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

NCT07486206 | Recruiting

• 1 other identifier: OPTIMIZE-ILD-2-HGG
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Interstitial Lung Disease; ILD; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Progressive Pulmonary Fibrosis; CTD-ILD; Fibrotic ILD; Antifibrotic Therapy; Immunosuppressive Therapy; Follow-Up Pathway; Follow-Up Care Coordination; Time Burden; Home-to-Home Time Burden; One-Day ILD Clinic; Health Services Research; Patient-Centered Follow-Up; Organizational Intervention; Pulmonary Function Tests; Quality of Life; Patient Experience; Carbon Footprint; Multidisciplinary Care

Outcome Measures

Primary Outcomes (1)

• Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time)

  Total time spent by the participant to complete the ILD follow-up cycle, defined as the sum of: (a) home-to-hospital and hospital-to-home travel time required for the follow-up visit, and (b) in-hospital time required to complete all scheduled tests, consultations and procedures. Time will be recorded in hours using a structured case report form and a standardized patient interview. Each participant will undergo one comprehensive follow-up assessment within the predefined follow-up cycle.

  Through study completion, an average of 6 months after inclusion.

Secondary Outcomes (19)

• Patient and Caregiver Socioeconomic Cost-Burden

  Through study completion, an average of 6 months after inclusion.

• Hospital Direct and Operational Costs

  Through study completion, an average of 6 months after inclusion.

• Carbon Footprint of the ILD Follow-Up Pathway

  Through study completion, an average of 6 months after inclusion.

• EQ-5D-5L Health-Related Quality of Life Questionnaire

  Through study completion, an average of 6 months after inclusion.

• King's Brief Interstitial Lung Disease (K-BILD) Questionnaire

  Through study completion, an average of 6 months after inclusion.

Study Arms (2)

Standard ILD Follow-Up Pathway

ACTIVE COMPARATOR

Participants in this arm will follow the standard ILD follow-up pathway, in which routine components of ILD monitoring-such as pulmonary function tests, six-minute walk test when performed, laboratory analyses, imaging when clinically indicated, pharmacy consultations, nursing assessments and medical visits-are scheduled independently by each department according to routine workflows and availability. These procedures usually take place on separate days, and completing a full follow-up cycle commonly requires multiple hospital visits. The organizational structure of care, scheduling processes and clinical content remain unchanged.

Other: Standard ILD Follow-Up Pathway

Optimized One-Day ILD Follow-Up Circuit

EXPERIMENTAL

Participants in this arm will follow an optimized coordinated ILD follow-up circuit in which all required procedures are pre-scheduled and consolidated into a single structured one-day visit. This includes medical consultation, nursing assessment, pharmacy review, pulmonary function testing, laboratory analyses and imaging when clinically indicated. When needed, rheumatology or internal medicine evaluation is incorporated into the same coordinated visit. The intervention does not introduce new tests, does not modify clinical decision-making and does not alter hospital prioritization or waiting-list rules; it reorganizes the timing and coordination of existing procedures to reduce fragmentation and overall time burden.

Other: Optimized One-Day ILD Follow-Up Circuit

Interventions

Standard ILD Follow-Up Pathway OTHER

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.

Standard ILD Follow-Up Pathway

Optimized One-Day ILD Follow-Up Circuit OTHER

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.

Optimized One-Day ILD Follow-Up Circuit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Established diagnosis of interstitial lung disease (ILD).
• Currently receiving antifibrotic therapy, immunosuppressive therapy, or both, as part of routine ILD care.
• Under active follow-up at the participating ILD center.
• Able to attend the required follow-up procedures included in the study visit.
• Able to provide informed consent.

You may not qualify if:

• Inability to complete the coordinated follow-up visit for non-medical reasons (e.g., logistical impossibility).
• Clinical instability or acute illness interfering with planned follow-up procedures (such as respiratory infection, suspected ILD exacerbation, acute heart failure, or other acute conditions).
• Participation in another interventional clinical trial that may alter visit frequency or follow-up structure.
• Cognitive impairment preventing informed consent or completion of questionnaires.
• Patient refusal to participate or refusal to allow data collection.

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaume Bordas-Martinez, MD, PhD

  Hospital General de Granollers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, consecutive, randomized, open-label, parallel-group clinical trial evaluating whether an optimized coordinated follow-up circuit reduces total time burden compared with the standard ILD follow-up pathway. A total of 152 participants with established interstitial lung disease receiving antifibrotic and/or immunosuppressive therapy will be enrolled. Randomization is 1:1 and stratified by treatment category: antifibrotic therapy only; immunosuppressive therapy only; or combined therapy. Each participant undergoes a single comprehensive follow-up assessment within a predefined evaluation cycle.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 20, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary results and for a period of up to 5 years.
• Access Criteria: Access to IPD will be granted to researchers with a methodologically sound proposal and a clear scientific objective. Requests must be submitted to the Principal Investigator. Approval will require compliance with institutional data-protection policies, signing a data-use agreement, and ensuring secure data handling. No data containing personal identifiers will be provided.

Locations

ES (1)