ClinicalTrials.gg
RecruitingNCT07756554Updated Sep 2, 2026

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

An interventional study of Home-based Clinical Assessment and Treatment in Nursing Homes Residents, Deterioration, Clinical and Infection, sponsored by Copenhagen University Hospital at Herlev. Recruiting at 4 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Copenhagen University Hospital at Herlev · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2026, registered Aug 2026).
  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
9,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Nursing Homes Residents
  • Deterioration, Clinical
  • Infection
  • Dehydration
  • Pain Management

Keywords

  • hospital at home
  • admission avoidance
  • home-based treatment
  • nursing home residents
  • Hospital-at-Home
  • HaH
  • HITH
  • Hospital in the home
03

In context

Clinical Deterioration

47 studies on the registry are indexed under Clinical Deterioration; 15 are open to participants now.

This study's planned enrollment of 9,000 is above the median of 375 across 21 interventional studies indexed under Clinical Deterioration.

Browse Clinical Deterioration studies →

Lead sponsor

Copenhagen University Hospital at Herlev is the lead sponsor of 77 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Clusters (Nursing Homes):

Inclusion criteria

Inclusion Criteria:

  • 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

Exclusion criteria

Exclusion criteria

  • Assisted living facilities, intermediate/temporary care units, rehabilitation units, hospices, or other non-nursing-home setting.
  • Nursing homes located on the island of Bornholm
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9,000 participants (estimated)

Study arms

  • Experimental
    Home-based assessment and treatment

    The intervention group

    Other: Home-based Clinical Assessment and Treatment

  • No intervention
    Standard care

    The control group

Interventions

  • OtherHome-based Clinical Assessment and Treatment

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  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)

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

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

Other outcomes

  1. Nursing home resident experience (qualitative)

    Evaluation through semi-structured interviews

    Time frame: One month after clinical assessment

  2. Healthcare personal experience (qualitative)

    Evaluation through semi-structured interviews

    Time frame: 6 months after enrollment of nursing home

07

Study locations

4 of 4 sites recruiting
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07756554
Lead sponsor
Copenhagen University Hospital at Herlev
Collaborators
Herlev and Gentofte Hospital, Amager Hospital, Bispebjerg Hospital, Nordsjaellands Hospital
Responsible party
Josephine Lund Nielsen (Principal Investigator, Copenhagen University Hospital at Herlev) — Principal investigator
First posted
Aug 10, 2026
Start date
Feb 1, 2026
Primary completion
Jun 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Josephine L Nielsen, MD
Contact
josephine.lund.nielsen@regionh.dk
+4527156091
Maria N Larsen, MD, PhD
Contact
maria.normand.larsen@regionh.dk
+4540314282
Kasper K Iversen, MD, Professor
study chair · University Hospital of Copenhagen Herlev and Gentofte

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion