Secure and Focused Primary Care for Older pEople

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Design and Method This is a prospective, multi-center trial that will be carried out in two regions in Sweden (Östergötland and Jönköping). The study will include 26 intervention primary care practices and 25 matched control primary care practices. Data will be collected at baseline, at one year follow-up (12 months) and at two year follow-up (24 months). Participants will be identified through a statistical prediction model based on age, health care use and diagnostics data covering the previous year. A risk score for future morbidity and health care need will be calculated and the participants with the highest risk scores (top 15%) will be invited to participate in the study.

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

Conditions
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Frailty

Intervention / Treatment
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* Other: Comprehensive geriatric assessment (CGA)
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 75 years or older community dwelling (living in own home) Top 15% of risk score calculation Exclusion Criteria: - Persons living in nursing homes

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will include 26 intervention primary care practices and 25 matched control practices.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention primary care practices<br>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. | Other: Comprehensive geriatric assessment (CGA)<br>* The intervention includes a holistic comprehensive geriatric assessment using the PASTEL assessment tool that includes medical, psychiatric, functional and social aspects. Physical tests will include function, risk of falling, hand muscle strength, Timed up and Go (TUG), chair-stand test, blood pressure, saturation and BMI. A proactive person centered care plan will be established based on identified needs and the patients own priorities. A nurse will coordinate the care in the elderly team at the intervention practice with access to rehabilitation staff such as physiotherapist and occupational therapist. Follow-ups at the primary care practices will be carried out in accordance with the study plan. To strengthen care coordination, contact will be taken with other health care providers before the follow-ups.<br>|
| Active Comparator: Matched control primary care practices<br>The participants in the matched control primary care practices arm will receive care as usual at the matched control primary care centers. | Other: Care as usual<br>* The control group will receive care as usual at the matched control primary care centers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of in-hospital days | Total number of days that a patient is admitted to hospital | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of in-hospital episodes | Number of times that a patient is admitted to hospital (regardless of length of stay) | 24 months | 
| Number of health care visits | Number of visits that a patient makes to a health care provider (hospital and primary care) | 24 months | 
| Number of persons living in nursing homes | Number of persons living in a nursing home | 24 months | 
| Time to event (when moving to nursing home) | The time when a person needs to move from own home to a nursing home | 24 months | 
| Mortality | All cause mortality | 24 months | 
| Health care costs | Total health care costs including hospital care and primary care | 24 months | 
| Health related quality of life (HRQoL) | HRQoL collected through the EQ-5D-5L | 24 months | 
| Cost-effectiveness, cost/QALY | Health economic calculation of the cost-effectiveness of the intervention including both health care costs and HRQoL data | 24 months | 
| Sense of safety and control | The patients sense of safety and control will be collected using the ASCOT instrument | 24 months | 
| Health related quality of life (HRQoL) | HRQoL collected through the RAND-36 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Primary care, Geriatrics, Comprehensive geriatric assessment