UDOPAL Study: Hospital-at-Home Interventional Approach to Pain Management in Patients Receiving Home-Based Hospital Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)
研究概览
简要总结
The UDOPAL Study proposes an innovative home-based care approach for the management of pain in patients admitted to the Home Hospitalization Unit (UHD). This model incorporates interventional pain management techniques into the clinical practice of home-hospital professionals, supported when necessary by specialists from the Pain Medicine Unit.
Pain is a prevalent and often undertreated problem in patients receiving home hospitalization, where complex or oncologic pain may require specialized procedures that traditionally are only performed in hospital settings. The UDOPAL model aims to bridge this gap by providing ultrasound-guided and minimally invasive pain procedures directly at the patient's home, including nerve blocks, infiltrations, and other targeted interventions.
This observational, prospective study evaluates the feasibility, safety, and clinical impact of implementing interventional pain management at home. Adult patients with chronic, oncologic, or complex pain will be included. Outcomes include pain intensity, opioid use, functional improvement, quality of life, and patient satisfaction, as well as adverse events related to the techniques.
The study seeks to provide scientific evidence supporting a new model of interventional home-based pain care that improves comfort, continuity of care, and efficient use of healthcare resources. The project was approved by the Ethics Committee (CEIm Hospital Universitario y Politécnico La Fe, Acta No. 600, 08/10/2025) and is conducted at Hospital de Manises (Valencia, Spain).
详细描述
Introduction
Pain is one of the most prevalent and distressing symptoms among patients receiving home hospitalization, especially those with chronic or oncologic conditions. Despite the advances in home-based medicine, the management of moderate to severe pain continues to be a clinical challenge. Conventional pharmacological treatment alone is often insufficient, and access to specialized interventional pain techniques remains limited to hospital settings.
In traditional care models, patients experiencing uncontrolled pain must be transferred to the hospital for evaluation or intervention, leading to fragmentation of care, increased healthcare costs, and a significant emotional burden for patients and families. These transfers often disrupt the continuity of palliative and supportive care that the home-hospitalization environment seeks to provide.
The UDOPAL Study (from Unidad del Dolor + Hospitalización Domiciliaria) was designed to address this gap by introducing a structured, collaborative model that enables interventional pain management to be performed safely and effectively at home. This initiative positions home-hospital professionals at the center of the intervention, empowering them to deliver advanced pain procedures within the patient's own environment, supported by the Pain Medicine Unit when required.
The study reflects an evolution in the concept of pain management-shifting from a hospital-centered model to an integrated, patient-centered continuum of care. The UDOPAL model aligns with the principles of the World Health Organization and modern palliative medicine, emphasizing early, multidisciplinary, and accessible interventions that improve comfort, dignity, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (≥18 years old) admitted to the Home Hospitalization Unit (UHD) of the Manises Health Department.
- •Presence of active pain, classified as mild, moderate, or severe.
- •Clinical assessment indicating suitability for interventional pain management, as determined by a UDOPAL-trained physician.
- •Physical and clinical conditions that allow the performance of interventional procedures at home under standardized safety precautions.
- •Signed informed consent obtained from the patient and/or a legally authorized representative in cases of incapacity.
排除标准
- •Very limited life expectancy (estimated survival <72 hours) or terminal/agonal condition.
- •Contraindication to interventional pain procedures, including:
- •Uncorrectable coagulopathy.
- •Systemic infection or local infection at the puncture site.
- •Documented allergy to any of the planned medications.
- •Tumor located in the infiltration area.
- •Pregnancy or breastfeeding.
- •Altered level of consciousness or severe cognitive impairment without a responsible family member or without the possibility of obtaining valid informed consent.
- •Home environment conditions that do not ensure minimal hygiene, safety, or logistical support (e.g., inadequate lighting, lack of privacy, insufficient family assistance, or limited access for the medical team).
- •Explicit refusal by the patient and/or family to undergo interventional pain procedures.
- •Refusal to participate in the study.
结局指标
主要结局
Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)
时间窗: Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) for patients able to self-report pain. The primary outcome represents the mean reduction in NRS pain intensity from baseline to each follow-up point.
Change in Pain Intensity (PAINAD 0-10 for patients with cognitive impairment)
时间窗: Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)
Pain intensity will be assessed using the Pain Assessment in Advanced Dementia Scale (PAINAD, 0-10) for patients with cognitive impairment or communication difficulties. The primary outcome represents the mean reduction in PAINAD score from baseline to each follow-up point.
次要结局
- Opioid Consumption(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Functional Status(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Patient and Family Satisfaction(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Professional Perception of Feasibility(baseline and at completion of the implementation phase (approximately 1 month))
- Change in Quality of Life (EQ-5D-5L Score)(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Change in Functional Status (Barthel Index)(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Change in Analgesic Consumption Profile(Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU))
- Incidence of Adverse Events Related to Home-Based Interventional Pain Procedures(From procedure initiation until 1 month follow-up or discharge from the Home Hospitalization Unit (HHU), whichever occurs later)
- Rate of Unplanned Hospital Transfers(From procedure initiation until 1 month follow-up or discharge from the Home Hospitalization Unit , whichever occurs later)
- Number of Interconsultations Between the Home Hospitalization Unit and the Pain MedicineUnit(Throughout the entire home-hospitalization episode and during the 1-month follow-up period)
- Response Time From Indication to Procedure Completion(From clinical indication to completion of the interventional procedure (measured for each patient during the home-hospitalization episode))
- Total Consultation Time Including Procedure Duration(At each home visit in which an interventional pain procedure is performed)
- Number of Interventional Pain Procedures Performed at Home(tecniques per patient/ tecniques per month)
- Number of Patients Undergoing Interventional Pain Procedures at Home(tecniques per patient)
研究者
Estefania Romero Serrano, MD, PhD
Principal Investigator, UDOPAL Intervention Program, Pain Medicine Unit, Hospital de Manises
Hospital de Manises