The OPTIMIZE-ILD-2 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated follow-up pathway on patients with established interstitial lung disease (ILD). In routine clinical practice, follow-up workflows for ILD are frequently fragmented, requiring multiple hospital visits for pulmonary function tests, laboratory analysis, treatment administration, and consultations with various specialists, which increases the burden for both patients and caregivers. This study compares the standard follow-up care against an optimized circuit where all routine monitoring procedures and interdisciplinary consultations are pre-bundled and scheduled within a single, coordinated hospital visit.
All eligible patients under active ILD follow-up are included consecutively to ensure a pragmatic, real-world representation of the treated ILD population. The primary objective is to measure the total follow-up time burden, defined as the total home-to-home time required to complete the follow-up circuit. As a cross-sectional assessment within a longitudinal context, secondary objectives include assessing socioeconomic cost-burden, the environmental carbon footprint of the follow-up journey, health-related quality of life, and clinical frailty. Caregiver-related outcomes, including burden and experience measures, are contingent upon the presence of a primary caregiver and the provision of their independent informed consent.
The design of this protocol was informed by a patient focus group and is officially endorsed by the 'AIRE' Associació Catalana de Malalts i Trasplantats Pulmonars, ensuring a patient-centered approach that prioritizes follow-up efficiency and human impact.
Age ≥ 18 years.
Established diagnosis of interstitial lung disease (ILD).
Currently receiving antifibrotic therapy, immunosuppressive therapy, or both, as part of routine ILD care.
Under active follow-up at the participating ILD center.
Inability to complete the coordinated follow-up visit for non-medical reasons (e.g., logistical impossibility).
Clinical instability or acute illness interfering with planned follow-up procedures (such as respiratory infection, suspected ILD exacerbation, acute heart failure, or other acute conditions).
Participation in another interventional clinical trial that may alter visit frequency or follow-up structure.
Cognitive impairment preventing informed consent or completion of questionnaires.
Parallel
Standard ILD Follow-Up Pathway
Other interventionOrganizational usual-care comparator consisting of the standard ILD follow-up pathway. For patients with established ILD receiving antifibrotic and/or immunosuppressive therapy, follow-up components such as pulmonary function tests, 6-minute walk test when performed, laboratory monitoring, imaging when indicated, pharmacy visits, nursing assessments, and medical consultations are requested and scheduled independently by each department according to routine workflows and waiting times. These procedures usually occur on separate days, and a full follow-up cycle frequently requires multiple hospital visits. The study team does not alter scheduling priorities, clinical decisions, or the type of tests performed.
Optimized One-Day ILD Follow-Up Circuit
Other interventionOrganizational intervention that coordinates and bundles all required ILD follow-up procedures into a single structured "one-day" visit. For patients with established ILD on antifibrotic and/or immunosuppressive therapy, the intervention pre-schedules pulmonary function tests, laboratory monitoring, imaging when indicated, pharmacy consultation, nursing assessment, and medical visits within the same day. When clinically necessary, rheumatology or internal medicine consultations are integrated into the same coordinated circuit. The intervention does not introduce new tests or treatments and does not modify hospital waiting-list rules; it only reorganizes the timing and consolidation of existing follow-up procedures to reduce overall time burden.
Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time)
Total time spent by the participant to complete the ILD follow-up cycle, defined as the sum of: (a) home-to-hospital and hospital-to-home travel time required for the follow-up visit, and (b) in-hospital time required to complete all scheduled tests, consultations and procedures. Time will be recorded in hours using a structured case report form and a standardized patient interview. Each participant will undergo one comprehensive follow-up assessment within the predefined follow-up cycle.
Patient and Caregiver Socioeconomic Cost-Burden
This outcome assesses the private economic impact and "Financial Toxicity" on the family unit. It evaluates: 1. Direct Non-Medical Costs: Private expenses related to transportation, parking, and logistics required for hospital attendance. 2. Indirect Costs (Productivity Loss): Economic value of the time dedicated to the monitoring process by both the patient and the primary caregiver, including work absenteeism and disruption of daily obligations. 3. Caregiver Burden: Impact on the support network, analyzed to identify potential gender gaps in caregiving. Data is expressed in Euros (€). Higher values indicate a greater socioeconomic burden and higher "Time Burden" imposed by the follow-up circuit.
Hospital Direct and Operational Costs
This measure calculates the total economic impact on the healthcare system during the follow-up pathway. It includes: 1. Direct Clinical Costs: Outpatient visits, multidisciplinary committee reviews, and monitoring tests (CT scans, lung function tests, and biopsies) based on standard hospital billing rates. 2. Operational Costs: Administrative staff time dedicated to the coordination and scheduling of the circuit. 3. Inefficiency Costs: Opportunity costs derived from non-attended appointments (no-shows), missed or incomplete follow-up procedures requiring rescheduling, and unscheduled emergency visits. All values are calculated in Euros (€). Higher scores indicate higher healthcare resource utilization and lower operational efficiency
Carbon Footprint of the ILD Follow-Up Pathway
Estimated CO₂-equivalent emissions generated by patient and caregiver travel and healthcare resource use during the follow-up cycle. Emissions are calculated from reported travel distance, transport mode and number of companions using validated emission factors.
EQ-5D-5L Health-Related Quality of Life Questionnaire
The EQ-5D-5L is a standardized instrument for measuring generic health status. It consists of a descriptive system covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ Visual Analogue Scale (EQ-VAS). The 5 dimensions are scored on 5 levels (1=no problems to 5=extreme problems). The EQ-VAS records the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). Results are reported as an index score (ranging from \<0 to 1, where 1 is perfect health) and the VAS score. Higher scores in the index and VAS indicate better quality of life.
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