Early Discharge - a Randomised Controlled Trial Evaluating Mental and Physical Effects on Acutely and Chronically Ill Patients in a Telemedicine Supported Virtual Hospital at Home Model
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Patient mental wellbeing (qualitative)
研究概览
简要总结
This controlled clinical trial will be part of a larger, 'virtual hospital-at-home' (vHaH) project called Influenz-er. vHaH is a care model designed to deliver medical care at home, as a substitute for a continued conventional inpatient hospital admission.
The overall aim of Influenz-er is to develop, implement and evaluate a novel Hospital at Home model, that will enable safe and satisfactory admission of hospitalised patients including epidemic patients in their homes.
详细描述
Various versions of hospital-at-home models have been implemented as an emergency solution to a steep increase in number of hospitalisations during the COVID-19 pandemic crisis. Conventionally, epidemic patients who require medical monitoring, will be admitted to the hospital. Recently, patients hospitalised for COVID-19 requiring medical supervision for an extended period - sometimes for weeks - have been admitted to their own home supported by telemedicine and/or mobile hospital-based care team (MHCT). Various models of home-based admissions of pandemic patients have been implemented internationally with great results regarding safety and effectiveness. These models are mostly based on physical attendance of physicians in the patient's home and in most situations implemented out of need. Home-based models provide promising results regarding costs, but results are based on low-quality evidence. Health systems facing capacity constraints and rising costs needs to allocate resources based on high-quality evidence.
Therefore, further research regarding feasibility, safety, satisfaction, costs, and effectiveness of a vHaH model still needs to be done.
Danish hospital capacity will not allow for HaH models primarily depending on physical attendance of physicians in the patient's home, nor will it be possible to manually monitor all patient reported data. Therefore, there is a need for a telemedicine supported vHaH model with a smart algorithm alarming clinical staff and thereby aiding in timely handling of patient data and clinical state.
Project Influenz-er proposes an option of transfer to telemedicine supported vHaH model as an alternative to continued standard hospital admission for the future. Patient safety is a top priority regarding both the utilised technology and the re-organisation of standard clinical responsibilities and tasks. Therefore, project Influenz-er included several steps prior to the effectiveness evaluation in this clinical trial.
In the present study, knowledge from previous studies under project Influenz-er is applied, and the vHaH is now ready to be evaluated in an effectiveness trial.
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
盲法说明
Masking of participants is not possible due to the nature of the study
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patients admitted to
- •the Department of Pulmonary and Infectious Diseases (DPID) under any diagnosis or
- •to the Department of Multimorbidity under any diagnosis
- •Residential address within the catchment area of North Zealand University Hospital
- •Treatment regimen which can be handled within the vHaH model
排除标准
- •Unstable clinical condition defined by a current early warning score (EWS) > 6 or single score =
- •Permanent physical or cognitive impairment or observed non-compliance that might negatively affect the ability to perform any of the required actions during the intervention such as self-measurements, data transfer by the app, and/or communication via telephone or video consultation.
- •a. This may include, but is not limited to conditions such as dementia, post-stroke sequelae, deafness, extreme tremor of the upper limbs.
- •Unproficiency in Danish language skills
- •Pregnancy
结局指标
主要结局
Patient mental wellbeing (qualitative)
时间窗: 14 days post discharge
Evaluation through semi-structured interviews
Physical activity level
时间窗: Will be measured during admission (home-based vs. hospital), an average of 5 days after study enrollment
Daily step count and time in different activity levels will be measured using an accelerometer placed on the thigh of the participant.
Patient satisfaction (quantitative)
时间窗: 14 days post discharge
Evaluation through questionnaires
Patient perceived safety (quantitative)
时间窗: 14 days post discharge
Evaluation through questionnaires
Patient mental wellbeing (quantitative)
时间窗: 14 days post discharge
Evaluation through questionnaires
Patient satisfaction (qualitative)
时间窗: 14 days post discharge
Evaluation through semi-structured interviews
Patient perceived safety (qualitative)
时间窗: 14 days post discharge
Evaluation through semi-structured interviews
次要结局
- Percentage of scheduled video consultation which were delivered(daily registration during home-based admission, an average of 5 days after study enrollment)
- Number of in-hospital days(three months post discharge)
- Number of contacts in primary care (general practitioner, physiotherapy etc.)(three months post discharge)
- Demographic characterisation of patients eligible for vHaH(14 days post discharge)
- Mortality post-discharge (7 days, 30 days, and 90 days)(7, 30 and 90 days post discharge)
- Productivity losses (resources lost when participants work at suboptimal levels or are absent from work)(three months post discharge)
- Rate of adverse events of special interest (AESI)(Immediately after discharge)
- Readmittance rate post discharge (30 days and 90 days)(30 and 90 days post discharge)
- Mortality during admission(daily registration during hospital admission or home-based admission, an average of 5 days after study enrollment)
- Percentage of timely service delivery in response to red alarms as a sign of clinical deterioration (health workers demonstrate adequate ability in telemedicine service delivery).(daily registration during home-based admission, an average of 5 days after study enrollment)
- Number of health care provider dashboard deficiencies(daily registration during home-based admission, an average of 5 days after study enrollment)
- Costs related to initiation of home-based admission(three months post discharge)
- Number of outpatient visits(three months post discharge)
- Number of patient app deficiencies for participants enrolled in intervention arm(daily registration during home-based admission, an average of 5 days after study enrollment)
- Costs of hospital resource use(three months post discharge)
- Costs of primary care resource use(three months post discharge)
- Total costs of health care utilisation per patient(three months post discharge)
- Health-related Quality of Life(three months post discharge)