Clinical Assessment and Treatment in the Nursing Home as an Alternative to Hospital Admission
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCopenhagen University Hospital at Herlev
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Home-based Clinical Assessment and Treatment
Other interventionNursing 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.
Treatment groups
9,000 Participants
are divided into 2 treatment groupsGroup A: Home-based assessment and treatmentExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
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 monthsSecondary 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 monthsOther outcomes
1
Nursing home resident experience (qualitative)
Evaluation through semi-structured interviews
Time frame
One month after clinical assessment2
Healthcare personal experience (qualitative)
Evaluation through semi-structured interviews
Time frame
6 months after enrollment of nursing homeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Copenhagen University Hospital at Herlev
Lead sponsor
Herlev and Gentofte Hospital
Collaborator
Amager Hospital
Collaborator
Bispebjerg Hospital
Collaborator
Nordsjaellands Hospital
Collaborator
Source ClinicalTrials.gov