Development of the Patient-Focused Heart Failure Screening Questionnaire to Support a Predictive Heart Failure Algorithm in Patients Implanted With a Cardiac Electronic Device
Speaker(s)
Thompson Hilpert S1, Do HU1, Voskamp M1, Bonhomme CE2
1BIOTRONIK SE & Co KG, Berlin, BE, Germany, 2BIOTRONIK, Inc., Lake Oswego, OR, USA
OBJECTIVES: A predictive heart failure (HF) algorithm was developed to identify patients at higher risk of decompensation early through a multi-parametric automatically transmitted actionable alert1. A patient-focused Heart Failure Screening Questionnaire (HFSQ), which consists of eight closed-ended questions, was developed to support this predictive algorithm. The HFSQ is administered post-alert and collects patient-reported symptoms and behaviors that may indicate the onset of worsening HF. The HFSQ allows patients to be involved in their care and enables health care professionals (HCPs) to correlate remotely monitored CIED HF data with symptoms and behaviors reported by the patient into the HCPs' alert review workflow and clinical response.
METHODS: For the development of the HFSQ, an initial list of candidate questions was compiled based on existing HF self-management and symptom monitoring tools and a literature review of typical symptoms associated with worsening HF. Stylistic elements linked to patient engagement, such as layout, visualization, and question order, were also considered. The candidate questions were discussed and validated during interviews with ten HCPs, including cardiologist clinicians, HF nurse practitioners, and a cardiac physiologist. Feedback was implemented, enabling the development of a pilot version of the HFSQ.
RESULTS: The pilot HFSQ is currently undergoing validation through the two modes with which it can be administered, i.e. via an HCP interview or an integrated mobile application. Early feedback from a sample of HF patients (n=15) aged 50-79 monitored by a large university clinic in Australia suggests that the HFSQ is perceived as easily understandable and answerable. No patient thus far has indicated that being asked these questions might cause them additional anxiety. Two patients stated they would expect a personalized response from their HF care team after submitting the HFSQ.
CONCLUSIONS: Once pilot testing is complete, the HFSQ will be tested within a prospective clinical study.
1. D'Onofrio. Europace. 2022 Feb 2;24(2):234-244.Code
HSD40
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), STA: Medical Devices