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.
Age 18 years or older.
Referral for suspected or undiagnosed interstitial lung disease (ILD).
A finding suggestive of ILD (such as reticulation, ground-glass opacities, traction bronchiectasis or honeycombing) not attributable to another disease, on a CT available at referral that includes the lung parenchyma, regardless of its indication; or
Persistent or progressive shortness of breath or chronic cough not attributable to another disease, accompanied by at least one of the following: an interstitial or reticular pattern on chest radiograph; reduced forced vital capacity; persistent bibasilar crackles or digital clubbing; a relevant environmental or occupational exposure, autoimmune disease, or suspected drug or radiation toxicity; or a first-degree family history of ILD.
Complete ILD diagnostic work-up already performed (chest CT plus full pulmonary function testing including six-minute walk test plus complete ILD laboratory panel).
Established diagnosis of ILD previously assigned by another center or specialist.
Clinical instability or acute illness that would prevent reliable completion of diagnostic procedures (e.g., respiratory infection, suspected acute ILD exacerbation, acute heart failure).
Acute iatrogenic pneumonitis (drug-, chemotherapy- or radiation-induced) with a clear temporal relationship to the offending agent.
Parallel
Standard ILD Diagnostic Pathway
Other interventionOrganizational 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.
Optimized ILD Diagnostic Circuit
Other interventionOrganizational 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.
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.
Time to Multidisciplinary Team (MDT) Diagnosis
Time elapsed from the randomization to the date of the multidisciplinary team (MDT) meeting where a final diagnostic consensus is reached. This measure evaluates the internal efficiency of the clinical work-up and the diagnostic decision-making process prior to patient communication.
Time to Treatment Initiation
Time elapsed from the randomization to the date of initiation of the first pharmacological or non-pharmacological treatment. This measure will be calculated only for participants for whom treatment is clinically indicated according to the multidisciplinary team (MDT) consensus.
Diagnostic Time Burden
Total time required for the patient and caregivers to complete the diagnostic work-up (Home-to-Home), including the cumulative time spent travelling from home to the hospital and back for all diagnostic visits, as well as the cumulative in-hospital time needed to complete scheduled tests, evaluations and procedures.
Patient and Caregiver Socioeconomic Cost-Burden
This outcome assesses the private economic impact and "Financial Toxicity" on the family unit. It evaluates: 1. Direct Non-Medical Costs: Private expenses related to transportation, parking, and logistics required for hospital attendance. 2. Indirect Costs (Productivity Loss): Economic value of the time dedicated to the diagnostic process by both the patient and the primary caregiver, including work absenteeism and disruption of daily obligations. 3. Caregiver Burden: Impact on the support network, analyzed to identify potential gender gaps in caregiving. Data is expressed in Euros (€). Higher values indicate a greater socioeconomic burden and higher "Time Burden" imposed by the diagnostic circuit.
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