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

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)

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.

Sponsors & Collaborators

• Hospital de Granollers

  lead OTHER

Principal Investigators

• Jaume Bordas-Martinez, MD, PhD · Hospital General de Granollers

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-09

Primary Completion

2028-03-01

Completion

2028-03-01

Countries

• Spain

Study Locations