ABSTRACT

Background Community-based management of exacerbations in high-risk chronic obstructive respiratory patients remains a major challenge due to patients’ heterogeneities, co-morbidities and symptoms-based assessment of the episodes. Hybrid care interventions—combining digital tools with in-person, patient-centered care—have demonstrated efficacy in reducing unplanned hospitalizations. However, their effectiveness in real-world settings is less well established.

Objectives To report the co-design process aiming to (1) characterize target candidates; and (2) adapt the implementation of a hybrid care intervention to routine clinical practice.

Methods In the Integrated Health District of Barcelona-Esquerra (520 k citizens), three Plan-Do-Study-Act (PDSA) co-design cycles, each lasting six months, were conducted using a mixed-methods approach during a two-year follow-up (2024–2025) of a cohort of 205 patients with chronic obstructive pulmonary disease (COPD) and co-morbidities or severe asthma.

Results By the end of PDSA cycle 3 (August 2025), profiles of high-risk candidates for the hybrid care intervention were identified. The specificities of the three intertwined components of the intervention: i) health risk assessment, ii) advanced digital support, and iii) nurse-led in person care were defined. Home-based, patient’s self-administered Oscillometry proved useful for the objective assessment and management of exacerbations. Adapting the implementation of the hybrid care intervention to local clinical workflows was identified as a priority to enable its sustainable adoption.

Conclusions A personalized hybrid care intervention appears suitable for the management of heterogeneous high-risk respiratory patients. Ongoing tailored implementation during PDSA cycle 4, until February 2026, will be key for its scale up and sustainable adoption.

Trial registration number NCT06421402.

Competing Interest Statement

IC and JR hold shares in Health Circuit SL. JR contributes to the Astra-Zeneca Global Oscillometry Advisory Board. All other authors declare no conflicts of interest.

Clinical Trial

NCT06421402

Funding Statement

The K-HEALTHinAIR project funded this study, Grant Agreement n 101057693, under a European Union Call on Environment and Health (HORIZON-HLTH-2021-ENVHLTH-02). This research was also supported by the Catalan Government and the Catalan Department of Research and Universities under contract 2021 SGR 00326.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for the process evaluation was granted by the Ethical Committee for Human Research at the Hospital Clinic de Barcelona on June 29, 2023 (HCB/2023/0126) and registered at ClinicalTrials.gov (NCT06421402). The patients participating in the research were required to provide and sign a written informed consent indicating the purpose of the study, the nature, use and management of their data.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

AbbreviationsACMAdaptive Case ManagementAISBEIntegrated Health District of Barcelona-EsquerraAMGAdjusted Morbidity GroupsCATCOPD Assessment TestCHSSCatalan Health Surveillance SystemCOPDChronic Obstructive Pulmonary DiseaseGRAMMSGood Reporting of a Mixed-Methods StudyEUEuropean UnionFEV1Forced Expiratory Volume in 1 secondFEV1/FVCRatio of FEV1 to FVCFVCForced Vital CapacityGenAIGenerative Artificial IntelligenceHCBHospital Clínic de BarcelonaHRHeart RateHRVHeart Rate VariabilityIAQIndoor Air QualityITInformation TechnologyITFITSIntegrated Theory-based Framework for Intervention Tailoring StrategiesI-STEMImplementation Stakeholder Engagement ModelKPIKey Performance IndicatorLCSLow-Cost SensorsMLMachine LearningmMRCModified Medical Research Council Dyspnoea ScalePCAPrincipal Component AnalysisPDSAPlan-Do-Study-ActPMParticulate MatterPREMsPatient Reported Experiences MeasuresPROMsPatient Reported Outcomes MeasuresRCTRandomized Controlled TrialSDStandard DeviationVOCVolatile Organic Compounds.