Intravenous Antibiotic Treatment at Home

NCT ID: NCT04898452

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients needing antibiotics infusion

Patients needing antibiotics infusion A new model of interaction across health services with use of welfare technology and telemedicine 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.

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

Intervention Type: 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.

Next of kin

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

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

Intervention Type: 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.

Health professionals

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

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SINTEF Health Research

OTHER

Sponsor Role: collaborator

Kristiansund municipality

UNKNOWN

Sponsor Role: collaborator

Centre for Health Innovation

UNKNOWN

Sponsor Role: collaborator

Hospital Pharmacy of Central Norway Trust

UNKNOWN

Sponsor Role: collaborator

Helse Møre og Romsdal HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torstein Hole, md phd

Role: STUDY_DIRECTOR

Møre og Romsdal Hospital Trust

Locations

Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling

Kristiansund, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Inger Stokke, MSc

Role: CONTACT

inger.stokke@helse-mr.no

+47 41928023

Ann Iren Kjønnøy, MSc

Role: CONTACT

Ann.Iren.Kjonnoy@helse-mr.no

Facility Contacts

Inger Stokke, MSc

Role: primary

inger.stokke@helse-mr.no

Other Identifiers

2019/60

Identifier Type: -

Identifier Source: org_study_id