Optimizing the diagnostic journey in interstitial lung disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

OPTIMIZE-ILD-1 is a single-center, prospective, randomized, open-label trial comparing the usual fragmented diagnostic pathway to an optimized, coordinated circuit that pre-bundles core tests such as high-resolution chest CT, complete pulmonary function tests, and laboratory panels. Eligible consecutive adult referrals with suspected or undiagnosed ILD are randomized 1:1, with stratification into three referral source groups to balance entry routes and phenotypes. The intervention compresses scheduling to complete necessary diagnostics in the minimum number of hospital visits without changing the clinical content or prioritization rules. The primary endpoint is time to diagnostic communication after multidisciplinary team consensus, with secondary outcomes including time to MDT diagnosis, time to treatment initiation, and socioeconomic cost burden for the family unit.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 years or older.
* Referral for suspected or undiagnosed interstitial lung disease (ILD).
* At least one of the following:

  * A finding suggestive of ILD (such as reticulation, ground-glass opacities, traction bronchiectasis or honeycombing) not attributable to another disease, on a CT available at referral that includes the lung parenchyma, regardless of its indication; or
  * Persistent or progressive shortness of breath or chronic cough not attributable to another disease, accompanied by at least one of the following: an interstitial or reticular pattern on chest radiograph; reduced forced vital capacity; persistent bibasilar crackles or digital clubbing; a relevant environmental or occupational exposure, autoimmune disease, or suspected drug or radiation toxicity; or a first-degree family history of ILD.
* Ability to provide informed consent.

Exclusion Criteria:

* Complete ILD diagnostic work-up already performed (chest CT plus full pulmonary function testing including six-minute walk test plus complete ILD laboratory panel).
* Established diagnosis of ILD previously assigned by another center or specialist.
* Clinical instability or acute illness that would prevent reliable completion of diagnostic procedures (e.g., respiratory infection, suspected acute ILD exacerbation, acute heart failure).
* Acute iatrogenic pneumonitis (drug-, chemotherapy- or radiation-induced) with a clear temporal relationship to the offending agent.
* Medical, functional, psychiatric or logistical limitations that, in the investigators' opinion, would interfere with the diagnostic process or data collection.
* Participation in another interventional clinical trial that may alter the frequency or timing of diagnostic procedures.
* Cognitive impairment that prevents informed consent or completion of study questionnaires.
* Refusal to participate or to allow the collection or use of clinical data.

Where it's running

• Hospital General de Granollers
  Granollers, Barcelona, Spain Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.