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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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).
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Josephine L Nielsen, MD
- 전화번호: +4527156091
- 이메일: josephine.lund.nielsen@regionh.dk
연구 연락처 백업
- 이름: Maria N Larsen, MD, PhD
- 전화번호: +4540314282
- 이메일: maria.normand.larsen@regionh.dk
연구 장소
-
-
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Copenhagen, 덴마크
- 모병
- Copenhagen University Hospital - Bispebjerg and Frederiksb
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Herlev, 덴마크
- 모병
- University Hospital of Copenhagen Herlev
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Hillerød, 덴마크
- 모병
- Copenhagen University Hospital - North Zealand Hospital
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Hvidovre, 덴마크
- 모병
- University Hospital of Copenhagen Amager and Hvidovre
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: 표준 치료
대조군
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실험적: Home-based assessment and treatment
The intervention group
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to first event
기간: 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.
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From date of randomization until the date of first event, up to 7 months.
|
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All-cause mortality
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Initial Disposition After Assessment by the Municipal Acute Care Team
기간: At completion of the index assessment, up to 6 hours.
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Distribution of contacts according to the immediate disposition following assessment by the municipal acute care team. Disposition categories include:
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At completion of the index assessment, up to 6 hours.
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Number of emergency contacts (both groups)
기간: From date of randomization until the end of follow-up, up to 48 weeks.
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Number of contacts to 1813 or the municipal acute care team, respectively, during follow-up period.
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From date of randomization until the end of follow-up, up to 48 weeks.
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Total healthcare cost per nursing home resident
기간: From date of randomization until the end of follow-up, up to 48 weeks.
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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:
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From date of randomization until the end of follow-up, up to 48 weeks.
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Proportion of in-hospital deaths
기간: From date of randomization until date of death from any cause, up to 7 months
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Proportion of in-hospital deaths out of all deseased nursing home residents in both the intervention and the control group.
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From date of randomization until date of death from any cause, up to 7 months
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Proportion of end-of-life hospitalizations
기간: From date of randomization until date of death from any cause, up to 7 months
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Proportion of end-of-life hospitalizations, defined as hospitalizations during the last month before death, out of total number of deseased nursing home residents.
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From date of randomization until date of death from any cause, up to 7 months
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Nursing home resident experience (qualitative)
기간: One month after clinical assessment
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Evaluation through semi-structured interviews
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One month after clinical assessment
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Healthcare personal experience (qualitative)
기간: 6 months after enrollment of nursing home
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Evaluation through semi-structured interviews
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6 months after enrollment of nursing home
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 연구 의자: Kasper K Iversen, MD, Professor, University Hospital of Copenhagen Herlev and Gentofte
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Hospital in the Nursing Home
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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