RECRUITINGINTERVENTIONAL

Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial

OPTIMIZE-ILD-2: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Coordinated Follow-Up Circuit on Time Burden in Patients With Interstitial Lung Disease

About This Trial

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. 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - Able to attend the required follow-up procedures included in the study visit. - Able to provide willing to sign a consent form. Who Should NOT Join This Trial: - 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 willing to sign a consent form or completion of questionnaires. - Patient refusal to participate or refusal to allow data collection. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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. * Able to attend the required follow-up procedures included in the study visit. * Able to provide informed consent. Exclusion Criteria: * 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. * Patient refusal to participate or refusal to allow data collection.

Treatments Being Tested

OTHER

Standard ILD Follow-Up Pathway

Organizational 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.

OTHER

Optimized One-Day ILD Follow-Up Circuit

Organizational 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.

Locations (1)

Hospital General de Granollers

Granollers, Barcelona, Spain