RecruitingNot Applicable

Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial

Spain92 participantsStarted 2026-03-09

Plain-language summary

The OPTIMIZE-ILD-1 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated diagnostic pathway on patients with suspected interstitial lung disease (ILD). In routine clinical practice, diagnostic workflows for ILD are frequently fragmented, involving multiple independent appointments that can lead to significant delays and increased burden for patients and caregivers. This study compares the standard diagnostic pathway against an optimized circuit where core diagnostic procedures-such as high-resolution CT, pulmonary function tests, and laboratory panels-are pre-bundled and scheduled within a coordinated and compressed timeframe. All eligible patients referred for suspected ILD are included consecutively to ensure a pragmatic, real-world representation of the referral population. The primary objective is to measure the time to diagnostic communication, defined as the duration from randomization to the date the patient is formally informed of the final diagnosis following a multidisciplinary team (MDT) consensus. Secondary objectives include assessing the time to MDT diagnosis, the time to treatment initiation (when clinically indicated), socioeconomic cost-burden, and the environmental carbon footprint of the diagnostic journey. Furthermore, the study evaluates health-related quality of life, psychological distress, and clinical frailty, while exploring factors such as language proficiency as determinants of diagnostic equity. 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 the diagnostic journey's efficiency and human impact.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 years or older. * Referral for suspected or undiagnosed interstitial lung disease (ILD). * Incomplete interstitial lung disease diagnostic work-up at the time of referral (previous chest computed tomography or partial blood tests allowed, but not complete pulmonary function testing or the full ILD diagnostic laboratory panel). * Presence of at least one radiological finding suggestive of interstitial lung disease on chest X-ray or chest computed tomography (including reticulation, ground-glass opacities, traction bronchiectasis or honeycombing) that cannot be explained by other diseases. * Presence of at least one functional abnormality compatible with interstitial lung disease (reduced forced vital capacity or reduced diffusing capacity for carbon monoxide) that cannot be explained by other diseases. * Presence of at least one physical examination finding suggestive of interstitial lung disease (persistent bibasilar crackles or digital clubbing) that cannot be explained by other diseases. * Presence of symptoms such as persistent or progressive shortness of breath or chronic cough, only when accompanied by at least one radiological, functional or semiological criterion above. * History of relevant environmental exposure, occupational exposure, autoimmune disease, or suspected drug or radiation toxicity, only when accompanied by at least one radiological, functional or semiological criterion above. * Family history of interstitial lung disease in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Diagnostic Communication

Timeframe: From randomization until the date of diagnostic communication to the patient (up to 18 months).

Trial details

NCT IDNCT07482917

SponsorHospital de Granollers

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

View on ClinicalTrials.gov More Interstitial Lung Disease (ILD) trials