Actively Recruiting
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Led by Hospital de Granollers · Updated on 2026-04-09
92
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing the Diagnostic Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-1 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Referral for suspected or undiagnosed interstitial lung disease (ILD).
- Incomplete ILD diagnostic work-up at the time of referral (previous chest CT or partial blood tests allowed, but not complete lung function testing or full ILD lab panel).
- At least one radiological sign suggestive of ILD on chest X-ray or CT not explained by other diseases.
- At least one lung function abnormality compatible with ILD not explained by other diseases.
- At least one physical exam finding suggestive of ILD (persistent bibasilar crackles or digital clubbing) not explained by other diseases.
- Symptoms like persistent or progressive shortness of breath or chronic cough only when combined with radiological, functional, or clinical signs above.
- History of relevant environmental or occupational exposure, autoimmune disease, or suspected drug/radiation toxicity only when combined with radiological, functional, or clinical signs above.
- Family history of ILD in a first-degree relative only when combined with radiological, functional, or clinical signs above.
- Ability to provide informed consent.
You will not qualify if you...
- Complete ILD diagnostic work-up already performed (chest CT plus full lung function tests including six-minute walk test plus complete ILD lab panel).
- Established ILD diagnosis previously assigned by another center or specialist.
- Clinical instability or acute illness preventing reliable completion of diagnostic procedures (including respiratory infection, acute ILD exacerbation, acute heart failure, or other acute conditions).
- Medical, functional, psychiatric, or logistical limitations interfering with diagnosis or data collection as judged by investigators.
- Participation in another interventional clinical trial affecting diagnostic procedure timing.
- Cognitive impairment preventing informed consent or completion of questionnaires.
- Refusal to participate or refusal to allow collection/use of clinical data.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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