Description

The primary endpoint of this study is the time to diagnostic communication, defined as the interval from randomization to the date when the final diagnosis is formally communicated to the patient following multidisciplinary team (MDT) consensus. Interstitial lung diseases (ILD) require a complex, multidimensional evaluation involving radiology, pulmonary function testing, and clinical assessment; however, fragmented scheduling in routine care often delays diagnosis and exacerbates inequities. OPTIMIZE-ILD-1 is a single-center, prospective, randomized trial with 1:1 allocation.

To ensure a balanced representation of clinical entry routes and phenotypes, randomization is stratified 1:1:1 into three distinct groups: 1) referrals from Primary Care, 2) referrals from Specialized Care without a pre-existing autoimmune disease, and 3) referrals from Specialized Care with a pre-existing autoimmune disease. The intervention streamlines the coordination of existing diagnostic steps-including high-resolution chest CT, complete pulmonary function tests, and comprehensive laboratory panels-by clustering them into a coordinated workflow designed to be completed in the minimum number of hospital visits possible, without modifying clinical content or prioritization rules.

Secondary outcomes evaluate the pathway's efficiency and economic impact, including time to MDT diagnosis, time to treatment initiation (where clinically indicated), and the socioeconomic cost-burden for the family unit, which accounts for direct logistical expenses, productivity loss, and hospital operational inefficiencies. Additionally, the environmental impact is quantified via the diagnostic journey's carbon footprint. Patient-centered metrics are captured through validated instruments: EQ-5D-5L and K-BILD for health-related quality of life; GAD-7 for anxiety and PHQ-9 for depression; the Oslo-3 Social Support Scale for perceived social support; the Gijon Scale for social risk; and the CFS for clinical frailty. Caregiver burden (Caregiver Burden Inventory, CBI-15) and family experience measures (PREMs) are assessed contingent upon the presence of a primary caregiver and the provision of their independent informed consent. Satisfaction and process quality are further monitored using study-specific PREMs for patients, caregivers, and interdisciplinary professionals. A Patient Global Impression of Change (PGIC) is collected at the end of the study for patients, caregivers, and professionals to anchor the clinical significance of observed changes. A study-specific social work screening questionnaire is administered to identify patients with unmet social needs who may benefit from social work referral.

Finally, the study includes a pre-planned exploratory analysis to evaluate the equity of the intervention's impact across diverse populations. This analysis will investigate whether sociodemographic determinants-primarily socioeconomic status, social risk, ethnicity, language proficiency, and educational level, as well as the geographical distance to the hospital and the gender of both the patient and the primary caregiver-act as moderators of the intervention effect. The objective is to determine if the coordinated circuit effectively mitigates traditional barriers to care and provides equitable benefits regardless of the patient's or caregiver's sociodemographic profile, among other factors.

The design of this protocol was developed with active input from a patient focus group and the collaboration of the 'AIRE' association to ensure the outcomes reflect the real-world needs of the ILD community.