FrailtySAFENCT05706272
Secure and Focused Primary Care for Older pEople
A study testing Comprehensive geriatric assessment (CGA) and Care as usual in people with Frailty, run by Linkoeping University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Comprehensive geriatric assessment (CGA) and Care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Feb 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 75 years or older
- community dwelling (living in own home)
- Top 15% of risk score calculation
Who cannot join
- Persons living in nursing homes
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Secure And Focused Primary Care for Older pEople (SAFE) - A Proactive Trial
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Comprehensive geriatric assessment (CGA), Care as usual
- Keywords
- Frailty, Primary care, Geriatrics, Comprehensive geriatric assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Care as usualOther
The control group will receive care as usual at the matched control primary care centers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of in-hospital days
Total number of days that a patient is admitted to hospital
Measured: 24 months
Secondary outcomes (10)
Number of in-hospital episodes
Number of times that a patient is admitted to hospital (regardless of length of stay)
Measured: 24 months
Number of health care visits
Number of visits that a patient makes to a health care provider (hospital and primary care)
Measured: 24 months
Number of persons living in nursing homes
Number of persons living in a nursing home
Measured: 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
Measured: 24 months
Mortality
All cause mortality
Measured: 24 months
Health care costs
Total health care costs including hospital care and primary care
Measured: 24 months
Health related quality of life (HRQoL)
HRQoL collected through the EQ-5D-5L
Measured: 24 months
Cost-effectiveness, cost/QALY
Health economic calculation of the cost-effectiveness of the intervention including both health care costs and HRQoL data
Measured: 24 months
Sense of safety and control
The patients sense of safety and control will be collected using the ASCOT instrument
Measured: 24 months
Health related quality of life (HRQoL)
HRQoL collected through the RAND-36
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will include 26 intervention primary care practices and 25 matched control practices.
- Masking
- None (open label)
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Region Östergötland, Region Jönköping County
- Responsible party
- Principal investigator, Anna Segernas, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706272
- Sponsor's protocol ID
- 2022-03388-01
- Acronym
- SAFE
- Status last verified
- Mar 2024
- First submitted
- 9 Jan 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be made available upon request when the study is completed following the laws for sharing patient data.
Publications
Socialstyrelsen, Vård om omsorg om äldre, 2020. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/ovrigt/2020-3-6603.pdf.
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.
PubMed 30185958Seals 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.
PubMed 25639909Parker 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.
PubMed 29206906Mazya 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.
PubMed 30039453Hopman 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.
PubMed 27114104Pilotto 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.
PubMed 28049616National 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/
PubMed 27683922Marcusson 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.
PubMed 32143637Nord 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.
PubMed 33882862
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secure And Focused Primary Care for Older pEople (SAFE) - A Proactive Trial
- ClinicalTrials.gov ID
- NCT05706272
- Acronym / sponsor ID
- SAFE / 2022-03388-01
- Conditions
- Frailty
- Keywords
- Frailty, Primary care, Geriatrics, Comprehensive geriatric assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Region Östergötland, Region Jönköping County
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will include 26 intervention primary care practices and 25 matched control practices.
| Arm | Type | Receives |
|---|---|---|
| Intervention primary care practices | Experimental | Other: Comprehensive geriatric assessment (CGA)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. |
| Matched control primary care practices | Active comparator | Other: Care as usualThe participants in the matched control primary care practices arm will receive care as usual at the matched control primary care centers. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 75 years or older
- community dwelling (living in own home)
- Top 15% of risk score calculation
Key exclusion criteria (1 listed)
- Persons living in nursing homes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive geriatric assessment (CGA)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. | Other | Intervention primary care practices |
| Care as usualThe control group will receive care as usual at the matched control primary care centers | Other | Matched control primary care practices |
Primary outcome
Number of in-hospital days
Time frame: 24 months
Total number of days that a patient is admitted to hospital
10 secondary outcomes
Number of in-hospital episodes
Time frame: 24 months
Number of health care visits
Time frame: 24 months
Number of persons living in nursing homes
Time frame: 24 months
Time to event (when moving to nursing home)
Time frame: 24 months
Mortality
Time frame: 24 months
Health care costs
Time frame: 24 months
Health related quality of life (HRQoL)
Time frame: 24 months
Cost-effectiveness, cost/QALY
Time frame: 24 months
Sense of safety and control
Time frame: 24 months
Health related quality of life (HRQoL)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- BackgroundSocialstyrelsen, Vård om omsorg om äldre, 2020. https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/ovrigt/2020-3-6603.pdf.
- Background: PubMed 30185958Partridge 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.
- Background: PubMed 25639909Seals 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.
- Background: PubMed 29206906Parker 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.
- Background: PubMed 30039453Mazya 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.
- Background: PubMed 27114104Hopman 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.
- Background: PubMed 28049616Pilotto 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.
- Background: PubMed 27683922National 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/
- Background: PubMed 32143637Marcusson 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.
- Background: PubMed 33882862Nord 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.
- Individual participant dataSharing planned: Undecided. Data may be made available upon request when the study is completed following the laws for sharing patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive geriatric assessment (CGA) and Care as usual in people with Frailty, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of in-hospital days (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706272, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.