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NCT Number: NCT04898452

Intravenous Antibiotic Treatment at Home

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling

Kristiansund, Norway

Location status: Recruiting

Location contact

Inger Stokke, MSc

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • consent not given

Treatment and study plan

A new model of interaction across health services with use of welfare technology and telemedicine

Other

Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course.

Primary outcomes

  1. number of rehospitalisations

    Time frame: 45 months

  2. patient satisfaction

    Time frame: 45 months

    assessed with semi-structured interview

  3. health personnel's opinion on patient safety

    Time frame: 45 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Iren Kjønnøy, MSc

CONTACT

[email protected]

Inger Stokke, MSc

CONTACT

[email protected]

+47 41928023

Sponsors and collaborators

Lead sponsor

Helse Møre og Romsdal HF

Other Gov

Collaborators

  • Centre for Health Innovation
  • Hospital Pharmacy of Central Norway Trust
  • Kristiansund municipality
  • SINTEF Health Research

Registry information

Official study title

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

Acronym: Hosp@Home

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
May 24, 2021
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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