Clinical trial NCT04898452: Intravenous Antibiotic Treatment at Home
Official title: Intravenous Antibiotic Treatment at Home: A New Model for Across Services Interaction With the Use of Welfare Technology and Telemedicine.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: Home Care Services, Hospital-Based
Telemedicine
Home Infusion Therapy
Hospital at home
Antibiotics
Lead sponsor: Helse Møre og Romsdal HF
Sponsor class: OTHER_GOV
Collaborators: name: SINTEF Health Research
name: Kristiansund municipality
name: Centre for Health Innovation
name: Hospital Pharmacy of Central Norway Trust
First posted: 2021-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.

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

Primary outcomes:
measure: number of rehospitalisations
timeFrame: 45 months
measure: patient satisfaction
timeFrame: 45 months
measure: health personnel's opinion on patient safety
timeFrame: 45 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kristiansund
country: Norway
facility: Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling
Study officials:
affiliation: Møre og Romsdal Hospital Trust
name: Torstein Hole, md phd
role: STUDY_DIRECTOR
References: