gms | German Medical Science

Introduction: Despite advances in the treatment of heart failure (HF), many patients remain at a high residual risk. HF is the most common cause of hospitalization in Germany and is associated with a markedly reduced quality of life (QoL). In 2018, the Federal Joint Committee (GBA) published a proposal for a Disease Management Program (DMP) for HF patients (DMP-HI) [1]. In 2021, the Institute for Quality and Efficiency in Health Care (IQWiG) published a report on the DMP-HI, which concluded that it required revision [2]. Structured multidisciplinary care programmes may have beneficial long-term effects [3]. The HI-PLUS trial is investigating, whether implementation of an evidence-based structured care program improves QoL among HF patients compared to usual care. Piloting the study conduct in such trials is crucial to improve trial performance and increase likelihood of successful completion. The here presented pilot phase of the HI-PLUS trial was designed to assess the feasibility, acceptability, and procedures of the main trial.

Methods: HI-PLUS is a cluster-randomized parallel-arm controlled trial funded within the German Innovation Fund (Grant #01NVF19029; registered as DRKS00031997). In the control group, HF patients are treated according to usual care. In the intervention group, 5 elements are added: a) care program derived from a positively evaluated trial; b) eHealth telemonitoring and documentation platform; c) portable telemedical devices (scales, BP monitor, ECG) as needed; d) care implementation supported through a specifically trained non-medical assistant qualified in HF (HI-MFA); e) enhanced communication between cardiologist and general practitioner via HI-MFA and eHealth platform. The primary endpoint is an improvement in disease-specific QoL (Kansas City Cardiomyopathy Questionnaire) after 12 months. The HI-PLUS trial aims to recruit 56 clusters and 1350 patients. During the pilot phase, the baseline assessment was tested. It consisted of a physical examination, a consultation with the cardiologist and a telephone survey administered by trained staff using standardised questionnaires. The study database and the eHealth platform were also piloted. Both the participating cardiological practices (CP) and the study participants completed a feedback questionnaire at the end of the pilot phase.

Results: Two CP participated in the pilot phase between May and July 2023. Four patients with heart failure were recruited (each CP recruited 2 patients). The average age was 68 ± 10 years, 3 were male and 2 were in NYHA class II. All screened patients participated. The duration of the processes (patient information, baseline assessment, data entry) in the CP took approximately 60 minutes per patient. Based on CP feedback, the research team critically reviewed and revised SOPs for recruitment, patient inclusion and informed consent. Additionally, a patient recruitment checklist was developed. Patient feedback on the duration, satisfaction, and comprehensibility of telephone surveys was positive. The average duration of the telephone survey was 40 ± 8 minutes.

Conclusion: The pilot phase successfully evaluated study documents, SOPs, questionnaires, organizational feasibility, data collection methods, study acceptance, participant and CP satisfaction, and usability of the eHealth platform. The findings of the pilot phase were integrated into the main trial.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.