NCT07756554

Brief Summary

This multicenter, cluster-randomized, unblinded quality-improvement study evaluates whether home-based clinical assessment by municipal acute care teams can safely reduce hospital admissions among nursing home residents experiencing acute illness or clinical deterioration during out-of-hours periods. Participating nursing homes in the Capital Region of Denmark will be randomized to either usual care (contacting the regional medical helpline, 1813) or the intervention pathway, in which nursing home staff contact a municipal acute care team directly. The acute care team performs an on-site clinical assessment and, when needed, consults a senior physician in the hospital emergency department to establish a treatment and observation plan, which may include continued management at the nursing home under hospital responsibility. The study compares the intervention with usual care with respect to hospital admissions and mortality among nursing home residents.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
9,000

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Feb 2026

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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 Progress29%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

August 3, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

hospital at homeadmission avoidancehome-based treatmentnursing home residentsHospital-at-HomeHaHHITHHospital in the home

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    Time to death from any cause, compared between intervention and usual care groups using time-to-event methods.

    From date of randomization until date of death from any cause, up to 48 weeks.

  • Time to first hospital admission

    Time to first acute hospital admission, compared between intervention and usual care groups using time-to-event methods.

    From date of randomization until the date of first acute admission to emergency department or hospital, up to 48 weeks.

Secondary Outcomes (3)

  • Initial Disposition After Assessment by the Municipal Acute Care Team

    At completion of the index assessment, up to 6 hours.

  • Number of emergency contacts (both groups)

    From date of randomization until the end of follow-up, up to 48 weeks.

  • Total healthcare cost per nursing home resident

    From date of randomization until the end of follow-up, up to 48 weeks.

Other Outcomes (2)

  • Nursing home resident experience (qualitative)

    One month after clinical assessment

  • Healthcare personal experience (qualitative)

    6 months after enrollment of nursing home

Study Arms (2)

Home-based assessment and treatment

EXPERIMENTAL

The intervention group

Other: Home-based Clinical Assessment and Treatment

Standard care

NO INTERVENTION

The control group

Interventions

Nursing homes in the intervention group will, if a resident experiences acute illness or clinical deterioration, call the municipal acute care team directly. They will then do a home-based clinical assessment and, if deemed necessary, consult a senior physician in the hospital emergency or geriatrics department to establish a treatment and observation plan.

Home-based assessment and treatment

Eligibility Criteria

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

You may qualify if:

  • Nursing homes, defined as long-term care facilities with care personnal available 24/7 for residents with need for continued medical care
  • Nursing homes located in the Capital Region of Denmark
  • Nursing homes accepting participation and cluster randomization

You may not qualify if:

  • Assisted living facilities, intermediate/temporary care units, rehabilitation units, hospices, or other non-nursing-home setting.
  • Nursing homes located on the island of Bornholm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Copenhagen University Hospital - Bispebjerg and Frederiksb

Copenhagen, Denmark

RECRUITING

University Hospital of Copenhagen Herlev

Herlev, Denmark

RECRUITING

Copenhagen University Hospital - North Zealand Hospital

Hillerød, Denmark

RECRUITING

University Hospital of Copenhagen Amager and Hvidovre

Hvidovre, Denmark

RECRUITING

MeSH Terms

Conditions

Clinical DeteriorationInfectionsDehydrationAgnosia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Disease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Kasper K Iversen, MD, Professor

    University Hospital of Copenhagen Herlev and Gentofte

    STUDY CHAIR

Central Study Contacts

Josephine L Nielsen, MD

CONTACT

Maria N Larsen, MD, PhD

CONTACT

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 clusterrandomized non-blinded trial. Randomisation with be in the ratio 1:5 on a nursing home level.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 10, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08

Locations