The OPTIMIZE-ILD-1 trial is a prospective, randomized, open-label clinical trial designed to evaluate the impact of a coordinated diagnostic pathway on patients with suspected interstitial lung disease (ILD). In routine clinical practice, diagnostic workflows for ILD are frequently fragmented, involving multiple independent appointments that can lead to significant delays and increased burden for patients and caregivers. This study compares the standard diagnostic pathway against an optimized circuit where core diagnostic procedures-such as high-resolution CT, pulmonary function tests, and laboratory panels-are pre-bundled and scheduled within a coordinated and compressed timeframe. All eligible patients referred for suspected ILD are included consecutively to ensure a pragmatic, real-world representation of the referral population. The primary objective is to measure the time to diagnostic communication, defined as the duration from randomization to the date the patient is formally informed of the final diagnosis following a multidisciplinary team (MDT) consensus. Secondary objectives include assessing the time to MDT diagnosis, the time to treatment initiation (when clinically indicated), socioeconomic cost-burden, and the environmental carbon footprint of the diagnostic journey. Furthermore, the study evaluates health-related quality of life, psychological distress, and clinical frailty, while exploring factors such as language proficiency as determinants of diagnostic equity. 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 the diagnostic journey's efficiency and human impact.
The primary endpoint of this study is the time to diagnostic communication, defined as the interval from randomization to the date when the final diagnosis is formally communicated to the patient following multidisciplinary team (MDT) consensus. Interstitial lung diseases (ILD) require a complex, multidimensional evaluation involving radiology, pulmonary function testing, and clinical assessment; however, fragmented scheduling in routine care often delays diagnosis and exacerbates inequities. OPTIMIZE-ILD-1 is a single-center, prospective, randomized trial with 1:1 allocation. To ensure a balanced representation of clinical entry routes and phenotypes, randomization is stratified 1:1:1 into three distinct groups: 1) referrals from Primary Care, 2) referrals from Specialized Care without a pre-existing autoimmune disease, and 3) referrals from Specialized Care with a pre-existing autoimmune disease. The intervention streamlines the coordination of existing diagnostic steps-including high-resolution chest CT, complete pulmonary function tests, and comprehensive laboratory panels-by clustering them into a coordinated workflow designed to be completed in the minimum number of hospital visits possible, without modifying clinical content or prioritization rules. Secondary outcomes evaluate the pathway's efficiency and economic impact, including time to MDT diagnosis, time to treatment initiation (where clinically indicated), and the socioeconomic cost-burden for the family unit, which accounts for direct logistical expenses, productivity loss, and hospital operational inefficiencies. Additionally, the environmental impact is quantified via the diagnostic 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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
92
Organizational usual-care comparator following the standard ILD diagnostic workflow. After referral for suspected ILD, core diagnostic procedures such as high-resolution chest computed tomography, complete pulmonary function tests (spirometry and diffusing capacity), six-minute walk test, and a comprehensive ILD laboratory panel are ordered and scheduled independently according to routine departmental workflows and waiting times. Additional procedures, including bronchoscopy with bronchoalveolar lavage or rheumatology/internal medicine assessment, are requested when clinically indicated. These diagnostic tests and visits usually occur on separate days, and the final diagnosis is assigned once all required results are available and reviewed in the ILD unit or in a multidisciplinary discussion. The intervention does not modify clinical content, scheduling priorities, or the type of tests performed.
Organizational intervention that coordinates and bundles core ILD diagnostic procedures into a compressed and structured workflow. For patients with suspected ILD, high-resolution chest computed tomography, complete pulmonary function tests (spirometry and diffusing capacity), the six-minute walk test, and a comprehensive ILD laboratory panel are pre-bundled and scheduled within a shortened timeframe, ideally within one or two coordinated visits. When required, bronchoscopy and rheumatology/internal medicine assessments are integrated into the same coordinated pathway. All available diagnostic results are reviewed in a single multidisciplinary discussion to assign the final ILD diagnosis and the initial therapeutic plan. The intervention does not introduce new tests or alter clinical decision-making; it reorganizes the timing and coordination of existing procedures without modifying waiting-list rules.
Hospital General de Granollers
Granollers, Barcelona, Spain
RECRUITINGTime to Diagnostic Communication
Time (measured in days) elapsed from the date of randomization to the date when the final diagnosis is formally communicated to the patient. This measure captures the complete diagnostic process, including the scheduling and performance of all tests (imaging, PFTs, labs), the Multidisciplinary Team (MDT) consensus meeting, and the subsequent clinical appointment where the patient is informed of the findings and the initial management plan.
Time frame: From randomization until the date of diagnostic communication to the patient (up to 18 months).
Time to Multidisciplinary Team (MDT) Diagnosis
Time elapsed from the randomization to the date of the multidisciplinary team (MDT) meeting where a final diagnostic consensus is reached. This measure evaluates the internal efficiency of the clinical work-up and the diagnostic decision-making process prior to patient communication.
Time frame: From randomization until the date of the MDT diagnostic consensus (up to 18 months).
Time to Treatment Initiation
Time elapsed from the randomization to the date of initiation of the first pharmacological or non-pharmacological treatment. This measure will be calculated only for participants for whom treatment is clinically indicated according to the multidisciplinary team (MDT) consensus.
Time frame: From randomization until treatment initiation, if required (up to 18 months).
Diagnostic Time Burden
Total time required for the patient and caregivers to complete the diagnostic work-up (Home-to-Home), including the cumulative time spent travelling from home to the hospital and back for all diagnostic visits, as well as the cumulative in-hospital time needed to complete scheduled tests, evaluations and procedures.
Time frame: From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).
Patient and Caregiver Socioeconomic Cost-Burden
This outcome assesses the private economic impact and "Financial Toxicity" on the family unit. It evaluates: 1. Direct Non-Medical Costs: Private expenses related to transportation, parking, and logistics required for hospital attendance. 2. Indirect Costs (Productivity Loss): Economic value of the time dedicated to the diagnostic process by both the patient and the primary caregiver, including work absenteeism and disruption of daily obligations. 3. 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 diagnostic circuit.
Time frame: From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).
Hospital Direct and Operational Costs
This measure calculates the total economic impact on the healthcare system during the diagnostic pathway. It includes: 1. Direct Clinical Costs: Outpatient visits, multidisciplinary committee reviews, and diagnostic tests (CT scans, lung function tests, and biopsies) based on standard hospital billing rates. 2. Operational Costs: Administrative staff time dedicated to the coordination and scheduling of the circuit. 3. Inefficiency Costs: Opportunity costs derived from non-attended appointments (no-shows), missed or incomplete diagnostic procedures requiring rescheduling, and unscheduled emergency visits. All values are calculated in Euros (€). Higher scores indicate higher healthcare resource utilization and lower operational efficiency
Time frame: From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).
Carbon Footprint of the ILD Diagnostic Pathway
Estimated carbon dioxide equivalent emissions (CO₂-Equivalent Emissions) generated by patient and caregiver travel and healthcare resource use during the diagnostic process.
Time frame: From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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).
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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 diagnostic 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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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 diagnostic 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.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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). Total score ranges from 0 to 60. A total score \>=25 has been identified as a cut-off point to discriminate caregivers with probable mental disorder (sensitivity 70.6%, specificity 70.7%). The multidimensional structure allows identification of the specific type of burden most affected by the intervention. Spanish version validated by Vazquez et al. (Int J Environ Res Public Health 2019;16:217). Assessed only for participants with a primary caregiver who provides independent informed consent.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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 diagnostic 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.
Time frame: At the end of the study, up to 18 months after first 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 diagnostic process 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 diagnostic pathway organization.
Time frame: At the diagnostic communication visit (up to 18 months)
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 diagnostic process 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.
Time frame: At the diagnostic communication visit (up to 18 months)
Patient Global Impression of Change (PGIC) - Professional
A single-item measure in which each healthcare professional involved in the ILD diagnostic 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.
Time frame: 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 (time to diagnostic communication) 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 the diagnostic pathway regardless of the patient's sociodemographic profile.
Time frame: Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months)
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