Intravenous Antibiotic Treatment at Home

Infection Clinical Trial

— Hosp@Home  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04898452
• Other study ID #: 2019/60
• Status: Recruiting
• Start date: July 2, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Helse Møre og Romsdal HF
• Contact: Inger Stokke, MSc
• Phone: +47 41928023
• Email: inger.stokke[@]helse-mr.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Norway	Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling	Kristiansund

Sponsors (5)

Lead Sponsor	Collaborator
Helse Møre og Romsdal HF	Centre for Health Innovation, Hospital Pharmacy of Central Norway Trust, Kristiansund municipality, SINTEF Health Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of rehospitalisations		45 months
Primary	patient satisfaction	assessed with semi-structured interview	45 months
Primary	health personnel's opinion on patient safety	based on answers in web-case-registration-form (CRF)	45 months