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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 9,000
- 试验地点
- 4
- 主要终点
- Time to first event
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Assisted living facilities, intermediate/temporary care units, rehabilitation units, hospices, or other non-nursing-home setting.
- •Nursing homes located on the island of Bornholm
研究组 & 干预措施
Home-based assessment and treatment
The intervention group
干预措施: Home-based Clinical Assessment and Treatment (Other)
Standard care
The control group
结局指标
主要结局
Time to first event
时间窗: 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.
All-cause mortality
时间窗: 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.
次要结局
- Initial Disposition After Assessment by the Municipal Acute Care Team(At completion of the index assessment, up to 6 hours.)
- Number of emergency contacts (both groups)(From date of randomization until the end of follow-up, up to 48 weeks.)
- Total healthcare cost per nursing home resident(From date of randomization until the end of follow-up, up to 48 weeks.)
- Proportion of in-hospital deaths(From date of randomization until date of death from any cause, up to 7 months)
- Proportion of end-of-life hospitalizations(From date of randomization until date of death from any cause, up to 7 months)
研究者
Josephine Lund Nielsen
Principal Investigator
Copenhagen University Hospital at Herlev