跳至主要内容
临床试验/NCT07359521
NCT07359521进行中(未招募)不适用

Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospital (RATHER-NH): Study Protocol for a Pilot Cluster Randomized Controlled Trial.

Vrije Universiteit Brussel6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
12
试验地点
6
主要终点
Outcomes on healthcare use per 100 person-months

研究概览

简要总结

Hospital admissions can have a negative impact on the physical and emotional health of nursing home residents. Although evidence-based interventions have been developed to reduce hospitalisations, the evidence regarding their effectiveness is inconclusive and challenges have been reported in implementing these interventions within the nursing home context. Hence, this study aimed to implement and evaluate a complex intervention to reduce avoidable transitions between nursing home and hospital (RATHER-NH).

详细描述

The researchers will conduct a pilot cluster randomized controlled trial (RCT) of the RATHER-NH intervention with an embedded process evaluation. This study has two specific objectives: 1) to evaluate the implementation of the RATHER-NH intervention, the perceived impact and underlying mechanisms of impact, and the contextual factors influencing implementation and impact; and 2) To assess the feasibility of the trial methods and procedures, and the potential primary and secondary outcome measures for a future full-scale RCT.

The study will be conducted in twelve nursing homes in Flanders, of which six will be randomly assigned to the intervention group and six to the control group.

The researchers will use the MRC guidance on complex intervention development and evaluation combined with the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to guide the implementation and evaluation of RATHER-NH.

Based on the results of the qualitative study with nursing home residents, family carers and professional stakeholders, and on existing scientific literature, a first version of a logic model was developed, which illustrates the different determinants and mechanisms that influence the anticipated outcomes and impact of the RATHER-NH intervention. The logic model was used to select relevant intervention tools from the INTERACT Quality Improvement Program and our own self-developed tool concerning a GP communication tool:

A) Stop and Watch Early Warning Tool This is a checklist that marks the most relevant changes in the physical and behavioural condition of a nursing home resident that eventually may lead to a potentially avoidable hospitalisation.

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
是

入选标准

  • •for nursing homes:
  • •A capacity of at least 60 beds
  • •Active engagement for the study from nursing home management, head nurses and the coordinating & advisory physician, meaning:
  • •The nursing home manager, head nurses and the coordinating & advisory physician agree that the implementation of the RATHER-NH intervention is a priority for their facility.
  • •The nursing home manager agrees to provide time for the nursing home staff members to participate in activities related to the implementation of RATHER-NH such as attending information sessions, training workshops, and feedback moments.
  • •The nursing home manager is willing to allocate time to at least two nursing home staff members (each approximately 0.1 FTE for the study duration) to act as local project champions and to at least four other staff members (type of staff to be decided with the nursing home manager) to form a local action team to support the implementation and evaluation of RATHER-NH.

排除标准

  • •for nursing homes:
  • •Already participated in another project designed to reduce potentially avoidable hospitalisations.
  • •Already taking part in another major quality improvement initiative or study.
  • •A large reorganisation or change in staff is taking place or is planned during the study period.

研究组 & 干预措施

Intervention group

Experimental

Nursing homes in the intervention group will implement tools from the RATHER-NH intervention toolkit using a tailored implementation strategy over a period of approximately 9 months.

干预措施: RATHER-NH Toolkit (Other)

Control group

No Intervention

Care as usual

结局指标

主要结局

Outcomes on healthcare use per 100 person-months

时间窗: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.

Rate of hospitalisations per 100 person-months, rate of out-of-hours GP contacts per 100 person-months, rate of emergency department visits (without hospitalisation) per 100 person-months.

Outcomes on healthcare use per hospitalisation

时间窗: Retrospective baseline measurement of 3 months, during the intervention (period of 9 months) untill 3 months post-intervention for the post-interventions measurement.

Length of hospital stay, cause of hospitalisation, hospitalisation in the last month of life (in case of death) and place of death

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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