Comparing Frailty Care Pathways in Rural Primary Care: a Feasibility Study

Primary Care General Practitioners (GPs) are always looking at ways to improve the care of older people and ways to prevent older people from losing their independence. Pro-active provision of support often involves lifestyle advice and is a potentially important aspect of that, as it supports older people before acute care is needed. It's preventative caring, rather than reactive caring. But, implementing pro-active care is hampered by the high current workload of acute care, the uncertainty of 'what works' and whether patients are responsive to pro-active care plans. This project will explore different ways of providing pro-active support to older people who could be at risk of losing their independence and requiring frequent acute care. The benefits of pro-active care are arguably the greatest in these individuals.

Study Overview

• Status: Withdrawn
• Conditions: Frailty
• Intervention / Treatment: Other: Frailty care pathway for older people in a rural primary care setting

Detailed Description

This is randomised control trial design with a cluster randomisation, whereby each cluster (a GP surgery) will have a different intervention. As it's a feasibility study, there will only be one cluster per intervention.

Participants will be recruited from 4 local primary care surgeries, and if participants take part, they will have 4 visits, and will be randomly allocation of an intervention arm, or a control arm receiving usual care.

At the start, the participant would have 2 visits of a maximum of 2 hours to the participant's local GP surgery to undergo a variety of tasks and assessments about the participant's well-being, health and physical functioning. That could lead to an 'action plan' that is implemented. The participant will have the 3rd visit after 3 months, and a final (fourth) visit after 12 months. During the 3rd and 4th visit the participant will repeat various tasks and assessments done in visit 1 and 2.

The project comprises different activities in the different GP surgeries. The project compares different approaches that each surgery takes. Generally, each surgery will assess relevant aspects that are associated with 'getting older' and provide support in the coming months. The specific approaches are based on the Comprehensive Geriatric Assessment, the World Health Organisation's recommendation and resources for the Integrated Care of Older People (ICOPE) model, the recommendations from the International Conference of Frailty and Sarcopenia Research (ICFSR) and the Functional Fitness test battery. All of these approaches would lead to an 'personal care plan' developed by the medical student, with actions that are specific to the participant's circumstances.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ceredigion
    • Aberystwyth, Ceredigion, United Kingdom, SY23 3FD
      • Aberystwyth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

The study focuses on community-dwelling frail older people (≥ 60 years). Each GP surgery will complete the electronic Frailty Index (eFI) to stratify older people based on their level of frailty (non-frail, mildly frail, and frail). Participants will be stratified into four strata,

• participants without complex care needs and with a relatively low frailty level (non-frail);
• participants with some chronic conditions that could put them at risk in the future (mild frailty)
• frail participants at risk of complex care needs (frailty)
• participants with complex care needs (severe frailty).

Inclusion Criteria:

• adults aged 60 years or older
• mild frailty or frailty based on the eFI,
• without severe cognitive impairment diagnoses,
• not currently taking part in other research or in the previous 6 months,
• willing to provide informed consent

Exclusion Criteria:

1. are terminally ill
2. have severe cognitive or psychological impairments,
3. have experienced a severe, disabling stroke within the previous 6 months
4. are unable to communicate in English.
5. are currently taking part in other research project, or was part of research in the previous 6 months.
6. have experienced a heart attack, or unstable angina within the previous 3 months.
7. already receive advice that includes exercise and diet by health professionals and were referred at discharge for condition-specific rehabilitation (e.g. pulmonary rehabilitation, stroke rehabilitation) within the previous 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comprehensive Geriatric Assessment (CGA); Participants in this arm will undertake a Comprehensive Geriatric Assessment, and will be implemented based on Comprehensive Geriatric Assessment Toolkit for Primary Care Practitioners from the British Geriatrics Society. A personalised action plan will be developed and implemented based on the CGA.	Other: Frailty care pathway for older people in a rural primary care setting; This intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions.
Experimental: Integrated Care for Older PEople (ICOPE); Participants in this arm will undertake the assessment recommended by the World Health Organisation, and will be implemented by the publicly available app. A personalised action plan will be developed and implemented based on the ICOPE.	Other: Frailty care pathway for older people in a rural primary care setting; This intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions.
Experimental: Identification and Management of frailty and sarcopenia; Participants in this arm will undertake the assessment recommended by the International Conference on Frailty and Sarcopenia Research Clinical Practice Guidelines for Identification and Management of physical frailty (ICFSR). A personalised action plan will be developed and implemented based on the ICFSR.	Other: Frailty care pathway for older people in a rural primary care setting; This intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions.
Experimental: Functional Fitness Battery (FFB); Participants in this arm will undertake a Functional Fitness Battery, comprising physical assessments on the intrinsic capacity, lifestyle and nutritional status	Other: Frailty care pathway for older people in a rural primary care setting; This intervention will take place in different primary care providers in a rural environment. Each provider will have one intervention and a no-intervention group, which will be part of the feasibility evaluation. The intervention will comprise a consultation with the participant, based on the different approaches described in the arm descriptions.
No Intervention: Usual Care; Participants in this arm will not receive an intervention, but the usual care provided by the primary care provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate (feasibility determination)	The recruitment rate reflects the recruitment method and number of eligible patients and general interest to take part.	6 months
Drop out rate (feasibility determination)	The drop out rate reflects the number of participants lost to follow up, response rates and adherence/compliance to the intervention.	12 months
Frequency of health care use	The number of hospital admissions and GP visits in the preceding 12 months	12 months
electronic Frailty Index	This score reflects the number of accumulated deficits	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	Quantified by the International Physical Activity Questionnaire (IPAQ)	12 months
Usual Walking Speed	The average speed of walking at a usual pace over a short distance of several meters	12 months
Grip Strength	Maximal strength assessed using a hand held dynamometer	12 months

Collaborators and Investigators

• Sponsor: Aberystwyth University
• Investigators: Principal Investigator: Marco Arkesteijn, PhD, Aberystwyth University

Publications and helpful links

General Publications

• Dent E, Morley JE, Cruz-Jentoft AJ, Woodhouse L, Rodriguez-Manas L, Fried LP, Woo J, Aprahamian I, Sanford A, Lundy J, Landi F, Beilby J, Martin FC, Bauer JM, Ferrucci L, Merchant RA, Dong B, Arai H, Hoogendijk EO, Won CW, Abbatecola A, Cederholm T, Strandberg T, Gutierrez Robledo LM, Flicker L, Bhasin S, Aubertin-Leheudre M, Bischoff-Ferrari HA, Guralnik JM, Muscedere J, Pahor M, Ruiz J, Negm AM, Reginster JY, Waters DL, Vellas B. Physical Frailty: ICFSR International Clinical Practice Guidelines for Identification and Management. J Nutr Health Aging. 2019;23(9):771-787. doi: 10.1007/s12603-019-1273-z.
• de Jong LD, Peters A, Hooper J, Chalmers N, Henderson C, Laventure RM, Skelton DA. The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study. JMIR Res Protoc. 2016 Jun 20;5(2):e108. doi: 10.2196/resprot.5682.

Helpful Links

• The CGA toolkit for primary care, used in one of the intervention arms
• The ICOPE app, used in one of the intervention arms

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: primary care; intervention; rural
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 16470 (Other Identifier: Bayer AG)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The project data will be made public via the Open Science Framework. This will include all IPD that underlie results in a publication
• IPD Sharing Time Frame: By december 2022, final data set will be made available comprising the primary and secondary outcome variables, potential other variables collected as part of the intervention arms.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No