Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial

The primary endpoint of this study is the total follow-up time burden, defined as the home-to-home time interval (from the moment the patient departs from their residence until their return) required to complete the scheduled monitoring circuit. Established interstitial lung diseases (ILD) require periodic, multidimensional monitoring; however, fragmented scheduling often necessitates multiple hospital visits and independent appointments, exacerbating patient fatigue and logistical inequities. OPTIMIZE-ILD-2 is a single-center, prospective, randomized trial with 1:1 allocation.

To ensure a balanced representation of monitoring complexity, randomization is stratified 1:1:1 based on the patient's pharmacological regimen: 1) patients receiving antifibrotic therapy, 2) patients receiving immunosuppressive therapy, and 3) patients receiving a combination of both antifibrotic and immunosuppressive therapies. The intervention streamlines the coordination of existing follow-up steps-including pulmonary function tests, laboratory panels, imaging studies, treatment administration, and consultations-by clustering them into a coordinated workflow designed to be completed in the minimum number of hospital visits possible, without modifying clinical content. This cross-sectional intervention evaluates the impact of the pathway at a specific follow-up node.

Secondary outcomes evaluate the pathway's efficiency and economic impact, including hospital operational resource utilization and the socioeconomic cost-burden for the family unit, which accounts for direct logistical expenses and productivity loss. Additionally, the environmental impact is quantified via the 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.

• Patient and Caregiver Socioeconomic Cost-Burden [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Hospital Direct and Operational Costs [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Carbon Footprint of the ILD Follow-Up Pathway [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• EQ-5D-5L Health-Related Quality of Life Questionnaire [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• King's Brief Interstitial Lung Disease (K-BILD) Questionnaire [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Generalized Anxiety Disorder 7-item Scale (GAD-7) [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Clinical Frailty Scale (CFS) [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Gijon Socio-familial Evaluation Scale (TSo) [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Oslo-3 Social Support Scale [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Social Work Screening and Referral [Срок оценки: Through study completion, an average of 6 months after inclusion.]
• Patient-Reported Experience Measures (PREMs) - Patient [Срок оценки: Through study completion, an average of 6 months after inclusion.]