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NCT Number: NCT07756554

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital - Bispebjerg and Frederiksb, Copenhagen, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based Clinical Assessment and Treatment

Other

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.

Primary outcomes

  1. All-cause mortality

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

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

  2. Time to first hospital admission

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

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

Secondary outcomes

  1. 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)
  2. 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.

  3. 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

Other outcomes

  1. Nursing home resident experience (qualitative)

    Time frame: One month after clinical assessment

    Evaluation through semi-structured interviews

  2. Healthcare personal experience (qualitative)

    Time frame: 6 months after enrollment of nursing home

    Evaluation through semi-structured interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Josephine L Nielsen, MD

CONTACT

[email protected]

+4527156091

Maria N Larsen, MD, PhD

CONTACT

[email protected]

+4540314282

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital at Herlev

Other

Collaborators

  • Amager Hospital
  • Bispebjerg Hospital
  • Herlev and Gentofte Hospital
  • Nordsjaellands Hospital

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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