Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 22, 2020
Date Accepted: Jul 28, 2020
Quality assessment of an integrated care pathway using telemonitoring in patients with chronic heart failure and COPD (RPM-CHF/COPD trial): a study protocol
ABSTRACT
Background:
Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often co-exist and are associated with a high morbidity and reduced health-related quality of life (HRQoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring (TM) to detect deterioration at an early stage, and a single case manager for both diseases.
Objective:
This study aims to investigate whether an integrated care pathway using TM in patients with combined CHF and COPD, results in a higher general HRQoL, as compared to the traditional care pathways. Secondary endpoints include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program and cost-effectiveness.
Methods:
This is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided in a pre-intervention phase (6 months) and a post-intervention phase (2 years) in which endpoints are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by TM-guided treatment.
Results:
Following ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021
Conclusions:
This study is the first to evaluate the effects of a novel integrated care pathway using TM for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern TM technology is used instead of regular care and not as an addition to regular care. Clinical Trial: Netherlands Trial Register. NL6741 Registered: 11 December 2017, https://www.trialregister.nl/trial/6741
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