Optimizing the diagnostic journey in interstitial lung disease

OPTIMIZE-ILD-1: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Diagnostic Circuit on Time to Diagnosis in Patients With Suspected Interstitial Lung Disease

This trial tests whether bundling core tests and coordinating appointments can speed up diagnosis for adults referred with suspected interstitial lung disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospital de Granollers (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Granollers, Barcelona)
• Trial ID: NCT07482917 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) referred for suspected or undiagnosed ILD who do not yet have a complete ILD work-up and have at least one radiologic, functional, or physical finding compatible with ILD.

Not a fit: Patients who already have a complete ILD diagnostic work-up, who require specialized tests outside the bundled pathway, or who cannot attend the single-center visits are unlikely to benefit from the intervention.

Why it matters

Potential benefit: If successful, patients could receive a formal ILD diagnosis more quickly with fewer hospital visits and less caregiver burden, enabling earlier treatment discussions when needed.

How similar studies have performed: Coordinated or 'one-stop' diagnostic pathways have shortened time to diagnosis in other specialties and some lung services, but randomized evidence specifically in ILD remains limited.

Eligibility criteria

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 a first-degree relative, only when accompanied by at least one radiological, functional or semiological criterion above.
* Ability to provide informed consent.

Exclusion Criteria:

* Complete interstitial lung disease diagnostic work-up already performed (chest computed tomography plus full pulmonary function testing including six-minute walk test plus complete interstitial lung disease laboratory panel).
* Established diagnosis of interstitial lung disease previously assigned by another center or specialist.
* Clinical instability or acute illness that would prevent reliable completion of diagnostic procedures (including respiratory infection, suspected acute exacerbation of interstitial lung disease, acute heart failure or other relevant acute conditions).
* Medical, functional, psychiatric or logistical limitations that, in the opinion of the investigators, 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 the ability to provide informed consent or complete study questionnaires.
* Refusal to participate or refusal to allow the collection or use of clinical data.

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; Suspected Interstitial Lung Disease; Fibrotic Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Interstitial Lung Disease Due to Connective Tissue Disease; ILD; Suspected ILD; Pulmonary Fibrosis