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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07756554
Enrollment
9000
Registered
2026-08-10
Start date
2026-02-01
Completion date
2027-12-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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).

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.

Sponsors

Copenhagen University Hospital at Herlev
Lead SponsorOTHER
Herlev and Gentofte Hospital
CollaboratorOTHER
Amager Hospital
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER
Nordsjaellands Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study is a clusterrandomized non-blinded trial. Randomisation with be in the ratio 1:5 on a nursing home level.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortalityFrom date of randomization until date of death from any cause, up to 7 monthsTime to death from any cause, compared between intervention and usual care groups using time-to-event methods, with non-inferiority testing.
Time to first eventFrom 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.

Secondary

MeasureTime frameDescription
Proportion of in-hospital deathsFrom date of randomization until date of death from any cause, up to 7 monthsProportion of in-hospital deaths out of all deseased nursing home residents in both the intervention and the control group.
Number of emergency contacts (both groups)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.
Initial Disposition After Assessment by the Municipal Acute Care TeamAt 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)
Proportion of end-of-life hospitalizationsFrom date of randomization until date of death from any cause, up to 7 monthsProportion of end-of-life hospitalizations, defined as hospitalizations during the last month before death, out of total number of deseased nursing home residents.
Total healthcare cost per nursing home residentFrom 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

Countries

Denmark

Contacts

CONTACTJosephine L Nielsen, MD
josephine.lund.nielsen@regionh.dk+4527156091
CONTACTMaria N Larsen, MD, PhD
maria.normand.larsen@regionh.dk+4540314282
STUDY_CHAIRKasper K Iversen, MD, Professor

University Hospital of Copenhagen Herlev and Gentofte

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026