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

NCT07482917 | Recruiting

• 1 other identifier: OPTIMIZE-ILD-1-HGG
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Keywords

Interstitial Lung Disease; ILD; Suspected ILD; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Connective Tissue Disease-ILD; IPF; Diagnostic Pathway; Diagnostic Delay; Multidisciplinary Discussion; One-Day ILD Clinic; Time to Diagnosis; Time to Treatment Initiation; Organizational Intervention; Health Services Research; Diagnostic Workflow Optimization; Patient Experience; Quality of Life; Pulmonary Function Tests; High-Resolution CT; Carbon Footprint

Outcome Measures

Primary Outcomes (1)

• Time to Diagnostic Communication

  Time (measured in days) elapsed from the date of randomization to the date when the final diagnosis is formally communicated to the patient. This measure captures the complete diagnostic process, including the scheduling and performance of all tests (imaging, PFTs, labs), the Multidisciplinary Team (MDT) consensus meeting, and the subsequent clinical appointment where the patient is informed of the findings and the initial management plan.

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

Secondary Outcomes (22)

• Time to Multidisciplinary Team (MDT) Diagnosis

  From randomization until the date of the MDT diagnostic consensus (up to 18 months).

• Time to Treatment Initiation

  From randomization until treatment initiation, if required (up to 18 months).

• Diagnostic Time Burden

  From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).

• Patient and Caregiver Socioeconomic Cost-Burden

  From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).

• Hospital Direct and Operational Costs

  From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).

Study Arms (2)

Standard ILD Diagnostic Pathway

ACTIVE COMPARATOR

Participants in this arm will follow the standard ILD diagnostic pathway. After referral for suspected ILD and confirmation of eligibility, 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, rheumatology or internal medicine assessment, or lung biopsy when indicated, are requested through usual clinical channels. These tests typically occur on different days. The final ILD diagnosis is assigned once all required results are available and reviewed in the ILD unit or in a multidisciplinary discussion when appropriate. The study team does not modify scheduling priorities, clinical decisions or the type of tests performed.

Other: Standard ILD Diagnostic Pathway

Optimized ILD Diagnostic Circuit

EXPERIMENTAL

Participants in this arm will follow a coordinated ILD diagnostic circuit in which the same core diagnostic procedures-high-resolution chest computed tomography, complete pulmonary function tests with spirometry and diffusing capacity, six-minute walk test and a comprehensive ILD laboratory panel-are pre-bundled and scheduled within a compressed and coordinated timeframe, in as few hospital visits as possible. When clinically indicated, additional evaluations such as bronchoscopy or rheumatology/internal medicine consultation are integrated into the same coordinated workflow. All available diagnostic information is reviewed in a single multidisciplinary discussion to assign the final ILD diagnosis and initial therapeutic plan. The intervention does not introduce new diagnostic tests, alter clinical content or modify prioritization rules; it reorganizes the timing and coordination of existing diagnostic steps to reduce fragmentation and diagnostic delays.

Other: Optimized ILD Diagnostic Circuit

Interventions

Standard ILD Diagnostic Pathway OTHER

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.

Standard ILD Diagnostic Pathway

Optimized ILD Diagnostic Circuit OTHER

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.

Optimized ILD Diagnostic Circuit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaume Bordas-Martinez, MD, PhD

  Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, consecutive, randomized, open-label, parallel-group clinical trial evaluating whether a coordinated diagnostic circuit reduces the time required to reach a confirmed ILD diagnosis compared with the standard diagnostic pathway. A total of 92 participants will be enrolled. Randomization is stratified 1:1:1 into three distinct groups: 1) patients referred from Primary Care, 2) patients referred from Specialized Care without a pre-existing autoimmune disease diagnosis, and 3) patients referred from Specialized Care with a pre-existing autoimmune disease diagnosis. Participants are included at first referral for suspected ILD prior to completion of a full diagnostic work-up.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 19, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary results and for a period of up to 5 years.
• Access Criteria: Access to IPD will be granted to researchers with a methodologically sound proposal and a clear scientific objective. Requests must be submitted to the Principal Investigator. Approval will require compliance with institutional data-protection policies, signing a data-use agreement, and ensuring secure data handling. No data containing personal identifiers will be provided.

Locations

ES (1)