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Nursing Homes ResidentsNCT07756554

Clinical Assessment and Treatment in the Nursing Home as an Alternative to Hospital Admission

A study testing Home-based Clinical Assessment and Treatment in people with Nursing Homes Residents and Deterioration, Clinical, run by Copenhagen University Hospital at Herlev at 4 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home-based Clinical Assessment and Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9,000 participants
Where
4 sitesDenmark
Study dates
1 Feb 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Josephine L Nielsen, MD contact

+4527156091

josephine.lund.nielsen@regionh.dk

Maria N Larsen, MD, PhD contact

+4540314282

maria.normand.larsen@regionh.dk

Denmark4 sites, 4 recruiting
  • Copenhagen University Hospital - Bispebjerg and Frederiksb

    Copenhagen

    Recruiting
  • University Hospital of Copenhagen Herlev

    Herlev

    Recruiting
  • Copenhagen University Hospital - North Zealand Hospital

    Hillerød

    Recruiting
  • University Hospital of Copenhagen Amager and Hvidovre

    Hvidovre

    Recruiting

Other trials in Denmark

About this study

Official title: Home-Based Assessment and Treatment by Municipal Acute Care Teams Combined With Remote Senior Physician Consultation as an Alternative to Hospital Admission for Nursing Home Residents: A Multicenter Randomized Controlled Trial

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.

Read the detailed description

Background and Rationale:

Nursing home residents represent one of the most vulnerable populations in the healthcare system. Most residents are older adults with multiple chronic conditions, frailty, reduced functional capacity, and a high risk of adverse outcomes associated with hospitalization. Hospital admissions may lead to complications such as delirium, hospital-acquired infections, functional decline, and reduced quality of life.

In Denmark, all nursing home residents are registered with a general practitioner, who is responsible for addressing medical issues requiring physician assessment during regular office hours (Monday through Friday 08:00-16:00). During out-of-hours periods, nursing home staff often have limited access to medical assessment and decision support. Municipal acute care teams, staffed by experienced nurses, possess substantial clinical competencies; however, access to physician consultation is often limited during evenings, weekends, and public holidays. Consequently, nursing home residents may be referred to an emergency department or admitted to hospital in situations where clinical assessment and treatment within the nursing home could potentially represent a safe and appropriate alternative.

This study evaluates a new cross-sector care model developed through collaboration between municipalities, municipal acute care teams and hospitals in the Capital Region of Denmark. The model combines home-based clinical assessment by municipal acute care teams with remote consultations with senior physicians from the emergency or geriatrics department. The overall aim is to improve access to timely clinical decision-making, provide treatment in familiar surroundings whenever appropriate, and reduce potentially avoidable hospital admissions.

Study Design:

This is a multicenter, cluster-randomized, unblinded quality-improvement study conducted among nursing homes in the Capital Region of Denmark. Nursing homes are randomized to either the intervention pathway or usual care.

The intervention is implemented during out-of-hours periods, defined as weekdays between 16:00 and 22:00 and weekends and public holidays between 08:00 and 22:00. During these periods, participating intervention nursing homes follow the study pathway, whereas control nursing homes continue standard practice. During regular office hours (Monday through Friday 08:00-16:00) both groups contact the general practitioner as usual, and during nights (22:00-08:00), both groups contact the regional medical helpline, 1813.

Before contacting external healthcare services, nursing home staff in both groups always perform an initial assessment including measurement of vital signs and evaluation of the resident's clinical condition. Residents with immediately life-threatening conditions continue to be managed through standard emergency medical services (112).

The study includes an initial run-in period (1 February-1 September 2026) to optimize implementation of the intervention. Following the run-in period, a new cluster randomization with an increased number of intervention nursing homes will be performed before the start of the main data collection.

Intervention (Home-Based Care Program):

Nursing homes randomized to the intervention arm will, whenever a resident requires urgent clinical assessment during out-of-hours periods, call the municipal acute care team directly instead of the regional medical helpline (1813). The acute care team may manage and conclude the case directly by phone, or they may conduct an on-site comprehensive clinical assessment first. When physician input is required, the acute care team consults a senior physician from the emergency or geriatrics department by telephone or video conference.

Following this remote consultation, a treatment and/or observation plan is established. Possible outcomes of include:

  • Management and discharge at the nursing home with advice and minor interventions.
  • Follow-up by the resident's general practitioner on the next working day.
  • Home-based treatment under hospital responsibility with planned follow-up from the municipal acute care team (Hospital-at-Home, HaH).
  • Subacute outpatient assessment at the hospital.
  • Assessment by a mobile physician service.
  • Acute hospital admission when clinically indicated.

Control Group:

Nursing homes in the control group will follow standard care when a resident experiences acute illness or clinical deterioration during out-of-hours periods, that is, call the regional medical helpline, 1813.

Data Collection and Analysis:

Data on the primary outcomes will be collected by physicians employed at Copenhagen University Hospital - Herlev and Gentofte. Data on disposition following the initial assessment will be recorded by nurses from the municipal acute care teams and subsequently collected by the study physicians. Statistical analyses will be performed by the study physicians in collaboration with a biostatistician from the University of Copenhagen. The study findings will be submitted for publication in peer-reviewed scientific journals.

Sample Size and Run-in Period:

This is a pragmatic quality-improvement study. All municipalities in the Capital Region of Denmark, with the exception of Bornholm, have been invited to participate, and all nursing homes within participating municipalities are eligible for inclusion. Consequently, the final sample size will depend on the number of participating municipalities and nursing homes during the study period. Although the study is ongoing, data collection for the main analyses has not yet commenced. A statistical power calculation based on the expected sample size will therefore be performed before initiation of the primary data collection to estimate the study's power to detect clinically relevant differences in the primary outcomes.

An initial run-in period was conducted from 1 February to 1 September 2026 to evaluate and optimize implementation of the intervention. Following this period, a new cluster randomization with an increased number of intervention nursing homes will be performed before commencement of the main study period.

Ethical Considerations:

The study is classified as a quality-improvement initiative and therefore does not require approval from the National Committee on Health Research Ethics. It has been approved by the regional research governance office of the Capital Region of Denmark (P-2026-21209).

Being tested
Home-based Clinical Assessment and Treatment
Keywords
hospital at home, admission avoidance, home-based treatment, nursing home residents, Hospital-at-Home, HaH, HITH, Hospital in the home
Medical subject headings
Clinical Deterioration, Infections, Dehydration, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based Clinical Assessment and TreatmentOther

    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.

Study groups in NCT07756554
Study groupRoleWhat they receive
Home-based assessment and treatmentExperimentalThe intervention group
Receives: Other: Home-based Clinical Assessment and Treatment
Standard careNo interventionThe control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first event

    Time to first event defined as either "acute hospital admission" or "death from any cause", compared between intervention and usual care groups using time-to-event methods, with superiority testing.

    Measured: From date of randomization until the date of first event, up to 7 months.

  2. All-cause mortality

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

    Measured: From date of randomization until date of death from any cause, up to 7 months

Secondary outcomes (5)
  1. Initial Disposition After Assessment by the Municipal Acute Care Team

    Distribution of contacts according to the immediate disposition following assessment by the municipal acute care team. Disposition categories include:

    • Telephone guidance
    • On-site clinical assessment by the municipal acute care team
    • Consultation with a hospital physician (telephone or video)
    • Contact with the emergency medical services (112)
    • Contact with the regional medical helpline (1813)

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

  2. Number of emergency contacts (both groups)

    Number of contacts to 1813 or the municipal acute care team, respectively, during follow-up period.

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

  3. Total healthcare cost per nursing home resident

    Economic evaluation comparing the intervention and control groups based on the mean total cost per nursing home resident (DKK) during the follow-up period. Multiple resource measures will be collected. These include:

    • number of home visits by the minicipal acute care team
    • time spent per visit
    • number of remote consultations with on-call physician
    • DRG-based costs (DKK) for hospital admissions and outpatient contacts

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

  4. Proportion of in-hospital deaths

    Proportion of in-hospital deaths out of all deseased nursing home residents in both the intervention and the control group.

    Measured: From date of randomization until date of death from any cause, up to 7 months

  5. Proportion of end-of-life hospitalizations

    Proportion of end-of-life hospitalizations, defined as hospitalizations during the last month before death, out of total number of deseased nursing home residents.

    Measured: From date of randomization until date of death from any cause, up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start1 Feb 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a clusterrandomized non-blinded trial. Randomisation with be in the ratio 1:5 on a nursing home level.
Masking
None (open label)
Enrolment
9,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07756554
Sponsor's protocol ID
Hospital in the Nursing Home
Status last verified
Aug 2026
First submitted
3 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Home-based Clinical Assessment and Treatment in people with Nursing Homes Residents and Deterioration, Clinical, run by Copenhagen University Hospital at Herlev at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Josephine L Nielsen, MD (+4527156091, josephine.lund.nielsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event (time frame: From date of randomization until the date of first event, up to 7 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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