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RECRUITING

NCT07482917

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

Sponsor: Hospital de Granollers

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-09

Completion Date

2028-03-01

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Interstitial Lung Disease (ILD)Suspected Interstitial Lung Disease Fibrotic Interstitial Lung Disease Idiopathic Pulmonary Fibrosis (IPF)Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)

Interventions

OTHER

Standard ILD Diagnostic Pathway

Organizational usual-care comparator following the standard ILD diagnostic workflow. After referral for suspected ILD, core diagnostic procedures such as high-resolution chest computed tomography, complete pulmonary function tests (spirometry and diffusing capacity), six-minute walk test, and a comprehensive ILD laboratory panel are ordered and scheduled independently according to routine departmental workflows and waiting times. Additional procedures, including bronchoscopy with bronchoalveolar lavage or rheumatology/internal medicine assessment, are requested when clinically indicated. These diagnostic tests and visits usually occur on separate days, and the final diagnosis is assigned once all required results are available and reviewed in the ILD unit or in a multidisciplinary discussion. The intervention does not modify clinical content, scheduling priorities, or the type of tests performed.

OTHER

Optimized ILD Diagnostic Circuit

Organizational intervention that coordinates and bundles core ILD diagnostic procedures into a compressed and structured workflow. For patients with suspected ILD, high-resolution chest computed tomography, complete pulmonary function tests (spirometry and diffusing capacity), the six-minute walk test, and a comprehensive ILD laboratory panel are pre-bundled and scheduled within a shortened timeframe, ideally within one or two coordinated visits. When required, bronchoscopy and rheumatology/internal medicine assessments are integrated into the same coordinated pathway. All available diagnostic results are reviewed in a single multidisciplinary discussion to assign the final ILD diagnosis and the initial therapeutic plan. The intervention does not introduce new tests or alter clinical decision-making; it reorganizes the timing and coordination of existing procedures without modifying waiting-list rules.

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.

Locations (1)

Hospital General de Granollers

Granollers, Barcelona, Spain