The study protocol is part of the European (EU) project "Knowledge for improving indoor AIR quality and HEALTH" (K-HEALTHinAIR, 2022-2026 - registry 101057693), which focuses on enhancing our understanding of how poor indoor air quality (IAQ) affects human health. Specifically, the project aims to identify IAQ determinants of adverse health events and to explore the development of cost-effective strategies for the precise monitoring and improvement, of IAQ across Europe. With the current study protocol, the Barcelona Pilot, at the Integrated Health District of Barcelona-Esquerra (AISBE, 520 k citizens), is conducting a cohort study over a two-year period (January 2024 to December 2025) to explore the relationships between IAQ (assessment of chemical pollutants in patients' homes) and health status (acute episodes) in multimorbid patients with chronic respiratory diseases (asthma and Chronic Obstructive Pulmonary Disease - COPD) over a two-year period. The protocol investigates the effectiveness of customized interventions across four critical areas: i) Advanced lung function testing, ii) Continuous IAQ monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modeling for early identification and management of exacerbations. The ultimate objective is to design and evaluate an innovative integrated care service aiming at enhancing both IAQ and the management of multimorbid patients with chronic obstructive respiratory diseases, with focus on COPD and severe asthma.
The study is structured as a comprehensive two-phase approach. From January to December 2024 (Phase I) the protocol focuses on the assessment, and refinement, of the four core components of the study: i) Enhanced lung function testing, ii) IAQ home monitoring, iii) Advanced digital support to innovative clinical processes, and iv) Predictive modelling for early detection and management of exacerbations. The main outcome at the end of Phase I is the design of an innovative integrated care service aiming at enhanced management of exacerbations and reduction of unplanned hospitalizations in high-risk patients. From January to December 2025 (Phase II), the protocol aims to refine the novel clinical process, including the four core components alluded to above, as well as to evaluate the potential for healthcare value generation and scalability/transferability of the new integrated care service. PHASE I (2024): 1. Enhanced Lung Function Testing: Adoption of oscillometry (forced oscillation technique) to measure respiratory system resistance and reactance, as a complementary tool of forced spirometry, exploring its potential for patients' monitoring and management of exacerbations. 2. Continuous Monitoring of IAQ at patients' homes: Assessment of advanced monitoring systems in patients' homes to continuously track air quality parameters, enabling the identification of environmental triggers linked to respiratory exacerbations. 3. Advanced Digital Support to innovative clinical processes with a two-fold aim: i) patient's empowerment for self-management of his/her condition, and ii) enhancing the role of the nurse case manager for early detection and management of exacerbations promoting share care agreements between the patient and the reference doctor (primary care physician and/or specialist). To this end, adoption of an Adaptive Case Management (ACM) Approach constitutes a key element. 4. Predictive Modeling: Development, and refinement, of machine learning-based modelling for early detection and management exacerbations. Key input data in the modelling approach will be: i) Clinical information (symptoms, Patient Reported Outcome Measures - PROMs), ii) Lung function testing, and iii) Patient's self-capturing physiological data through wrist sensors (health rate, heart rate variability and physical activity). Moreover, the impact of IAQ monitoring in the modelling will be explored. The implementation, and refinement, of the four components alluded to above, as well as the design of the novel integrated care service, will be done with active engagement of patients, healthcare professionals, and other stakeholders in a co-design process using the Plan-Do-Study-Act (PDSA) methodology. Two PDSA cycles, with a six-month duration each, will be undertaken during 2024. PHASE II (2025): From January to December 2025, two additional PDSA cycles (six-month duration each) are planned to cover the following objectives: 1. Refinement of the novel integrated care service for enhanced management of exacerbations, as well as the implementation and continuous assessment of the four core components described in PHASE I. 2. Assessment of the outcomes of the novel integrated care service using the Quintuple Aim framework, that is, considering: i) Healthcare outcomes, ii) PROMs/Patient Reported Expirence Measures (PREMs), iii) healthcare professionals' engagement, iv) operational costs, and v) assessing equity. Comparison with conventional care will be done using a propensity score matching to elaborate a control group. 3. Evaluation of the process of deployment of the service using the Consolidated Framework for Implementation Research (CFIR) to identify barriers/facilitators for achieving a sustainable adoption, target candidates for the novel service, as well as potential for service transferability to other sites. At the end of PHASE II, a mature service design ready for adoption should be available. Besides fulfilment of the objectives of K-Health in Air, the key lessons learned in the two-years period should provide novel insights for enhanced management of chronic patients with multimorbid conditions. (Enclosed find: i) the Patient's Informed Consent approved by the Ethics Committee, as well as ii) the study protocol approved by the Ethics Committee of the Hosptial Clínic de Barcelona (HCB-2023-0126)).
Study Type
OBSERVATIONAL
Enrollment
200
Indoor Air Quality: \- MICA-INBIOT system: temperature (ºC), humidity (%), CO2 (ppm), total Volatile Organic Ccompounds (VOCs) (ppb), Formaldehyde (µg/m3); and Particulate Matter (PM) 1/2.5/4/10 (µg/m3) Outdoor Air Quality: \- Aeris Weather platform: NO, NO2, NOx, SO2, SO3, CO, and PM10, all expressed in µg/m3
General surveys: * PROMs: ICHOM Adult Set; encompassing Patient Reported Outcomes Measurement Information System (PROMIS 10), World Health Organization Wellbeing Index (WHO 5) and World Health Organization Disability Assessment Schedule (WHO-DAS 12) questionnaires. * PREMs: Patient-Reported Indicator Survey (PaRIS) Disease specific questionaires: * COPD: COPD Assessment Test (CAT); modified Medical Research Council (mMRC) Dyspnea scale. * Asthma: Asthma Control Test (ACT); Test of Adherence to Inhalers (TAI-12); Asthma Quality of Life Questionnaire (mini AQLQ); Sino-Nasal Outcome Test (SNOT-22).
* Forced Spirometry: Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) * Forced Oscillation Technique: Impedance, resistance and reactance. Ancillary measurements: Systemic arterial pressure and pulse oximetry.
Electronic Medical Records (EMRs): Updated every twelve months to track clinical events from Hospital and Primary Care databases. Registry data: from the Catalan Health Surveillance System (CHSS).
Health Circuit: chat, short questionnaires (Likert scale). As needed.
Enhanced with real-time physiological data tracking (heart rate, steps walked and Heart Rate Variability (HRV))
Mobile App Health Circuit: follow-up of the personalized action plan agreed with the patient \& reference doctor
Health Circuit: home-based oscillometry, daily disease-specific questionnaire during the acute episode and continuous assessment of physiological variables.
Fundació de Recerca Clínic Barcelona - Institut d'Investigació Biomèdica August Pi I Sunyer (FRCB-IDIBAPS)
Barcelona, Spain
Changes in use of healthcare resources - Unplanned hospital admissions
Number of unplanned hospital admissions. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Changes in use of healthcare resources - Exacerbations
Number and severity of exacerbations. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Changes in use of healthcare resources - Emergency room visits
Number of emergency room visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Changes in use of healthcare resources - Primary care visits.
Number of primary care visits. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Healthcare costs
Healthcare costs in € This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Patient reported experience (PREMs) - Enjoyment of life
Enjoyment of life: ICEpop CAPability measure for Older people (ICECAP-O) Scored on a scale from 0 to 1, where 0 represents no capability and 1 represents full capability. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Resilience
Resilience: Brief Resilience Scale (BRS) Scores range from 1 to 5, with higher scores indicating greater resilience. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Physical functioning
Physical functioning: 36-Item Short Form Survey (SF-36) Scores range from 0 to 100, where a higher score indicates better health status. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Continuity of care
Continuity of care: Nijmegen Continuity Questionnaire (NCQ) Scores ranging on a Likert scale from 1 to 5. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Physiological wellbeing
Physiological wellbeing: Mental Health Inventory-5 (MHI-5) Scored on a scale of 0 to 100, where higher scores indicate better mental health. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Social Participation
Social Participation: Impact on Participation and Autonomy (IPA) Uses a scoring system based on a Likert scale ranging from 0 to 4 where higher scores indicate greater impairment in participation and autonomy. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported experience (PREMs) - Person-centeredness
Person-centeredness: Patient Perceptions of Patient-Centeredness Questionnaire (P3CEQ) Typically uses a Likert scale from 1 to 5, with higher scores indicating better perceptions of patient-centeredness. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group.
Time frame: During 2025
Patient reported outcomes (PROMs) - Asthma symptoms
Asthma symptoms: Asthma Control Test (ACT) 5 questions, each scored from 1 (poor control of asthma) to 5 (complete control of asthma). Higher scores indicate better asthma control. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Patient reported outcomes (PROMs) - Functional problems related to asthma
Functional problems related to asthma: Asthma Quality of Life Questionnaire (miniAQLQ) Designed to measure the functional problems (physical, emotional, social, and occupational) that are most troublesome to adults with asthma. It includes a series of questions scored from 1 (maximum impairment) to 7 (no impairment), with higher scores indicating better quality of life. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Patient reported outcomes (PROMs) - COPD symptoms
COPD symptoms: COPD Assessment Test (CAT) Each question is scored from 0 (no impact) to 5 (maximum impact), with the total score ranging from 0 (less impact) to 40 (more impact), indicating the severity of COPD. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Patient reported outcomes (PROMs) - Dyspnea
Dyspnea: Modified Medical Research Council (mMRC) Dyspnea Scale. It ranges from 0 (no breathlessness except with strenuous exercise) to 4 (too breathless to leave the house or breathless when dressing/undressing), with higher scores indicating more severe dyspnea. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Patient reported outcomes (PROMs) - Sino-Nasal symptoms
Sino-Nasal symptoms: Sino-Nasal Outcome Test (SNOT-22) 22 items, each scored from 0 (no problem) to 5 (problem as bad as it can be). The total score can thus range from 0 (no sinus-related health problems) to 110 (severe sinus-related health problems). This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Patient reported outcomes (PROMs) - Adherence to inhalers
Adherence to inhalers: Test of Adherence to Inhalers (TAI-12) 12-item questionnaire used to assess a patient's adherence to inhaler medication in respiratory diseases. Each item is scored on a 5-point scale, with higher scores indicating better adherence. The total score ranges from 12 (poor adherence) to 60 (excellent adherence). This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. It will be collected across the entire intervention group and in a randomly selected subset of 50 patients from the control group. \*Depending on whether the primary disorder is asthma or COPD
Time frame: During 2025
Equity of the intervention
Access to the service across different population groups: age, ethnicity, gender, socioeconomic status. This outcome is part of a Quintuple Aim assessment of healthcare value generation of the novel integrated care service. Assessed in all individuals
Time frame: During 2025
Performance of Predictive Modeling for Enhanced Management of Exacerbations
Model accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic (ROC) curve
Time frame: During 2025
Performance of the digital support in terms of robustness and usability - Customer Satisfaction
Customer Satisfaction: Net Promoter Score (NPS) Measures customer loyalty and satisfaction. It is derived from asking customers a single question on a 0-10 scale Assessed in the intervention group only.
Time frame: During 2025
Performance of the digital support in terms of robustness and usability - Usability
Usability: System Usability Scale (SUS) Scored on a scale of 0 to 100, scores above 80 is an indicator of excellent usability, while a score below 60 could be problematic and suggests that the design needs improvements. Assessed in the intervention group only.
Time frame: During 2025
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