Clinical trial NCT05527223: Integrated Care with GP Participation for Older Persons in the Ambulatory Care Hub: a Prospective Cohort 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Comprehensive Geriatric Assessment
Lead sponsor: University of Limerick
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 303
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of functional decline
timeFrame: 30-days
measure: Incidence of functional decline
timeFrame: 6-months
Secondary outcomes:
measure: Primary healthcare use (within and outside of ACH healthcare utilisation)
timeFrame: 30-days
measure: Primary healthcare use (within and outside of ACH healthcare utilisation)
timeFrame: 6-months
measure: Secondary healthcare use
timeFrame: 30-days
measure: Secondary healthcare use
timeFrame: 6-months
measure: Quality of integrated care from the perspective of participants
timeFrame: 30-days
measure: Health related quality of life (HRQOL)
timeFrame: 30-days
measure: Health related quality of life (HRQOL)
timeFrame: 6-months
measure: Mortality
timeFrame: 30-days
measure: Mortality
timeFrame: 6-months
measure: Nursing home admission
timeFrame: 30-days
measure: Nursing home admission
timeFrame: 6-months
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: School of Allied Health, University of Limerick.
state: Munster
Study officials:
affiliation: University of Limerick
name: Rose Galvin
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: World Health Organisation. Integrated Care for older people: Realigning primary health care to respond to population ageing. 2018.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: World Health Organization. World report on ageing and health: World Health Organization; 2015