NCT07458763

Brief Summary

This single-center, randomized, unblinded quality-improvement study evaluates whether a structured home-based rapid response team (RRT) intervention can safely reduce total hospital days among adults referred to the emergency department with suspected infection. Patients referred from general practitioners or the regional medical helpline (1813) between 09:00 and 22:00 are randomized 1:1 using Zelen's design to either standard in-hospital evaluation or a home-based assessment pathway delivered by a mobile clinical response team.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

February 20, 2026

Last Update Submit

March 9, 2026

Conditions

Keywords

hospital at homeadmission avoidancerapid response teamhome-based treatmentacute hospital-level care at homeinfection

Outcome Measures

Primary Outcomes (1)

  • Days Alive Outside of Hospital

    Number of days alive outside of hospital 30 days after initial referral (time of inclusion), including days receiving treatment at home.

    30 days from inclusion

Secondary Outcomes (41)

  • Suspected infection focus

    At initial clinical assessment (baseline, prior to initiation of treatment), day 0.

  • Early Warning Score, initial assessment

    At initial clinical assessment (baseline, prior to initiation of treatment), day 0

  • Contact from CTU to the patient (Intervention-group)

    Index home visit (day 0)

  • Intitial assesment at home accepted by patient (Intervention-group)

    Index home visit (day 0)

  • Response-time for inititial contact (Intervention-group)

    Index home visit (day 0)

  • +36 more secondary outcomes

Study Arms (2)

Home-based treatment

EXPERIMENTAL

The intervention group

Other: Admission avoidance Hospital at Home

Standard care

NO INTERVENTION

The control group

Interventions

The intervention group is evaluated in their homes by a mobile rapid response team to determine whether they can be safely treated at home instead of being admitted to the hospital. If deemed suitable, the patient receives treatment at home.

Home-based treatment

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or older
  • Referred with suspected infection
  • Patients must be able to provide informed consent
  • Category C or D transports (non-emergency patient transport) and self-transported patients

You may not qualify if:

  • Category A and B transport (emergency and urgent patient transport)
  • Suspected meningitis
  • Suspected sepsis
  • Suspected tropical disease
  • Suspected other time-critical infection
  • Immunodeficiency
  • Ongoing treatment with immunosuppressive/immunomodulating/chemotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Copenhagen Herlev

Herlev, Denmark

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Kasper K Iversen, MD, Prof.

    University Hospital of Copenhagen Herlev

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study is a randomized clinical non-blinded trial. Participants will be randomized in the ratio 1:1 using Zelen's design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2026

First Posted

March 9, 2026

Study Start

September 1, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations