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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time)
研究概览
简要总结
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.
详细描述
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.
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.
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Standard ILD Follow-Up Pathway (Other)
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.
干预措施: Optimized One-Day ILD Follow-Up Circuit (Other)
结局指标
主要结局
Total Follow-Up Time Burden (Home-to-Home and In-Hospital Time)
时间窗: Through study completion, an average of 6 months after inclusion.
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.
次要结局
- Sociodemographic Determinants of Equity and Access(Through study completion, an average of 6 months after inclusion.)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Through study completion, an average of 6 months after inclusion.)
- Patient Health Questionnaire-9 (PHQ-9)(Through study completion, an average of 6 months after inclusion.)
- Oslo-3 Social Support Scale(Through study completion, an average of 6 months after inclusion.)
- Social Work Screening and Referral(Through study completion, an average of 6 months after inclusion.)
- Caregiver Burden Inventory - Shortened Version (CBI-15)(Through study completion, an average of 6 months after inclusion.)
- Patient Global Impression of Change (PGIC) - Patient(Through study completion, an average of 6 months after inclusion.)
- Patient Global Impression of Change (PGIC) - Caregiver(Through study completion, an average of 6 months after inclusion.)
- Patient Global Impression of Change (PGIC) - Professional(At the end of the study, up to 18 months after first inclusion)
- 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.)
- Living with Pulmonary Fibrosis (L-PF) Questionnaire(Through study completion, an average of 6 months after inclusion.)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 6 months after inclusion.)
- Clinical Frailty Scale (CFS)(Through study completion, an average of 6 months after inclusion.)
- Gijon Socio-familial Evaluation Scale (TSo)(Through study completion, an average of 6 months after inclusion.)
- Patient-Reported Experience Measures (PREMs) - Patient(Through study completion, an average of 6 months after inclusion.)
- Patient-Reported Experience Measures (PREMs) - Caregiver(Through study completion, an average of 6 months after inclusion.)
- Zarit Burden Interview (ZBI-12) - Short Version(Through study completion, an average of 6 months after inclusion.)
- Interdisciplinary Professional Experience (Professional-PREMs)(At the end of the study, up to 18 months after first inclusion)
研究者
Jaume Bordas-Martinez
Principal Investigator
Hospital de Granollers