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临床试验/NCT04898452
NCT04898452进行中(未招募)不适用

Intravenous Antibiotic Treatment at Home: A New Model for Across Services Interaction With the Use of Welfare Technology and Telemedicine.

Helse Møre og Romsdal HF2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
19
试验地点
2
主要终点
number of rehospitalisations

研究概览

简要总结

The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. This model will first be tested for use in intravenous antibiotic therapy. The results of the study will be used to further develop the service. In the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.

详细描述

This research-based innovation study has an evaluation approach with follow-up evaluation as the overall approach.

The pre-project was carried out with a qualitative approach under the auspices of SINTEF 2018/2019.

The main project consists of sub-study 1 and sub-study 2 (2020/2022).

Sub-study 1: The project use an iterative, user-centered service methodology with a qualitative approach. Here, SINTEF has the main responsibility for a qualitative summary after conducting interviews, observations and group discussions with patients, next of kins and health professionals regarding the development and testing / quality assurance of the new concept / service course for home treatment.

Sub-study 2: The approach here is quantitative. Descriptive data must be obtained from the hospital and municipal patient records, patient administration system (PAS) at Kristiansund hospital, alarm data from the Regional Response Center and pump log from the individual patient's infusion pump after home treatment.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • Main or bi-diagnosis during stay:
  • A692 Borreliosis G00 - G009 Central nervous system inflammatory disorders I33 Endocarditis J86 Empyema D46.3 Spondylodiscitis M86 Osteomyelitis T84 Prosthesis / osteosynthesis infections M00.0-M00.9 Pyogen / septic arthritis J40-J47 Chronic diseases of the lower respiratory tract
  • Competent to give consent
  • The infection can not be treated with oral antibiotics in monotherapy
  • Selected IV antibiotics must be suitable for administration via selected pumps
  • The patient's condition is stable and does not require frequent observation by health care professionals
  • The patient is motivated and willing to participate in intravenous treatment in home hospitals
  • Must, after training, demonstrate mastery of practical procedures related to pump handling and any other procedures described in the patient's treatment plan
  • The home must be suitable for intravenous antibiotic treatment; access to refrigerators, hygienic conditions, social conditions
  • The patient must have a mobile phone and be able to handle the system for fast and secure communication with the Regional Response Center (RRO)

排除标准

  • consent not given

结局指标

主要结局

number of rehospitalisations

时间窗: 45 months

patient satisfaction

时间窗: 45 months

assessed with semi-structured interview

health personnel's opinion on patient safety

时间窗: 45 months

based on answers in web-case-registration-form (CRF)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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