Protocol for the enhanced management of multimorbid patients with COPD and severe asthma: role of indoor air quality

Abstract

Introduction: Reducing unplanned hospital admissions in chronic patients at risk is a key area for action due to the high healthcare and societal burden of the phenomenon. The inconclusive results of preventive strategies in patients with chronic obstructive respiratory disorders and comorbidities are explainable by multifactorial but actionable factors.The current protocol (January 2024-December 2025) relies on the hypothesis that intertwined actions in four dimensions: (1) management change, (2) personalisation of the interventions based on early detection/treatment of acute episodes and enhanced management of comorbidities, (3) mature digital support and (4) comprehensive assessment, can effectively overcome most of the limitations shown by previous preventive strategies. Accordingly, the main objective is to implement a novel integrated care preventive service for enhanced management of these patients, as well as to evaluate its potential for value generation.

Methods and analysis: At the end of 2024, the specifics of the novel service will be defined through the articulation of its four main components: (1) enhanced lung function testing through oscillometry, (2) continuous monitoring of indoor air quality as a potential triggering factor, (3) digital support with an adaptive case management (ACM) approach and (4) predictive modelling for early identification and management of exacerbations. During 2025, the novel service will be assessed using a Quintuple Aim approach. Moreover, the Consolidated Framework for Implementation Research will be applied to assess the implementation. The service components will be articulated through four sequential 6-month plan-do-study-act cycles. Each cycle involves a targeted cocreation process following a mixed-methods approach with the active participation of patients, health professionals, managers and digital experts.

Ethics and dissemination: The Ethics Committee for Human Research at Hospital Clinic de Barcelona approved the protocol on 29 June 2023 (HCB/2023/0126). Before any procedure, all patients in the study must sign an informed consent form.

Trial registration number: NCT06421402.

Keywords: Asthma; Patient Outcome Assessment; Pulmonary Disease, Chronic Obstructive; Respiratory Function Test; Surveys and Questionnaires; Telemedicine.

Figure 1. Study protocol flow chart: The four main components of the service are designed and assessed at the end of the first year. The second year, 2025, addresses evaluating the novel service following a Quintuple Aim approach and assessing the implementation process using the Comprehensive Framework for Implementation Research (CFIR). Throughout the protocol, four plan-do-study-act (PDSA) cocreation cycles, 6 months duration each, will be conducted with the participation of patients, health professionals, managers and digital experts. See text for detailed descriptions. AI, artificial intelligence; IAQ, indoor air quality; OAQ, outdoor air quality.

Figure 2. Enhanced patient management scheme: Patients participating in the digitally enabled follow-up will be overseen by a nurse case manager using the Health Circuit solution. The nurse schedules face-to-face visits at baseline for patient’s characterisation and every 6 months for follow-up. The nurse will be regularly in contact with the patients through the app’s communication channel (messages and/or video). Moreover, she can schedule face-to-face visits as needed depending on the evolution and requirements of the patient. The Health Circuit patient app offers a trimodal approach to data acquisition: (1) Biological data collection throughout the Beat One watch; (2) a chat channel for direct communication with the nurse case manager and (3) regular administration of health questionnaires to monitor disease status. Collected data through the Health Circuit app will be integrated into the study databases for comprehensive data analytics and predictive modelling. The Health Circuit professionals’ platform, controlled by the nurse case manager, provides enhanced patient management solutions. ACM, adaptive case management; KPI, key performance indicator; ML, machine learning.