Streamlined follow-up care for people with interstitial lung disease

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

This study tests whether bundling all routine ILD monitoring into a single coordinated one-day visit cuts the total time patients on antifibrotic and/or immunosuppressive treatment spend away from home.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 152 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital de Granollers (Academic / other)
• Locations: 1 site (Granollers, Barcelona)
• Trial ID: NCT07486206 on ClinicalTrials.gov

What this trial studies

OPTIMIZE-ILD-2 is a single-center, prospective, randomized, open-label trial that compares usual fragmented follow-up with a coordinated one-day monitoring circuit for patients with established ILD. Eligible patients under active follow-up are enrolled consecutively and randomized 1:1, with stratification by treatment regimen (antifibrotic, immunosuppressive, or both) to balance monitoring complexity. The primary endpoint is the home-to-home time required to complete scheduled monitoring, and secondary outcomes include operational resource use and economic efficiency. The intervention does not change clinical content but reorganizes scheduling to complete pulmonary function tests, labs, imaging, treatments, and multidisciplinary consultations in the minimum number of hospital visits possible.

Who should consider this trial

Good fit: Adults (≥18) with an established ILD who are under active follow-up at the participating center and receiving antifibrotic therapy, immunosuppressive therapy, or both, and who can attend and consent to the coordinated visit are ideal candidates.

Not a fit: Patients who are clinically unstable, acutely ill, unable to attend for logistical reasons, cognitively unable to consent, or enrolled in another interventional protocol that modifies visit schedules are unlikely to benefit from the coordinated pathway.

Why it matters

Potential benefit: If successful, this approach could substantially reduce travel time and scheduling burden for patients and caregivers while improving access equity.

How similar studies have performed: One-stop or coordinated clinic models in other chronic diseases have shown improved convenience and efficiency, but a bundled ILD monitoring pathway of this exact design is relatively novel with limited direct evidence.

Eligibility criteria

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.

Where this trial is running

Granollers, Barcelona

• Hospital General de Granollers — Granollers, Barcelona, Spain (Recruiting)

Study contacts

• Principal investigator: Jaume Bordas-Martinez, MD, PhD — Hospital General de Granollers

Conditions Interstitial Lung Disease; Fibrotic Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis; Interstitial Lung Disease Due to Connective Tissue Disease; ILD; Pulmonary Fibrosis; CTD-ILD