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Secure and Focused Primary Care for Older pEople (SAFE)

Primary Purpose

Frailty

Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Comprehensive geriatric assessment (CGA)
Care as usual
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Frailty, Primary care, Geriatrics, Comprehensive geriatric assessment

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Jönköping
  • Region Östergötland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention primary care practices

Matched control primary care practices

Arm Description

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.

The participants in the matched control primary care practices arm will receive care as usual at the matched control primary care centers.

Outcomes

Primary Outcome Measures

Number of in-hospital days
Total number of days that a patient is admitted to hospital

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2023
Last Updated
October 3, 2023
Sponsor
Linkoeping University
Collaborators
Region Östergötland, Region Jönköping County
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1. Study Identification

Unique Protocol Identification Number
NCT05706272
Brief Title
Secure and Focused Primary Care for Older pEople
Acronym
SAFE
Official Title
Secure And Focused Primary Care for Older pEople (SAFE) - A Proactive Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Region Östergötland, Region Jönköping County

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
Frailty, Primary care, Geriatrics, Comprehensive geriatric assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will include 26 intervention primary care practices and 25 matched control practices.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention primary care practices
Arm Type
Experimental
Arm Description
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.
Arm Title
Matched control primary care practices
Arm Type
Active Comparator
Arm Description
The participants in the matched control primary care practices arm will receive care as usual at the matched control primary care centers.
Intervention Type
Other
Intervention Name(s)
Comprehensive geriatric assessment (CGA)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
The control group will receive care as usual at the matched control primary care centers
Primary Outcome Measure Information:
Title
Number of in-hospital days
Description
Total number of days that a patient is admitted to hospital
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of in-hospital episodes
Description
Number of times that a patient is admitted to hospital (regardless of length of stay)
Time Frame
24 months
Title
Number of health care visits
Description
Number of visits that a patient makes to a health care provider (hospital and primary care)
Time Frame
24 months
Title
Number of persons living in nursing homes
Description
Number of persons living in a nursing home
Time Frame
24 months
Title
Time to event (when moving to nursing home)
Description
The time when a person needs to move from own home to a nursing home
Time Frame
24 months
Title
Mortality
Description
All cause mortality
Time Frame
24 months
Title
Health care costs
Description
Total health care costs including hospital care and primary care
Time Frame
24 months
Title
Health related quality of life (HRQoL)
Description
HRQoL collected through the EQ-5D-5L
Time Frame
24 months
Title
Cost-effectiveness, cost/QALY
Description
Health economic calculation of the cost-effectiveness of the intervention including both health care costs and HRQoL data
Time Frame
24 months
Title
Sense of safety and control
Description
The patients sense of safety and control will be collected using the ASCOT instrument
Time Frame
24 months
Title
Health related quality of life (HRQoL)
Description
HRQoL collected through the RAND-36
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Region Jönköping
City
Jönköping
Country
Sweden
Facility Name
Region Östergötland
City
Linköping
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data may be made available upon request when the study is completed following the laws for sharing patient data.
Citations:
Citation
Socialstyrelsen, Vård om omsorg om äldre, 2020. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/ovrigt/2020-3-6603.pdf.
Results Reference
background
PubMed Identifier
30185958
Citation
Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.
Results Reference
background
PubMed Identifier
25639909
Citation
Seals DR, Justice JN, LaRocca TJ. Physiological geroscience: targeting function to increase healthspan and achieve optimal longevity. J Physiol. 2016 Apr 15;594(8):2001-24. doi: 10.1113/jphysiol.2014.282665. Epub 2015 Mar 11.
Results Reference
background
PubMed Identifier
29206906
Citation
Parker SG, McCue P, Phelps K, McCleod A, Arora S, Nockels K, Kennedy S, Roberts H, Conroy S. What is Comprehensive Geriatric Assessment (CGA)? An umbrella review. Age Ageing. 2018 Jan 1;47(1):149-155. doi: 10.1093/ageing/afx166.
Results Reference
background
PubMed Identifier
30039453
Citation
Mazya AL, Garvin P, Ekdahl AW. Outpatient comprehensive geriatric assessment: effects on frailty and mortality in old people with multimorbidity and high health care utilization. Aging Clin Exp Res. 2019 Apr;31(4):519-525. doi: 10.1007/s40520-018-1004-z. Epub 2018 Jul 23.
Results Reference
background
PubMed Identifier
27114104
Citation
Hopman P, de Bruin SR, Forjaz MJ, Rodriguez-Blazquez C, Tonnara G, Lemmens LC, Onder G, Baan CA, Rijken M. Effectiveness of comprehensive care programs for patients with multiple chronic conditions or frailty: A systematic literature review. Health Policy. 2016 Jul;120(7):818-32. doi: 10.1016/j.healthpol.2016.04.002. Epub 2016 Apr 11.
Results Reference
background
PubMed Identifier
28049616
Citation
Pilotto A, Cella A, Pilotto A, Daragjati J, Veronese N, Musacchio C, Mello AM, Logroscino G, Padovani A, Prete C, Panza F. Three Decades of Comprehensive Geriatric Assessment: Evidence Coming From Different Healthcare Settings and Specific Clinical Conditions. J Am Med Dir Assoc. 2017 Feb 1;18(2):192.e1-192.e11. doi: 10.1016/j.jamda.2016.11.004. Epub 2016 Dec 31.
Results Reference
background
PubMed Identifier
27683922
Citation
National Guideline Centre (UK). Multimorbidity: Assessment, Prioritisation and Management of Care for People with Commonly Occurring Multimorbidity. London: National Institute for Health and Care Excellence (NICE); 2016 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK385543/
Results Reference
background
PubMed Identifier
32143637
Citation
Marcusson J, Nord M, Dong HJ, Lyth J. Clinically useful prediction of hospital admissions in an older population. BMC Geriatr. 2020 Mar 6;20(1):95. doi: 10.1186/s12877-020-1475-6.
Results Reference
background
PubMed Identifier
33882862
Citation
Nord M, Lyth J, Alwin J, Marcusson J. Costs and effects of comprehensive geriatric assessment in primary care for older adults with high risk for hospitalisation. BMC Geriatr. 2021 Apr 21;21(1):263. doi: 10.1186/s12877-021-02166-1.
Results Reference
background

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Secure and Focused Primary Care for Older pEople

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