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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease (ILD); Idiopathic Pulmonary Fibrosis (IPF); Fibrotic Interstitial Lung Disease; Progressive Pulmonary Fibrosis; Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
• Intervention / Treatment: Other: Standard ILD Follow-Up Pathway; Other: Optimized One-Day ILD Follow-Up Circuit

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.

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Granollers, Barcelona, Spain, 08402
      • Recruiting
      • Hospital General De Granollers
      • Contact: Jaume Bordas-Martínez, MD, PhD; Phone Number: +34 938 425 00 +34 938 425 000; Email: jbordas@fphag.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard ILD Follow-Up Pathway; 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; 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.
Experimental: Optimized One-Day ILD Follow-Up Circuit; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Caregiver Socioeconomic Cost-Burden	This outcome assesses the private economic impact and "Financial Toxicity" on the family unit. It evaluates: Direct Non-Medical Costs: Private expenses related to transportation, parking, and logistics required for hospital attendance.; Indirect Costs (Productivity Loss): Economic value of the time dedicated to the monitoring process by both the patient and the primary caregiver, including work absenteeism and disruption of daily obligations.; Caregiver Burden: Impact on the support network, analyzed to identify potential gender gaps in caregiving. Data is expressed in Euros (€). Higher values indicate a greater socioeconomic burden and higher "Time Burden" imposed by the follow-up circuit.	Through study completion, an average of 6 months after inclusion.
Hospital Direct and Operational Costs	This measure calculates the total economic impact on the healthcare system during the follow-up pathway. It includes: Direct Clinical Costs: Outpatient visits, multidisciplinary committee reviews, and monitoring tests (CT scans, lung function tests, and biopsies) based on standard hospital billing rates.; Operational Costs: Administrative staff time dedicated to the coordination and scheduling of the circuit.; Inefficiency Costs: Opportunity costs derived from non-attended appointments (no-shows), missed or incomplete follow-up procedures requiring rescheduling, and unscheduled emergency visits. All values are calculated in Euros (€). Higher scores indicate higher healthcare resource utilization and lower operational efficiency	Through study completion, an average of 6 months after inclusion.
Carbon Footprint of the ILD Follow-Up Pathway	Estimated CO₂-equivalent emissions generated by patient and caregiver travel and healthcare resource use during the follow-up cycle. Emissions are calculated from reported travel distance, transport mode and number of companions using validated emission factors.	Through study completion, an average of 6 months after inclusion.
EQ-5D-5L Health-Related Quality of Life Questionnaire	The EQ-5D-5L is a standardized instrument for measuring generic health status. It consists of a descriptive system covering 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the EQ Visual Analogue Scale (EQ-VAS). The 5 dimensions are scored on 5 levels (1=no problems to 5=extreme problems). The EQ-VAS records the patient's self-rated health on a scale from 0 (worst health) to 100 (best health). Results are reported as an index score (ranging from <0 to 1, where 1 is perfect health) and the VAS score. Higher scores in the index and VAS indicate better quality of life.	Through study completion, an average of 6 months after inclusion.
King's Brief Interstitial Lung Disease (K-BILD) Questionnaire	The K-BILD is a validated 15-item health-related quality of life questionnaire specifically designed for patients with interstitial lung disease (ILD). It assesses three domains: psychological, breathlessness and activities, and chest symptoms. Each item is scored on a 7-point Likert scale. A total score and three domain scores are calculated. Scores are transformed to a range of 0 to 100, where 100 represents the best health status and 0 the worst. A higher score reflects a better quality of life related to the respiratory disease.	Through study completion, an average of 6 months after inclusion.
Clinical Frailty Scale (CFS)	The CFS is a 9-point scale used to assess the overall level of fitness or frailty in older adults or patients with chronic conditions. It is based on clinical judgment of the patient's mobility, activity, and independence in daily living. The scale ranges from 1 (Very Fit) to 9 (Terminally Ill). A score of ≥5 is generally considered to represent frailty. Higher scores indicate a higher degree of clinical frailty.	Through study completion, an average of 6 months after inclusion.
Gijon Socio-familial Evaluation Scale (TSo)	A scale used to detect social risk or social isolation. It evaluates 5 domains: family situation, economic status, housing, social relationships, and social support. Each item is scored 1 to 5. The total score ranges from 5 to 25. Higher scores reflect greater social vulnerability (10-14: social risk; ≥15: social problem).	Through study completion, an average of 6 months after inclusion.
Patient-Reported Experience Measures (PREMs) - Patient	The PREM-Patient is a study-specific, self-administered 11-item questionnaire developed by the investigators to assess the patient's healthcare experience in the ILD follow-up pathway. As an ad hoc instrument, it evaluates 11 quality domains: 1) Clarity, 2) Coordination, 3) Accessibility (staff contact), 4) Logistical Efficiency, 5) Process Agility, 6) Prioritization (accompained visits), 7) Economic Impact, 8) Life Balance, 9) Information Redundancy, 10) Safety, and 11) Clinical Support. Each item is scored on a Likert scale from 0 (Completely Disagree) to 10 (Completely Agree). The total score is the sum of the 11 items (score ranges from 0 to 110), where higher scores indicate a more optimized and patient-centered experience. A 12th item assesses Global Satisfaction separately.	Through study completion, an average of 6 months after inclusion.
Patient-Reported Experience Measures (PREMs) - Caregiver	The PREM-Caregiver is a study-specific, self-administered 11-item questionnaire developed by the investigators to assess the healthcare experience of the caregiver in the ILD follow-up pathway. This ad hoc instrument evaluates 11 quality domains: 1) Clarity, 2) Coordination, 3) Accessibility (staff contact), 4) Logistical Efficiency, 5) Process Agility, 6) Prioritization (accompained visits), 7) Economic Impact, 8) Life Balance, 9) Information Redundancy, 10) Safety, and 11) Clinical Support. Each item is scored on a Likert scale from 0 to 10. The total score ranges from 0 to 110, where higher scores indicate a more optimized experience and lower treatment burden for the family unit. A 12th item assesses Global Satisfaction separately. Assessed only for participants with a primary caregiver who provides independent informed consent for this specific evaluation.	Through study completion, an average of 6 months after inclusion.
Interdisciplinary Professional Experience (Professional-PREMs)	The PREM-Clinician is a study-specific, self-administered 11-item questionnaire developed by the investigators to assess the professional experience of all staff involved in the ILD follow-up pathway, including clinicians and other involved healthcare professionals (including nursing, pharmacy, and social work). As an ad hoc instrument, it evaluates 11 quality domains: 1) Inter-professional Coordination, 2) Administrative Burden, 3) Protocol Clarity, 4) Process Agility, 5) Information Provided to Patient, 6) Caregiver Integration, 7) Operational Sustainability, 8) Resource Efficiency, 9) Perceived Patient/Family Satisfaction, 10) Clinical Safety, and 11) Multidisciplinary Support. Each item is scored on a Likert scale (0-10). Total score: 0 to 110. Higher scores indicate a more optimized and collaborative workflow. A 12th item assesses Global Satisfaction separately.	At the end of the study, up to 18 months after first inclusion
Generalized Anxiety Disorder 7-item Scale (GAD-7)	The GAD-7 is a validated 7-item self-report questionnaire used to screen for and measure the severity of generalized anxiety. Each item is scored on a 4-point Likert scale (0=Not at all to 3=Nearly every day). The total score ranges from 0 to 21. Established severity thresholds are: 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety. Higher scores indicate greater anxiety severity.	Through study completion, an average of 6 months after inclusion.
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 is a validated 9-item self-report questionnaire used to screen for and measure the severity of depression. Each item is scored on a 4-point Likert scale (0=Not at all to 3=Nearly every day). The total score ranges from 0 to 27. Established severity thresholds are: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A score of >=10 is commonly used as the threshold for clinically significant depression. Higher scores indicate greater depressive symptom severity.	Through study completion, an average of 6 months after inclusion.
Oslo-3 Social Support Scale	The Oslo-3 is a brief 3-item instrument that assesses the level of perceived social support. It evaluates the number of close confidants, the sense of concern from others, and the ease of obtaining practical help from neighbors. The total score ranges from 3 to 14 and is categorized as: 3-8 poor support, 9-11 moderate support, and 12-14 strong support. Higher scores indicate greater perceived social support.	Through study completion, an average of 6 months after inclusion.
Social Work Screening and Referral	A study-specific 7-item screening questionnaire, developed in collaboration with the Hospital Social Work Department, designed to identify patients who may benefit from social work assessment. The instrument evaluates: 1) Prior contact with social services (informative), 2) Awareness of available public resources for disability or chronic disease, 3) Digital literacy barriers affecting appointment management, 4) Need for home support or difficulty leaving the home, 5) Disability or dependency recognition status, 6) Perceived caregiver overburden, and 7) Patient willingness to receive social work consultation. Referral to social work is offered when any item triggers a positive response, or when the Gijon Scale indicates social risk (>=12), the Oslo-3 indicates poor social support (<=8), or the CBI-15 indicates high caregiver burden (>=25). The proportion of patients meeting referral criteria, the effective referral rate, and the specific unmet needs identified will be reported.	Through study completion, an average of 6 months after inclusion.
Caregiver Burden Inventory - Shortened Version (CBI-15)	The CBI-15 is a validated 15-item multidimensional questionnaire that assesses caregiver burden across five domains: time-dependence burden (3 items), personal life burden (3 items), physical burden (3 items), social burden (3 items), and emotional burden (3 items). Each item is scored on a 5-point Likert scale (0=Not at all disruptive to 4=Very disruptive). The total score ranges from 0 to 60. A total score of >=25 has been identified as a cut-off point to discriminate caregivers with probable mental disorder (sensitivity 70.6%, specificity 70.7%). Higher scores indicate greater perceived burden. The Spanish version validated by Vazquez et al. (Int J Environ Res Public Health 2019;16:217) is used. Assessed only for participants with a primary caregiver who provides independent informed consent for this specific evaluation.	Through study completion, an average of 6 months after inclusion.
Patient Global Impression of Change (PGIC) - Patient	A single-item measure in which the patient rates their overall impression of how the organization of the follow-up visit compared to their expectations, using a 7-point Likert scale (1=Much better than expected to 7=Much worse than expected). This measure serves as an anchor to determine the minimal clinically important difference (MCID) of the study-specific PREMs. Lower scores indicate a more favorable impression of the follow-up pathway organization.	Through study completion, an average of 6 months after inclusion.
Patient Global Impression of Change (PGIC) - Caregiver	A single-item measure in which the primary caregiver rates their overall impression of how the organization of their family member's follow-up visit compared to their expectations, using a 7-point Likert scale (1=Much better than expected to 7=Much worse than expected). Lower scores indicate a more favorable impression. Assessed only for participants with a primary caregiver who provides independent informed consent.	Through study completion, an average of 6 months after inclusion.
Patient Global Impression of Change (PGIC) - Professional	A single-item measure in which each healthcare professional involved in the ILD follow-up pathway rates their overall impression of the pathway's organizational quality compared to their prior expectations, using a 7-point Likert scale (1=Much better than expected to 7=Much worse than expected). Lower scores indicate a more favorable professional impression of the coordinated circuit.	At the end of the study, up to 18 months after first inclusion
Sociodemographic Determinants of Equity and Access	Pre-planned exploratory analysis measuring the variation in the primary outcome (total follow-up time burden) and key secondary outcomes stratified by sociodemographic determinants -- including socioeconomic status (Gijon Socio-familial Evaluation Scale), perceived social support (Oslo-3 Social Support Scale), unmet social needs (Social Work Screening Questionnaire), ethnicity, gender of both the patient and the primary caregiver, language proficiency, educational level, and geographical distance to the hospital. This analysis evaluates the magnitude of potential disparities and the intervention's capacity to ensure equitable access to follow-up care regardless of the patient's sociodemographic profile.	Through study completion, an average of 6 months after inclusion.

Collaborators and Investigators

• Sponsor: Hospital de Granollers
• Investigators: Principal Investigator: Jaume Bordas-Martinez, MD, PhD, Hospital General De Granollers

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Health Services Research; Carbon Footprint; ILD; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Interstitial Lung Disease; Immunosuppressive Therapy; Patient Experience; Pulmonary Function Tests; CTD-ILD; Multidisciplinary Care; Progressive Pulmonary Fibrosis; One-Day ILD Clinic; Organizational Intervention; Fibrotic ILD; Antifibrotic Therapy; Follow-Up Pathway; Follow-Up Care Coordination; Time Burden; Home-to-Home Time Burden; Patient-Centered Follow-Up
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial
• Other Study ID Numbers: OPTIMIZE-ILD-2-HGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual participant data (IPD) underlying the primary and secondary outcome results will be made available to qualified researchers upon reasonable request after publication of the main study results. Shared data will include variables required to reproduce the main analyses, excluding any information that could directly identify participants. No imaging files or raw free-text data will be shared.
• IPD Sharing Time Frame: Beginning 12 months after publication of the primary results and for a period of up to 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No