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临床试验/NCT05087082
NCT05087082已完成不适用

Early Transfer of Hospitalized Patients Including COVID-19 Patients to a Virtual Hospital at Home(vHaH)Model -a Clinical Feasibility Study.

Nordsjaellands Hospital2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
2
主要终点
Percentage of all non-acute contact requests from patients handled within pre-defined time

研究概览

简要总结

This study 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 in the home, as a substitute for a continued inpatient hospital admission. This study will be a clinical feasibility study, which will be used to guide the framing and design of the final telemedicine supported vHaH model for hospitalized patients.

详细描述

This study 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 in the home, as a substitute for a continued inpatient hospital admission. An underlying rationale for the development of vHaH is that, by avoiding the hospital environment, fragile and older persons may experience high-quality care that is associated with fewer complications, and higher treatment satisfaction for patients and their families. Various versions of home-hospital models have been implemented during the COVID-19 pandemic crisis, but in many situations out of need and so far, only very limited documented experience from sound research approaches is available in the medical literature. This study will be a clinical feasibility study, which will be used to guide the framing and design of the final telemedicine supported vHaH model for hospitalized patients including epidemic patients. We apply our experience from 5 months of clinical small scale testing (Sept 2021 - Jan 2022) of the light version of the final vHaH model on hospitalized patients (the technology and workflows of the vHaH model were tested by in-patients under their hospital stay) to implement this novel model in the safest possible way. The vHaH model will be offered exclusively to moderately ill (not severely ill) patients with respiratory infections including COVID-19.

The overall aim of Influenz-er, is to develop and implement a novel telemedicine monitoring and communication model, that will enable safe admission of epidemic patients in their homes. We will implement this novel model in the safest possible way, and initially offer the vHaH model to patients conventionally admitted with COVID-19 illness or other lower respiratory tract infections causing pneumonia. Conversion to vHaH admission will be effectuated after an assessment by a medical infectious disease specialist if the patient is assessed to be ready to continue the hospital admission safely from home, under continued monitoring and treatment responsibility by the hospital.

Based on a Cochrane review this innovative alternative to conventional hospitalization, is expected to benefit patients who will remain in the comfort of their own homes. This model could potentially increase patient and next of kin quality of life and treatment satisfaction, decrease risks of nosocomial complications and increase availability of emotional support from next of kin.

A hospital based Virtual Epidemic Center (VEC) is the center of the project, from where medical staff will monitor and communicate with patients admitted at home. Vital parameters and patient reported outcomes will be collected using a smart phone/tablet-based app. All data will be collected and processed in an algorithm to predict the impact of changes on disease severity. Algorithm and direct patient data will be displayed in real-time at the hospital in the VEC, allowing medical staff to continuously monitor their patients. In addition, daily virtual ward rounds conducted by staff in the VEC and when relevant by medical doctors (MD) from specialties of relevance to the patients' illness(es) will ensure close communication and relevant clinical assessments. A mobile medical team consisting of nurses and medical doctors (MD), will perform in-person patient evaluations, administer medication and perform other required daytime routine medical tasks.

The Influenz-er project governance structure consists of a Steering Committee with representation by the project partners Nordsjællands Hospital, University of Southern Denmark and Innovation Fund Denmark, an international Advisory Board and a national Consulting Group. Head of Clinical Research at Nordsjællands Hospital, Professor Thea Kølsen Fischer is principle investigator and project manager. The project team includes clinical experts with expertise within management of COVID-19 as well as health economic senior experts, PhD students, administrative research and innovation coordinators and health tech developers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for patients:
  • Age ≥ 18 years of age
  • Signed informed written and oral consent
  • Lower tract respiratory infections, including contagious infection (e.g. SARS CoV 2 and Influenza).
  • Considered not ready for discharge for at least 24 hours, assessed by attending MD in the COVID-19 ward.
  • Patients are self-reliant or receives sufficient formal care to be care-independent of primary informal caregiver
  • - Medically eligible for vHaH, including but not solely dependent of following conditions, assessed by the attending VEC MD:
  • Actual condition assessed to be clinically stable.
  • Green or yellow-tag triage based on vital parameters, including total adjusted EWS-score ≤6 and no adjusted single parameter score of 3 or above (See appendix 1)
  • Requires less than 5L/min of oxygen supplement
  • Stable or decreasing need for oxygen supplement
  • Stable or decreasing paraclinical infection parameters such as C-reactive protein (CRP) etc.
  • Home-based admission will be located within catchment area of the hospital (according to the official address of the individual).

排除标准

  • Patients who cannot participate in interaction via App
  • Lack of sufficient Danish language skills to understand and interact with requirements and staff at a patient safe level
  • Patient residency cannot offer isolated room (COVID-19 patients only)
  • Pregnancy
  • Inclusion criteria specific for primary informal caregivers (if any)
  • Signed informed written and oral consent
  • Study patient is included in the study
  • Age ≥ 18 years

结局指标

主要结局

Percentage of all non-acute contact requests from patients handled within pre-defined time

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Percentage of all planned daily video supported ward rounds provided

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Percentage of all red alarms triggered by EWS-change handled within pre-defined time

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Percentage of all yellow alarms triggered by EWS-change handled within pre-defined time

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Number of recruited participants

时间窗: through study completion, approximately 18 months

recruitment success is defined as 80%

Number of drop-out participants

时间窗: through study completion, approximately 18 months

success is defined by brop out less than 10%

Percentage of all planned self-measurements transmitted by patient

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Percentage of all acute contact requests from patients handled within pre-defined time

时间窗: through study completion, approximately 18 months

successful protocol adherence is defined by 80%

Number and type of outcome assessment completed by participants.

时间窗: through study completion, approximately 18 months

次要结局

  • Organizational related endpoints: Number of contacts to general practitioner(Three months after discharge of patient)
  • Patient related endpoints: Self-perceived quality of care(Three months after discharge of patient)
  • Organizational related endpoints: Costs of hospital resource use(Three months after discharge of patient)
  • Organizational related endpoints: Number of outpatient visits(Three months after discharge of patient)
  • Organizational related endpoints: Productivity losses(Three months after discharge of patient)
  • Patient related endpoints: Compound of clinical events(30 days efter the discharge.)
  • Patient related endpoints: Loss of function(Three months after discharge)
  • Organizational related endpoints: Costs of general practitioner resource use(Three months after discharge of patient)
  • Organizational related endpoints: Total costs of health care utilization per patient(Three months after discharge of patient)
  • Organizational related endpoints: Intervention costs(Three months after discharge of patient)
  • Patient related endpoints: Productivity losses(Three months after discharge of patient)
  • Next of kin related endpoints: Caregiver strain(Two weeks after discharge of the patient)
  • Next of kin related endpoints: Productivity losses(Three months after discharge of patient)
  • Organizational related endpoints: Number of in-hospital days(Three months after discharge of patient)
  • Health-related Quality of Life(Three months after discharge of patient)
  • Next of kin related endpoints: Quality of Life(Three months after discharge of patient)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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