OPTIMIZE-ILD-1: A Randomized, Pragmatic, Parallel-Group Trial Evaluating the Impact of an Optimized Diagnostic Circuit on Time to Diagnosis in Patients With Suspected Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Time to Diagnostic Communication
研究概览
简要总结
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.
详细描述
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 into three groups: 1) Primary Care referral without a pre-existing autoimmune disease; 2) Specialized Care referral without a pre-existing autoimmune disease; 3) referral with a pre-existing autoimmune disease, from any source. 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 Social-Familial Evaluation Scale (TSO version) 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Referral for suspected or undiagnosed interstitial lung disease (ILD).
- •At least one of the following:
- •A finding suggestive of ILD (such as reticulation, ground-glass opacities, traction bronchiectasis or honeycombing) not attributable to another disease, on a CT available at referral that includes the lung parenchyma, regardless of its indication; or
- •Persistent or progressive shortness of breath or chronic cough not attributable to another disease, accompanied by at least one of the following: an interstitial or reticular pattern on chest radiograph; reduced forced vital capacity; persistent bibasilar crackles or digital clubbing; a relevant environmental or occupational exposure, autoimmune disease, or suspected drug or radiation toxicity; or a first-degree family history of ILD.
- •Ability to provide informed consent.
排除标准
- •Complete ILD diagnostic work-up already performed (chest CT plus full pulmonary function testing including six-minute walk test plus complete ILD laboratory panel).
- •Established diagnosis of ILD previously assigned by another center or specialist.
- •Clinical instability or acute illness that would prevent reliable completion of diagnostic procedures (e.g., respiratory infection, suspected acute ILD exacerbation, acute heart failure).
- •Acute iatrogenic pneumonitis (drug-, chemotherapy- or radiation-induced) with a clear temporal relationship to the offending agent.
- •Medical, functional, psychiatric or logistical limitations that, in the investigators' opinion, would interfere with the diagnostic process or data collection.
- •Participation in another interventional clinical trial that may alter the frequency or timing of diagnostic procedures.
- •Cognitive impairment that prevents informed consent or completion of study questionnaires.
- •Refusal to participate or to allow the collection or use of clinical data.
研究组 & 干预措施
Standard ILD Diagnostic Pathway
Participants in this arm will follow the standard ILD diagnostic pathway. After referral for suspected ILD and confirmation of eligibility, 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, rheumatology or internal medicine assessment, or lung biopsy when indicated, are requested through usual clinical channels. These tests typically occur on different days. The final ILD diagnosis is assigned once all required results are available and reviewed in the ILD unit or in a multidisciplinary discussion when appropriate. The study team does not modify scheduling priorities, clinical decisions or the type of tests performed.
干预措施: Standard ILD Diagnostic Pathway (Other)
Optimized ILD Diagnostic Circuit
Participants in this arm will follow a coordinated ILD diagnostic circuit in which the same core diagnostic procedures-high-resolution chest computed tomography, complete pulmonary function tests with spirometry and diffusing capacity, six-minute walk test and a comprehensive ILD laboratory panel-are pre-bundled and scheduled within a compressed and coordinated timeframe, in as few hospital visits as possible. When clinically indicated, additional evaluations such as bronchoscopy or rheumatology/internal medicine consultation are integrated into the same coordinated workflow. All available diagnostic information is reviewed in a single multidisciplinary discussion to assign the final ILD diagnosis and initial therapeutic plan. The intervention does not introduce new diagnostic tests, alter clinical content or modify prioritization rules; it reorganizes the timing and coordination of existing diagnostic steps to reduce fragmentation and diagnostic delays.
干预措施: Optimized ILD Diagnostic Circuit (Other)
结局指标
主要结局
Time to Diagnostic Communication
时间窗: From randomization until the date of diagnostic communication to the patient (up to 18 months).
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.
次要结局
- Time to Multidisciplinary Team (MDT) Diagnosis(From randomization until the date of the MDT diagnostic consensus (up to 18 months).)
- Time to Treatment Initiation(From randomization until treatment initiation, if required (up to 18 months).)
- Diagnostic Time Burden(From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).)
- Patient and Caregiver Socioeconomic Cost-Burden(From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).)
- Hospital Direct and Operational Costs(From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).)
- Carbon Footprint of the ILD Diagnostic Pathway(From randomization until the ILD diagnosis or treatment initiation, if required (up to 18 months).)
- EQ-5D-5L Health-Related Quality of Life Questionnaire(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(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)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Clinical Frailty Scale (CFS)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Gijon Socio-familial Evaluation Scale (TSo)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Oslo-3 Social Support Scale(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Patient-Reported Experience Measures (PREMs) - Patient(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Patient-Reported Experience Measures (PREMs) - Caregiver(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Caregiver Burden Inventory - Shortened Version (CBI-15)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Interdisciplinary Professional Experience (Professional-PREMs)(At the end of the study, up to 18 months after first inclusion)
- Patient Global Impression of Change (PGIC) - Patient(At the diagnostic communication visit (up to 18 months))
- Patient Global Impression of Change (PGIC) - Caregiver(At the diagnostic communication visit (up to 18 months))
- Patient Global Impression of Change (PGIC) - Professional(At the end of the study, up to 18 months after first inclusion)
- Social Work Screening and Referral(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Sociodemographic Determinants of Equity and Access(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
- Social-Familial Evaluation Scale (TSO version)(Baseline (at the first in-person visit) and at the diagnostic communication visit (up to 18 months))
研究者
Jaume Bordas-Martinez
Principal Investigator
Hospital de Granollers