NCT07486206

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

OPTIMIZE-ILD-2: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Coordinated Follow-Up Circuit on Time Burden in Patients With Interstitial Lung Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Hospital de Granollers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The OPTIMIZE-ILD-2 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated follow-up pathway on patients with established interstitial lung disease (ILD). In routine clinical practice, follow-up workflows for ILD are frequently fragmented, requiring multiple hospital visits for pulmonary function tests, laboratory analysis, treatment administration, and consultations with various specialists, which increases the burden for both patients and caregivers. This study compares the standard follow-up care against an optimized circuit where all routine monitoring procedures and interdisciplinary consultations are pre-bundled and scheduled within a single, coordinated hospital visit. All eligible patients under active ILD follow-up are included consecutively to ensure a pragmatic, real-world representation of the treated ILD population. The primary objective is to measure the total follow-up time burden, defined as the total home-to-home time required to complete the follow-up circuit. As a cross-sectional assessment within a longitudinal context, secondary objectives include assessing socioeconomic cost-burden, the environmental carbon footprint of the follow-up journey, health-related quality of life, and clinical frailty. 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 follow-up efficiency and human impact.

Detailed description

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.

Conditions

• Interstitial Lung Disease (ILD)
• Fibrotic Interstitial Lung Disease
• Idiopathic Pulmonary Fibrosis (IPF)
• Progressive Pulmonary Fibrosis
• Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)

Interventions

Type	Name	Description
OTHER	Standard ILD Follow-Up Pathway	Organizational usual-care comparator consisting of the standard ILD follow-up pathway. For patients with established ILD receiving antifibrotic and/or immunosuppressive therapy, follow-up components such as pulmonary function tests, 6-minute walk test when performed, laboratory monitoring, imaging when indicated, pharmacy visits, nursing assessments, and medical consultations are requested and scheduled independently by each department according to routine workflows and waiting times. These procedures usually occur on separate days, and a full follow-up cycle frequently requires multiple hospital visits. The study team does not alter scheduling priorities, clinical decisions, or the type of tests performed.
OTHER	Optimized One-Day ILD Follow-Up Circuit	Organizational intervention that coordinates and bundles all required ILD follow-up procedures into a single structured "one-day" visit. For patients with established ILD on antifibrotic and/or immunosuppressive therapy, the intervention pre-schedules pulmonary function tests, laboratory monitoring, imaging when indicated, pharmacy consultation, nursing assessment, and medical visits within the same day. When clinically necessary, rheumatology or internal medicine consultations are integrated into the same coordinated circuit. The intervention does not introduce new tests or treatments and does not modify hospital waiting-list rules; it only reorganizes the timing and consolidation of existing follow-up procedures to reduce overall time burden.

Timeline

• Start date: 2026-03-09
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-20
• Last updated: 2026-04-09

Locations

1 site across 1 country: Spain