Optimizing the Follow-Up Journey in Interstitial Lung Disease: The OPTIMIZE-ILD-2 Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard ILD Follow-Up Pathway, Optimized One-Day ILD Follow-Up Circuit.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease (ILD), Fibrotic Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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 proc - 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 in
Primary outcome measures
- Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time) [Time frame: Through study completion, an average of 6 months after inclusion.]
Secondary outcome measures (12)
- Patient and Caregiver Socioeconomic Cost-Burden [Time frame: Through study completion, an average of 6 months after inclusion.]
- Hospital Direct and Operational Costs [Time frame: Through study completion, an average of 6 months after inclusion.]
- Carbon Footprint of the ILD Follow-Up Pathway [Time frame: Through study completion, an average of 6 months after inclusion.]
- EQ-5D-5L Health-Related Quality of Life Questionnaire [Time frame: Through study completion, an average of 6 months after inclusion.]
- King's Brief Interstitial Lung Disease (K-BILD) Questionnaire [Time frame: Through study completion, an average of 6 months after inclusion.]
- Generalized Anxiety Disorder 7-item Scale (GAD-7) [Time frame: Through study completion, an average of 6 months after inclusion.]
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: Through study completion, an average of 6 months after inclusion.]
- Clinical Frailty Scale (CFS) [Time frame: Through study completion, an average of 6 months after inclusion.]
- Gijon Socio-familial Evaluation Scale (TSo) [Time frame: Through study completion, an average of 6 months after inclusion.]
- Oslo-3 Social Support Scale [Time frame: Through study completion, an average of 6 months after inclusion.]
- Social Work Screening and Referral [Time frame: Through study completion, an average of 6 months after inclusion.]
- Patient-Reported Experience Measures (PREMs) - Patient [Time frame: Through study completion, an average of 6 months after inclusion.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Spain · 1 center
- Hospital General de Granollers — Granollers
Identifiers
NCT: NCT07486206 · OPTIMIZE-ILD-2-HGG