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临床试验/NCT04113174
NCT04113174Unknown不适用

Development and Evaluation of the Electronic Frailty Index+ (eFI+) Tool: Integrated Prognostic-decision Modelling to Target Interventions for Older People With Moderate or Severe Frailty

University of Leeds0 个研究点目标入组 1,000,000 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,000,000
主要终点
Number of participants admitted to nursing homes

研究概览

简要总结

Research questions

i) How should electronic frailty index (eFI) components be combined with additional routine primary care data to develop prognostic models for predicting key outcomes of requirement for home care, falls/fractures, nursing home admission and mortality in older people with moderate or severe frailty?

ii) Can model predictive performance be improved through addition of data from measures that are practical for primary care use, but not available in routine data?

iii) How should risk predictions from the prognostic models be translated into a decision analytic model (DAM) to guide clinical management?

iv) What is the potential cost-effectiveness of implementing interventions targeted at subgroups of older people with frailty in routine NHS care?

Background

Lead applicant Clegg led the eFI development, validation and national implementation. This has been translated into major UK health policy change through inclusion in the 2017/18 GP contract, which supports frailty stratification using the eFI, and UK National Health Service Long Term Plan.

Aim

To develop and evaluate the eFI+, a prognostic tool supplementing the original eFI including 4 integrated prognostic-decision models. The eFI+ will stratify older people with moderate or severe frailty into subgroups most likely to benefit from key interventions (community rehabilitation; falls prevention; comprehensive geriatric assessment; advance care planning).

Methods

Design

Prognostic model development, internal validation and external validation using large datasets (ResearchOne, SAIL databank, Leeds Data Model) and cohort study data (CARE75+), with linked DAM and health economic analysis.

Population

Patients ≥65 with moderate or severe frailty, defined by the existing eFI.

Key outcomes

12-month outcomes for prognostic models:

  • New/increased home care package
  • Emergency Department (ED) attendance/hospitalisation with fall/fracture
  • Nursing home admission
  • All-cause mortality

Statistical methods

i) Prognostic modelling

The investigators will build 4 separate prognostic models for our 4 key outcomes by combining the eFI with additional individual-level routine data, informed by reviews to identify prognostic factors. Each model will be developed and internally validated in one large dataset, to adjust for potential overfitting, with subsequent external validation of predictive performance in a second large dataset.

Separately, the investigators will use CARE75+ (n≈1,200) to investigate additional predictive value of clinical measures practical for primary care (e.g. gait speed, activities of daily living, loneliness).

ii) Decision analytic model (DAM)

The investigators will translate the prognostic models into a framework to support clinical decision-making, in co-production with stakeholders/PPI. The investigators will integrate prognostic models with effect size estimates from systematic reviews/meta-analyses to identify relevant thresholds of predicted risk, above which implementation of our key interventions would be warranted.

iii) Health economic evaluation

12-month and long-term cost effectiveness models will be developed, informed by the DAM.

详细描述

Health technologies being assessed

The eFI+ will be developed using components of the original eFI, supplemented with additional routine primary care EHR data, and guidance on the added benefits of implementing simple clinical measures in routine primary care practice. The eFI+ will be suitable for rapid implementation in UK primary care EHR systems, building on existing close links with system suppliers (SystmOne/EMISWeb/Vision/Microtest).

The investigators will develop, then internally and externally validate the eFI+ using the Secure Anonymised Information Linkage (SAIL) databank, the ResearchOne database, and the Leeds Data Model (LDM).

In addition, the investigators will analyse Community Ageing Research 75+ (CARE75+) cohort study data (CI Clegg, n≈1,200) as the only national cohort study to include eFI scores, to investigate how simple measures that can be assessed in primary care, but are not available in routine EHR data (e.g. gait speed, timed-up-and-go test; activities of daily living; loneliness) may improve prediction.

Study design

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥65 years
  • Moderate frailty (eFI score 0.24 to 0.36) or severe frailty (eFI score >0.36)
  • Registered with a ResearchOne, SAIL or LDM practice on 1st April 2018
  • CARE75+ participants with moderate frailty (eFI score 0.24 to 0.36) or severe frailty (eFI score >0.36)

排除标准

  • Age <65 years
  • Fit/mild frailty

结局指标

主要结局

Number of participants admitted to nursing homes

时间窗: 12 months

Incidence of new admission to a nursing home, identified by new nursing home residence in the routine dataset, based on address data

All-cause mortality

时间窗: 12 months

Incidence of all-cause mortality, defined using Office for National Statistics death data, or coded evidence of death in the routine dataset

Number of participants requiring new/increased home care package

时间窗: 12 months

Incidence of new or increased home care services, identified by coded evidence of new or increased use of home care services in the routine dataset

Number of participants experiencing emergency department (ED) attendance/hospitalisation with fall/fracture

时间窗: 12 months

Incidence of emergency department (ED) attendance or hospitalisation with fall or fracture, identified using coded evidence of ED attendeance/hospitalisation with fall/fracture in the routine dataset

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew Clegg

Professor

University of Leeds

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