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临床试验/NCT05706272
NCT05706272Unknown不适用

Secure And Focused Primary Care for Older pEople (SAFE) - A Proactive Trial

Linkoeping University2 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
4,000
试验地点
2
主要终点
Number of in-hospital days

研究概览

简要总结

The population worldwide is aging. The demographic change is challenging to health care organizations and highlights the need for effective preventive and proactive care models in primary care, especially for older people. This study, "Secure and focused primary care for older people" (SAFE), investigates the effectiveness of a new proactive care model based on comprehensive geriatric assessment (CGA) in primary care in a population with high risk of hospitalisation.

详细描述

Background and Aim

The number of old people is rising and in Sweden, approximately 20% of the population is older than 65 years. In 2050, the number of people 85 years and above, is expected to have doubled [1]. The demographic change is challenging to future healthcare systems [2]. The prevailing strategy for reducing the healthcare impact of an ageing population has been 'compression of morbidity', to extend the healthy period of life, and delay disability until a brief period at the end of life [3]. Thus, preventative and proactive primary care is central in meeting future challenges such as an aging population and highlights the need for effective preventive and proactive care models in primary care, especially for older people. This study, "Secure and focused primary care for older people" (SAFE), investigates the effectiveness of a new proactive care model in primary care in a population with high risk of hospitalisation.

Comprehensive geriatric assessment (CGA) is considered gold standard in evaluation and caring for old in-hospital patients [4]. CGA is described as a multidimensional, multidisciplinary and holistic evaluation of the health status of an older person, together with the formation of a care plan based on individual needs and preferences [4]. Data from outpatients in geriatric care has shown that CGA may delay the progression of frailty, but the study population was quite small [5].There is evidence that CGA can decrease the need of inpatient care and nursing home admissions. Some studies suggest that comprehensive care programs can be cost-effective. They also seem to be widely accepted and increase patient satisfaction [6,7]. However, results are conflicting and meta-analyses suffer from the lack of a universal definition of frailty and the great variation of interventions, outcome measures and scales to measure frailty. Still, both NICE guidelines and the ICOPE recommendations of the WHO include CGA for older people with frailty and/or multimorbidity [8].

In a previous study, "Proactive healthcare for frail elderly persons", a predictive statistical model that identified individuals, 75 years and above, with high risk for hospitalisation during the coming 12 months, was validated [9]. The effectiveness of CGA adapted to primary care using the new CGA tool: the Primary care Assessment Tool for Elderly (PASTEL), delivered to older adults with identified high risk for hospitalisation, was evaluated [10]. This pragmatic multicenter trial comprised nine intervention practices and ten matched control practices in the county council of Östergötland, Sweden, in 2017-2019. No specific intervention measures beyond the CGA assessment with PASTEL were described or analyzed in the study. Follow-up was part of ordinary clinical routine. Which specific interventions in primary care that really make a difference to reduce risk for hospitalisation and improve quality of life for old outpatients remains to be explored.

The main aim of the present study is to examine whether a proactive care model with comprehensive geriatric assessment (CGA) in primary care with additional long-term care coordination and increased patient participation, contributes to reduced inpatient care and/or increased quality of life among community-dwelling older people. The CGA used in this study will be based on the instrument "the Primary Care Assessment Tool for Elderly" (PASTEL).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 75 years or older
  • community dwelling (living in own home)
  • Top 15% of risk score calculation

排除标准

  • - Persons living in nursing homes

研究组 & 干预措施

Intervention primary care practices

Experimental

The participants in the intervention primary care practices arm will receive a holistic CGA using the PASTEL assessment tool. An "elderly team" including a doctor and nurse will work around the patient. The intervention includes increased care coordination.

干预措施: Comprehensive geriatric assessment (CGA) (Other)

结局指标

主要结局

Number of in-hospital days

时间窗: 24 months

Total number of days that a patient is admitted to hospital

次要结局

  • Number of persons living in nursing homes(24 months)
  • Number of health care visits(24 months)
  • Time to event (when moving to nursing home)(24 months)
  • Mortality(24 months)
  • Sense of safety and control(24 months)
  • Number of in-hospital episodes(24 months)
  • Health care costs(24 months)
  • Cost-effectiveness, cost/QALY(24 months)
  • Health related quality of life (HRQoL)(24 months)

研究者

发起方
Linkoeping University
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anna Segernas

PhD MD

Linkoeping University

研究点 (2)

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