NCT04898452

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jul 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Jul 2020Dec 2026

First Submitted

Initial submission to the registry

July 1, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

5.5 years

First QC Date

July 1, 2020

Last Update Submit

June 17, 2025

Conditions

Keywords

Home Care Services, Hospital-BasedTelemedicineHome Infusion TherapyHospital at homeAntibiotics

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

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

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

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

Interventions

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 professionalsNext of kinPatients needing antibiotics infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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)

You may not qualify if:

  • consent not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helse Møre og Romsdal HF, Kristiansund sjukehus, Medisinsk Avdeling

Kristiansund, Norway

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Telemedicine

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Torstein Hole, md phd

    Møre og Romsdal Hospital Trust

    STUDY DIRECTOR

Central Study Contacts

Inger Stokke, MSc

CONTACT

Ann Iren Kjønnøy, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

May 24, 2021

Study Start

July 2, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

June 22, 2025

Record last verified: 2025-06

Locations