Intravenous Antibiotic Treatment at Home (Hosp@Home)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infection
• Intervention / Treatment: Other: A new model of interaction across health services with use of welfare technology and telemedicine

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Inger Stokke, MSc; Phone Number: +47 41928023; Email: inger.stokke@helse-mr.no
• Study Contact Backup: Name: Ann Iren Kjønnøy, MSc; Email: Ann.Iren.Kjonnoy@helse-mr.no

Study Locations

• Norway
  • Kristiansund, Norway
    • Recruiting
    • Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling
    • Contact: Inger Stokke, MSc; Email: inger.stokke@helse-mr.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients participate in both study part 1 (qualitative) and study part 2 (quantitative). Health professionals and next to kins participate in study part 1 (qualitative).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helse Møre og Romsdal HF
• Collaborators: SINTEF Health Research; Kristiansund municipality; Centre for Health Innovation; Hospital Pharmacy of Central Norway Trust

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Antibiotics; Hospital at home; Home Care Services, Hospital-Based; Home Infusion Therapy
• Other Study ID Numbers: 2019/60

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No