Impact of Implementing Telemedicine in Home Hospitalization: e-Salut Project in Patients Admitted to the Home Hospitalization Unit of the Hospital Germans Trias i Pujol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Number of Participants With Hospital Readmission Within 30 Days After Discharge From Hospital-at-Home
研究概览
简要总结
The objective of the study is to evaluate the impact caused by the use of the e-Salut Metro Nord App on the home hospitalization care process compared to the conventional model of care.
A randomized clinical trial will be conducted with two groups: control group (patients using the conventional care model) and experimental group (patients using the app).
The study population includes patients admitted to the Home Hospitalization Unit (HAD) of the Hospital Universitari Germans Trias i Pujol who agree to participate between January 2024 and April 2025.
The independent variable is the use of the App. The dependent/outcome variables include: generated alerts, number of patient-initiated phone calls to professionals, App users who complete questionnaires, detected complications, unplanned in-person visits in HAD, unplanned phone visits in HAD, scheduled in-person nursing visits, scheduled medical visits, time elapsed between an alert and the professional's response, time for management and resolution of complications, unplanned visits generated by alerts, number of readmissions, patient/caregiver satisfaction, sex, age, functional assessment (Barthel Index), cognitive impairment assessment (Pfeiffer Test), anxiety and depression scales (HADS), patient activation measure (PAM-13), empowerment measure (CEPEC-47), therapeutic adherence test (ARMS-e), and health literacy (HLS-EU-Q16).
详细描述
Several studies have shown that Home Hospitalization (HAD) improves clinical outcomes, reduces complications, lowers readmission rates, and generates substantial cost savings (15-17). In parallel, digital health technologies -including remote patient monitoring, mobile applications, and artificial intelligence- have demonstrated benefits in the early detection of clinical changes and in enhancing patient safety in home-based care settings (18-21).
It is within this context that the eSalut Program emerges, a digital platform developed to support active monitoring of patients admitted to HAD. The system integrates daily symptom reports, follow-up questionnaires, personalized educational exercises, automated clinical alert generation, and communication channels with the care team, with the aim of improving clinical decision-making and strengthening patient engagement by enabling active monitoring of their clinical status.
At the Hospital Universitari Germans Trias i Pujol (HUGTiP), the progressive deployment of the eSalut Program within the HAD service represents a unique opportunity to generate rigorous and valuable evidence for the healthcare system. The Program has been specifically designed to support acute clinical monitoring, integrating functionalities such as symptom tracking, automated alert generation, transmission of structured data, and protocol-based clinical response. These features may enhance early detection of clinical issues, reduce complications, and increase patient safety during home-based hospitalization.
In this context, the investigators pose the following research question: does the integration of the eSalut Program into Home Hospitalization (HAD) improve clinical outcomes and reduce unplanned events in patients with acute conditions? The hypothesis of the study is that the use of the eSalut Program will enable earlier detection of complications, a reduction in adverse incidents, and an overall improvement in clinical response.
The primary objective of this study is to assess the impact of the eSalut Program on patients admitted to HAD through a randomized clinical trial, analyzing clinical outcomes, generated alerts, complications, unplanned returns, and 30-day readmissions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
The statistical analysis service anonymized the patients involved.
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
- •≥18 years old
- •Admitted to HAD
- •Ability to read Spanish/Catalan
- •Minimum digital literacy
- •Smartphone/tablet with Android or iOS
- •Ability to answer calls and handle the App
- •Patient or caregiver can manage the device
排除标准
- •Patients living in nursing homes
- •Voluntary withdrawal
- •Complications requiring admission unrelated to study
- •Loss of patient or caregiver
- •No mobile device available
研究组 & 干预措施
eSalut Program arm
Patients admitted to home hospitalization who will use the eSalut digital platform with symptoms monitoring, alerts and communication with the care team.
干预措施: eSalut program arm (Other)
Control arm
Patients admitted to home hospitalization receiving conventional care without the eSalut digital platform.
干预措施: Control arm (Other)
结局指标
主要结局
Number of Participants With Hospital Readmission Within 30 Days After Discharge From Hospital-at-Home
时间窗: 30 days post discharge
Number of participants who experience at least one unplanned hospital readmission within 30 days after discharge from the Hospital-at-Home program.
次要结局
- Length of Stay in Hospital-at-Home (Days)(From admission (day 0) to discharge (up to 30 days))
- Source of Clinical Alerts During Hospital-at-Home(Up to 30 days after Hospital-at-Home admission)
- Number of Participants With Unplanned Return to Hospital During Hospital-at-Home(Up to 30 days after Hospital-at-Home admission)
- Number of Healthcare Visits by Modality During Hospital-at-Home(Up to 30 days after Hospital-at-Home admission)
- Patient Empowerment Score Assessed by the 47-item Patient Empowerment in Chronic Conditions Questionnaire (CEPEC-47)(Baseline and at discharge from Hospital-at-Home (mean 15 days))
- Health Literacy Score Assessed by the 16-item European Health Literacy Survey Questionnaire (HLS-EU-Q16)(Baseline and at discharge from Hospital-at-Home (mean 15 days))
- Patient Activation Score Assessed by the 13-item Patient Activation Measure (PAM-13)(Baseline and at discharge from Hospital-at-Home (mean 15 days))
- Medication Adherence Score Assessed by the Adherence to Refills and Medications Scale (ARMS-e)(Baseline and at discharge from Hospital-at-Home (mean 15 days))
- Anxiety and Depression Scores Assessed by the Hospital Anxiety and Depression Scale (HADS)(Baseline and at discharge from Hospital-at-Home (mean 15 days))
- Patient or Primary Caregiver Satisfaction Score With Hospital-at-Home Care(One week after Hospital-at-Home discharge)