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

August 31, 2026 updated by: Josephine Lund Nielsen, Copenhagen University Hospital at Herlev

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

9000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen University Hospital - Bispebjerg and Frederiksb
      • Herlev, Denmark
        • Recruiting
        • University Hospital of Copenhagen Herlev
      • Hillerød, Denmark
        • Recruiting
        • Copenhagen University Hospital - North Zealand Hospital
      • Hvidovre, Denmark
        • Recruiting
        • University Hospital of Copenhagen Amager and Hvidovre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Clusters (Nursing Homes):

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard care
The control group
Experimental: Home-based assessment and treatment
The intervention group
Other: Home-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first event
Time Frame: From date of randomization until the date of first event, up to 7 months.
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.
From date of randomization until the date of first event, up to 7 months.
All-cause mortality
Time Frame: From date of randomization until date of death from any cause, up to 7 months
Time to death from any cause, compared between intervention and usual care groups using time-to-event methods, with non-inferiority testing.
From date of randomization until date of death from any cause, up to 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Disposition After Assessment by the Municipal Acute Care Team
Time Frame: At completion of the index assessment, up to 6 hours.

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)
At completion of the index assessment, up to 6 hours.
Number of emergency contacts (both groups)
Time Frame: From date of randomization until the end of follow-up, up to 48 weeks.
Number of contacts to 1813 or the municipal acute care team, respectively, during follow-up period.
From date of randomization until the end of follow-up, up to 48 weeks.
Total healthcare cost per nursing home resident
Time Frame: From date of randomization until the end of follow-up, up to 48 weeks.

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
From date of randomization until the end of follow-up, up to 48 weeks.
Proportion of in-hospital deaths
Time Frame: From date of randomization until date of death from any cause, up to 7 months
Proportion of in-hospital deaths out of all deseased nursing home residents in both the intervention and the control group.
From date of randomization until date of death from any cause, up to 7 months
Proportion of end-of-life hospitalizations
Time Frame: From date of randomization until date of death from any cause, up to 7 months
Proportion of end-of-life hospitalizations, defined as hospitalizations during the last month before death, out of total number of deseased nursing home residents.
From date of randomization until date of death from any cause, up to 7 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nursing home resident experience (qualitative)
Time Frame: One month after clinical assessment
Evaluation through semi-structured interviews
One month after clinical assessment
Healthcare personal experience (qualitative)
Time Frame: 6 months after enrollment of nursing home
Evaluation through semi-structured interviews
6 months after enrollment of nursing home

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Bispebjerg Hospital
Amager Hospital
Herlev and Gentofte Hospital
Nordsjaellands Hospital

Investigators

  • Study Chair: Kasper K Iversen, MD, Professor, University Hospital of Copenhagen Herlev and Gentofte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 3, 2026

First Submitted That Met QC Criteria

August 6, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital in the Nursing Home

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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