- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05527223
Integrated Care With GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort Study.
Integrated Care With GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort Study of Clinical and Process Outcomes.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christina Hayes
- Phone Number: 061234149
- Email: christina.hayes@ul.ie
Study Contact Backup
- Name: Rose Galvin
- Phone Number: 061234149
- Email: rose.galvin@ul.ie
Study Locations
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Munster
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Limerick, Munster, Ireland, V94 T9PX
- Recruiting
- School of Allied Health, University of Limerick.
-
Contact:
- Christina Hayes
- Phone Number: 061234149
- Email: christina.hayes@ul.ie
-
Contact:
- Rose Galvin
- Phone Number: 061234149
- Email: rose.galvin@ul.ie
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
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
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30-days
|
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.
|
6-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary healthcare use (within and outside of ACH healthcare utilisation)
Time Frame: 30-days
|
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.
|
30-days
|
Primary healthcare use (within and outside of ACH healthcare utilisation)
Time Frame: 6-months
|
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.
|
6-months
|
Secondary healthcare use
Time Frame: 30-days
|
Number of secondary healthcare services that participants were in receipt of including; Outpatient services, ED presentation and unplanned hospital admission.
|
30-days
|
Secondary healthcare use
Time Frame: 6-months
|
Number of secondary healthcare services that participants were in receipt of including; Outpatient services, ED presentation and unplanned hospital admission.
|
6-months
|
Quality of integrated care from the perspective of participants
Time Frame: 30-days
|
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.
|
30-days
|
Health related quality of life (HRQOL)
Time Frame: 30-days
|
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.
|
30-days
|
Health related quality of life (HRQOL)
Time Frame: 6-months
|
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.
|
6-months
|
Mortality
Time Frame: 30-days
|
The number of participants who died following their index visit at the ACH
|
30-days
|
Mortality
Time Frame: 6-months
|
The number of participants who died following their index visit at the ACH
|
6-months
|
Nursing home admission
Time Frame: 30-days
|
Number of participants who were admitted to a nursing home or residential care facility following their index visit to the ACH
|
30-days
|
Nursing home admission
Time Frame: 6-months
|
Number of participants who were admitted to a nursing home or residential care facility following their index visit to the ACH
|
6-months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rose Galvin, University of Limerick
Publications and helpful links
General Publications
- Glynn 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.
- 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.
- Mann 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.
- World 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.
- Roe 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.
- Briggs 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.
- World Health Organization. World report on ageing and health: World Health Organization; 2015
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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