FrailtyNCT05527223
Integrated Care with GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort Study.
An observational study of Frailty and Comprehensive Geriatric Assessment, run by University of Limerick at 1 site in Ireland.
Trial summary
Comprehensive Geriatric Assessment (CGA) demonstrates positive outcomes amoung community-dwelling older people living with frailty. However, there is currently no evidence of benefit for CGA with General Practitioner (GP) participation within the Irish Primary Care setting. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, Comprehensive Geriatric Assessment
- How many people
- 303 participants
- Where
- 1 siteIreland
- Study dates
- 2 Feb 2022to 30 Dec 2023
- Phase
- Observational
- 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
Study population: All older adults aged ≥75 years who are referred to the ACH by their GP between February 2022 and January 2023 (inclusive) will be considered eligible for participation in the study, if they meet the inclusion criteria.
Who may be able to join
- Referred to the ACH by their GP
- Score between 4 and 6 on the Rockwood Clinical Frailty Scale
- Reside within CHO 3 and the catchment area of the relevant ACH hub
- Have been assessed in-person by the referrer
- Has not had MDT input within the last three months
- And any one of the following criteria:
Show all 12Show fewer
- Fall within the last month unrelated to acute cardiac or neurological cause \& no previous falls assessment
- Increased dependency or increased carer burden in the last month
- A deterioration in swallow in the last month including symptoms of recurrent chest infections
- Weight loss
- Coughing when eating/drinking
- Self-modifying diet secondary to difficulties or experienced an adverse drug reaction within the last month excluding allergic reaction.
Who cannot join
- Patients will be excluded if they:
- Present with an acute neurological or cardiovascular event
- Are more appropriate to an alternative care pathway or service e.g. primary care or geriatric medicine clinic
- Present with injuries, unless the injury has already been appropriately managed,
- Are experiencing an acute medical illness requiring treatment in an acute hospital setting
- If care is being provided by other health care professionals at the time of referral and it is apparent that they are working to meet goals aligned with the current service
Show all 10Show fewer
- They require investigation or treatment not available in the relevant ICPOP hub (unless these investigations are already being arranged elsewhere)
- They have had MDT input in the last three months
- Have confirmed or suspected Covid-19 infection
- Or other exclusions at the discretion of the integrated care team based on clinical expertise and available resource.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
School of Allied Health, University of Limerick.
Limerick, Munster, V94 T9PX
About this study
Official title: Integrated Care with GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort Study of Clinical and Process Outcomes.
Comprehensive Geriatric Assessment (CGA) demonstrates positive outcomes amoung community-dwelling older people living with frailty. However, there is currently no evidence of benefit for CGA with General Practitioner (GP) participation within the Irish Primary Care setting. This study aims to explore the clinical and process outcomes of older adults living with frailty who are screened by and referred to one of the three Ambulatory Care Hub's in the primary care setting in the Mid-West of Ireland by their GP, where they undergo a CGA .
Read the detailed description
The growth of ageing population poses significant difficulties in the delivery of healthcare to older adults. As people age, they experience a decline in their intrinsic capacities which leads to an increasing prevalence of multi-morbidity which ultimately leads to older adults at increased risk of requiring emergency care and increased multidisciplinary health needs.
With functional decline and deterioration in an older persons' ability to self-care being a common consequence of hospitalisation, older people are placed at higher risk of requiring increased care needs after discharge from acute care and transfer between care settings proves a challenge for the provision of seamless quality care.
The World Health Organisation recommends health and social care professionals intervening at an early stage of this ageing process in order to prevent or delay the process of becoming frail through delivering effective interventions that are targeted at functional decline. Internationally, there is recognition for health and social care systems to reorient towards longitudinal, preventive, coordinated and integrated care models, reflecting the growth in multi-morbidity and the needs of older people's complex health and social care requirements. The World Health Organisation acknowledges this shift in healthcare delivery and launched the 'WHO Guidelines on Integrated Care for Older People' programme where it highlighted the need to develop and implement comprehensive community-based approaches at the primary healthcare level in the context of a needs assessment and integrated care plan.
CGA is an interdisciplinary diagnostic process which includes an assessment and holistic management plan that is based on the individual needs of the older person. As many older adults' first point of contact with the health service is through primary care, General Practitioners (GPs) play a crucial role in the coordination of the older person's care.
Frailty screening by the GP and comprehensive geriatric assessment within the primary care setting has demonstrated significant positive health outcomes in community-dwelling older people, demonstrating reduced rates of hospitalisation, reduced hospital re-admissions, reduced GP visits and an increase in social activities.
A primary care based multidisciplinary team aim to improve the delivery of care and clinical and process outcomes for community-dwelling older people through the delivery of CGA in the Ambulatory Care Hub (ACH). An ACH is a clinical site within the primary care setting, with access to diagnostics, specialised services and specialist care in order to support older people to live in their own homes for as long as possible.
This study aims to explore the clinical and process outcomes of older adults living with frailty who are screened by and referred to one of the three Ambulatory Care Hub's in the Mid-West of Ireland by their GP.
- Conditions
- Frailty, Comprehensive Geriatric Assessment
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of functional decline
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
Measured: 30-days
Incidence of functional decline
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
Measured: 6-months
Secondary outcomes (11)
Primary healthcare use (within and outside of ACH healthcare utilisation)
Number of services that participants were in receipt of following index visit at the ACH including; GP visits, Public Health Nurse visits, Health and Social Care Professional use, formal homecare support. This will be categorised by healthcare use linked to the ACH and outside of the ACH.
Measured: 30-days
Primary healthcare use (within and outside of ACH healthcare utilisation)
Number of services that participants were in receipt of following index visit at the ACH including; GP visits, Public Health Nurse visits, Health and Social Care Professional use, formal homecare support. This will be categorised by healthcare use linked to the ACH and outside of the ACH.
Measured: 6-months
Secondary healthcare use
Number of secondary healthcare services that participants were in receipt of including; Outpatient services, ED presentation and unplanned hospital admission.
Measured: 30-days
Secondary healthcare use
Number of secondary healthcare services that participants were in receipt of including; Outpatient services, ED presentation and unplanned hospital admission.
Measured: 6-months
Quality of integrated care from the perspective of participants
Participants evaluate the quality of integrated care across a number of domains using the Patient Assessment of Integrated Elderly Care Questionnaire. The sum of all subscales may range from 0-100, where a higher score reflects better perceived quality of care.
Measured: 30-days
Health related quality of life (HRQOL)
Participants will rate their HRQOL using the EuroQoL-5D-5L where the sum of 5 subscales may range from 5-25 where 5 points indicates the lowest possible HRQOL and 25 indicates the highest. The participant must also rate their health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' on a scale of 0-100.
Measured: 30-days
Health related quality of life (HRQOL)
Participants will rate their HRQOL using the EuroQoL-5D-5L where the sum of 5 subscales may range from 5-25 where 5 points indicates the lowest possible HRQOL and 25 indicates the highest. The participant must also rate their health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' on a scale of 0-100.
Measured: 6-months
Mortality
The number of participants who died following their index visit at the ACH
Measured: 30-days
Mortality
The number of participants who died following their index visit at the ACH
Measured: 6-months
Nursing home admission
Number of participants who were admitted to a nursing home or residential care facility following their index visit to the ACH
Measured: 30-days
Nursing home admission
Number of participants who were admitted to a nursing home or residential care facility following their index visit to the ACH
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start2 Feb 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rose Galvin, Study director, University of Limerick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527223
- Sponsor's protocol ID
- 116/2021
- Status last verified
- Jan 2025
- First submitted
- 11 Aug 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liljas AEM, Brattstrom F, Burstrom B, Schon P, Agerholm J. Impact of Integrated Care on Patient-Related Outcomes Among Older People - A Systematic Review. Int J Integr Care. 2019 Jul 24;19(3):6. doi: 10.5334/ijic.4632.
PubMed 31367205Mann J, Thompson F, McDermott R, Esterman A, Strivens E. Impact of an integrated community-based model of care for older people with complex conditions on hospital emergency presentations and admissions: a step-wedged cluster randomized trial. BMC Health Serv Res. 2021 Jul 16;21(1):701. doi: 10.1186/s12913-021-06668-x.
PubMed 34271945World Health Organisation. Integrated Care for older people: Realigning primary health care to respond to population ageing. 2018.
Everink IHJ, van Haastregt JCM, Tan FES, Schols JMGA, Kempen GIJM. The effectiveness of an integrated care pathway in geriatric rehabilitation among older patients with complex health problems and their informal caregivers: a prospective cohort study. BMC Geriatr. 2018 Nov 16;18(1):285. doi: 10.1186/s12877-018-0971-4.
PubMed 30445923Roe L, Normand C, Wren MA, Browne J, O'Halloran AM. The impact of frailty on healthcare utilisation in Ireland: evidence from the Irish longitudinal study on ageing. BMC Geriatr. 2017 Sep 5;17(1):203. doi: 10.1186/s12877-017-0579-0.
PubMed 28874140Briggs R, McDonough A, Ellis G, Bennett K, O'Neill D, Robinson D. Comprehensive Geriatric Assessment for community-dwelling, high-risk, frail, older people. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012705. doi: 10.1002/14651858.CD012705.pub2.
PubMed 35521829Glynn LG, Valderas JM, Healy P, Burke E, Newell J, Gillespie P, Murphy AW. The prevalence of multimorbidity in primary care and its effect on health care utilization and cost. Fam Pract. 2011 Oct;28(5):516-23. doi: 10.1093/fampra/cmr013. Epub 2011 Mar 24.
PubMed 21436204World Health Organization. World report on ageing and health: World Health Organization; 2015
Hayes C, Whiston A, Fitzgerald C, Devlin C, Condon B, Manning M, Leahy A, Robinson K, Galvin R. Community Specialist Teams for Older Persons (CST-OP) at risk of, or living with frailty in Ireland: a prospective cohort study of a new model of integrated care for community dwelling older adults. BMC Prim Care. 2025 Jun 5;26(1):193. doi: 10.1186/s12875-025-02895-x.
PubMed 40474059
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Care with GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort Study of Clinical and Process Outcomes.
- ClinicalTrials.gov ID
- NCT05527223
- Acronym / sponsor ID
- 116/2021
- Conditions
- Frailty, Comprehensive Geriatric Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 2 Sep 2022 (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.
Comprehensive Geriatric Assessment (CGA) demonstrates positive outcomes amoung community-dwelling older people living with frailty. However, there is currently no evidence of benefit for CGA with General Practitioner (GP) participation within the Irish Primary Care setting. This study aims to explore the clinical and process outcomes of older adults living with frailty who are screened by and referred to one of the three Ambulatory Care Hub's in the primary care setting in the Mid-West of Ireland by their GP, where they undergo a CGA .
Detailed description
The growth of ageing population poses significant difficulties in the delivery of healthcare to older adults. As people age, they experience a decline in their intrinsic capacities which leads to an increasing prevalence of multi-morbidity which ultimately leads to older adults at increased risk of requiring emergency care and increased multidisciplinary health needs.
With functional decline and deterioration in an older persons' ability to self-care being a common consequence of hospitalisation, older people are placed at higher risk of requiring increased care needs after discharge from acute care and transfer between care settings proves a challenge for the provision of seamless quality care.
The World Health Organisation recommends health and social care professionals intervening at an early stage of this ageing process in order to prevent or delay the process of becoming frail through delivering effective interventions that are targeted at functional decline. Internationally, there is recognition for health and social care systems to reorient towards longitudinal, preventive, coordinated and integrated care models, reflecting the growth in multi-morbidity and the needs of older people's complex health and social care requirements. The World Health Organisation acknowledges this shift in healthcare delivery and launched the 'WHO Guidelines on Integrated Care for Older People' programme where it highlighted the need to develop and implement comprehensive community-based approaches at the primary healthcare level in the context of a needs assessment and integrated care plan.
CGA is an interdisciplinary diagnostic process which includes an assessment and holistic management plan that is based on the individual needs of the older person. As many older adults' first point of contact with the health service is through primary care, General Practitioners (GPs) play a crucial role in the coordination of the older person's care.
Frailty screening by the GP and comprehensive geriatric assessment within the primary care setting has demonstrated significant positive health outcomes in community-dwelling older people, demonstrating reduced rates of hospitalisation, reduced hospital re-admissions, reduced GP visits and an increase in social activities.
A primary care based multidisciplinary team aim to improve the delivery of care and clinical and process outcomes for community-dwelling older people through the delivery of CGA in the Ambulatory Care Hub (ACH). An ACH is a clinical site within the primary care setting, with access to diagnostics, specialised services and specialist care in order to support older people to live in their own homes for as long as possible.
This study aims to explore the clinical and process outcomes of older adults living with frailty who are screened by and referred to one of the three Ambulatory Care Hub's in the Mid-West of Ireland by their GP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All older adults aged ≥75 years who are referred to the ACH by their GP between February 2022 and January 2023 (inclusive) will be considered eligible for participation in the study, if they meet the inclusion criteria.
Key inclusion criteria (12 listed)
- Referred to the ACH by their GP
- Score between 4 and 6 on the Rockwood Clinical Frailty Scale
- Reside within CHO 3 and the catchment area of the relevant ACH hub
- Have been assessed in-person by the referrer
- Has not had MDT input within the last three months
Key exclusion criteria (10 listed)
- Present with an acute neurological or cardiovascular event
- Are more appropriate to an alternative care pathway or service e.g. primary care or geriatric medicine clinic
- Present with injuries, unless the injury has already been appropriately managed,
- Are experiencing an acute medical illness requiring treatment in an acute hospital setting
- If care is being provided by other health care professionals at the time of referral and it is apparent that they are working to meet goals aligned with the current service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of functional decline
Time frame: 30-days
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
Incidence of functional decline
Time frame: 6-months
The number of participants who experience functional decline or do not as measured by the Barthel Index (BI). Functional decline is defined as a net decrease in the number of activities of daily living performed independently as measured by the self-reported BI. The sum of all of the 10 subscales of the BI ranges from 0-20 points where a higher score indicates increased independence.
11 secondary outcomes
Primary healthcare use (within and outside of ACH healthcare utilisation)
Time frame: 30-days
Primary healthcare use (within and outside of ACH healthcare utilisation)
Time frame: 6-months
Secondary healthcare use
Time frame: 30-days
Secondary healthcare use
Time frame: 6-months
Quality of integrated care from the perspective of participants
Time frame: 30-days
Health related quality of life (HRQOL)
Time frame: 30-days
Health related quality of life (HRQOL)
Time frame: 6-months
Mortality
Time frame: 30-days
Mortality
Time frame: 6-months
Nursing home admission
Time frame: 30-days
Nursing home admission
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Background: PubMed 31367205Liljas AEM, Brattstrom F, Burstrom B, Schon P, Agerholm J. Impact of Integrated Care on Patient-Related Outcomes Among Older People - A Systematic Review. Int J Integr Care. 2019 Jul 24;19(3):6. doi: 10.5334/ijic.4632.
- Background: PubMed 34271945Mann J, Thompson F, McDermott R, Esterman A, Strivens E. Impact of an integrated community-based model of care for older people with complex conditions on hospital emergency presentations and admissions: a step-wedged cluster randomized trial. BMC Health Serv Res. 2021 Jul 16;21(1):701. doi: 10.1186/s12913-021-06668-x.
- BackgroundWorld Health Organisation. Integrated Care for older people: Realigning primary health care to respond to population ageing. 2018.
- Background: PubMed 30445923Everink IHJ, van Haastregt JCM, Tan FES, Schols JMGA, Kempen GIJM. The effectiveness of an integrated care pathway in geriatric rehabilitation among older patients with complex health problems and their informal caregivers: a prospective cohort study. BMC Geriatr. 2018 Nov 16;18(1):285. doi: 10.1186/s12877-018-0971-4.
- Background: PubMed 28874140Roe L, Normand C, Wren MA, Browne J, O'Halloran AM. The impact of frailty on healthcare utilisation in Ireland: evidence from the Irish longitudinal study on ageing. BMC Geriatr. 2017 Sep 5;17(1):203. doi: 10.1186/s12877-017-0579-0.
- Background: PubMed 35521829Briggs R, McDonough A, Ellis G, Bennett K, O'Neill D, Robinson D. Comprehensive Geriatric Assessment for community-dwelling, high-risk, frail, older people. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012705. doi: 10.1002/14651858.CD012705.pub2.
- Background: PubMed 21436204Glynn LG, Valderas JM, Healy P, Burke E, Newell J, Gillespie P, Murphy AW. The prevalence of multimorbidity in primary care and its effect on health care utilization and cost. Fam Pract. 2011 Oct;28(5):516-23. doi: 10.1093/fampra/cmr013. Epub 2011 Mar 24.
- BackgroundWorld Health Organization. World report on ageing and health: World Health Organization; 2015
- Derived from this study: PubMed 40474059Hayes C, Whiston A, Fitzgerald C, Devlin C, Condon B, Manning M, Leahy A, Robinson K, Galvin R. Community Specialist Teams for Older Persons (CST-OP) at risk of, or living with frailty in Ireland: a prospective cohort study of a new model of integrated care for community dwelling older adults. BMC Prim Care. 2025 Jun 5;26(1):193. doi: 10.1186/s12875-025-02895-x.
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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.
Rose Galvin study director
University of Limerick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Comprehensive Geriatric Assessment, run by University of Limerick at 1 site in Ireland.
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 12 inclusion and 10 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: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of functional decline (time frame: 30-days). The study lists 2 primary outcomes in all. 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 NCT05527223, which also lists 9 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 10 Feb 2025.