Secure and Focused Primary Care for Older pEople

NCT05706272 | Active Not Recruiting

• 1 other identifier: 2022-03388-01
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty

Keywords

Frailty; Primary care; Geriatrics; Comprehensive geriatric assessment

Outcome Measures

Primary Outcomes (1)

• Number of in-hospital days

  Total number of days that a patient is admitted to hospital

  24 months

Secondary Outcomes (10)

• Number of in-hospital episodes

  24 months

• Number of health care visits

  24 months

• Number of persons living in nursing homes

  24 months

• Time to event (when moving to nursing home)

  24 months

• Mortality

  24 months

Study Arms (2)

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.

Other: Comprehensive geriatric assessment (CGA)

Matched control primary care practices

ACTIVE COMPARATOR

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

Interventions

Comprehensive geriatric assessment (CGA) OTHER

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 primary care practices

Care as usual OTHER

The control group will receive care as usual at the matched control primary care centers

Matched control primary care practices

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- Persons living in nursing homes

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator
• Region Jönköping County: collaborator

Study Sites (2)

Region Jönköping

Jönköping, Sweden

Location

Region Östergötland

Linköping, Sweden

Location

Related Publications (10)

• Socialstyrelsen, Vård om omsorg om äldre, 2020. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/ovrigt/2020-3-6603.pdf.

  BACKGROUND

• 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.

  PMID: 30185958 BACKGROUND

• 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.

  PMID: 25639909 BACKGROUND

• 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.

  PMID: 29206906 BACKGROUND

• 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.

  PMID: 30039453 BACKGROUND

• 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.

  PMID: 27114104 BACKGROUND

• 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.

  PMID: 28049616 BACKGROUND

• 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/

  PMID: 27683922 BACKGROUND

• 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.

  PMID: 32143637 BACKGROUND

• 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.

  PMID: 33882862 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Model Details: The study will include 26 intervention primary care practices and 25 matched control practices.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 31, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

SE (2)