODS: The study CardioCare MV is a prospective, randomized, controlled, parallel-group, open-label, bi-center trial with two groups for comparing NICC with standard of care (SoC). Because of issues with patient enrollment we adapted the study plan after consultation with the Ethics Committee and the funding agency. We altered the analysis strategy for the primary endpoints, which led to a change in the required sample size. We also changed the access points to patients from inpatient hospitals specialized in the treatment of patients with cardiovascular disease to specialized practices. RESULTS: Recruitment of patients started on 1 December 2017, and first patient in was on 4 December 2017. Recruitment was completed on 15 August 2019 as planned according to the amended study plan. The follow-up period will end in August 2020. A total of 964 patients was enrolled into the trial. The statistical analysis plan was finalized prior to last patient in. Results will be available by the end of 2020. DISCUSSION: The trial 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. The trial will 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.