PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial

Abstract Background Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including...

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Main Authors: Simon P. Hammond, Jane L. Cross, Lee Shepstone, Tamara Backhouse, Catherine Henderson, Fiona Poland, Erika Sims, Alasdair MacLullich, Bridget Penhale, Robert Howard, Nigel Lambert, Anna Varley, Toby O. Smith, Opinder Sahota, Simon Donell, Martyn Patel, Clive Ballard, John Young, Martin Knapp, Stephen Jackson, Justin Waring, Nick Leavey, Gregory Howard, Chris Fox
Format: Article
Language:English
Published: BMC 2017-12-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-017-2303-y
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author Simon P. Hammond
Jane L. Cross
Lee Shepstone
Tamara Backhouse
Catherine Henderson
Fiona Poland
Erika Sims
Alasdair MacLullich
Bridget Penhale
Robert Howard
Nigel Lambert
Anna Varley
Toby O. Smith
Opinder Sahota
Simon Donell
Martyn Patel
Clive Ballard
John Young
Martin Knapp
Stephen Jackson
Justin Waring
Nick Leavey
Gregory Howard
Chris Fox
author_facet Simon P. Hammond
Jane L. Cross
Lee Shepstone
Tamara Backhouse
Catherine Henderson
Fiona Poland
Erika Sims
Alasdair MacLullich
Bridget Penhale
Robert Howard
Nigel Lambert
Anna Varley
Toby O. Smith
Opinder Sahota
Simon Donell
Martyn Patel
Clive Ballard
John Young
Martin Knapp
Stephen Jackson
Justin Waring
Nick Leavey
Gregory Howard
Chris Fox
author_sort Simon P. Hammond
collection DOAJ
description Abstract Background Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. Methods This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit “suitable informants” (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). Discussion The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt. Trial registration ISRCTN, 99336264 . Registered on 5 September 2016.
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spelling doaj.art-f8051066cbcd432290bdee48f95558252022-12-21T19:20:56ZengBMCTrials1745-62152017-12-0118111010.1186/s13063-017-2303-yPERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trialSimon P. Hammond0Jane L. Cross1Lee Shepstone2Tamara Backhouse3Catherine Henderson4Fiona Poland5Erika Sims6Alasdair MacLullich7Bridget Penhale8Robert Howard9Nigel Lambert10Anna Varley11Toby O. Smith12Opinder Sahota13Simon Donell14Martyn Patel15Clive Ballard16John Young17Martin Knapp18Stephen Jackson19Justin Waring20Nick Leavey21Gregory Howard22Chris Fox23Department of Psychological Sciences, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaSchool of Health Sciences, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaDepartment of Social Policy, London School of Economics and Political ScienceSchool of Health Sciences, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Clinical Trial Unit, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaGeriatric Medicine, University of EdinburghSchool of Health Sciences, Faculty of Medicine and Health Sciences, University of East AngliaDivision of Psychiatry, Faculty of Brain Sciences, University College LondonSchool of Health Sciences, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaSchool of Health Sciences, Faculty of Medicine and Health Sciences, University of East AngliaNottingham University Hospitals NHS TrustNorfolk and Norwich University Hospitals NHS Foundation TrustNorfolk and Norwich University Hospitals NHS Foundation TrustExeter Medical School, University of ExeterFaculty of Medicine and Health, University of LeedsDepartment of Social Policy, London School of Economics and Political ScienceDepartment of Clinical Gerontology, King’s College Hospital NHS Foundation TrustNottingham University Business SchoolNorwich Clinical Trial Unit, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaNorwich Clinical Trial Unit, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaDepartment of Psychological Sciences, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East AngliaAbstract Background Health and social care provision for an ageing population is a global priority. Provision for those with dementia and hip fracture has specific and growing importance. Older people who break their hip are recognised as exceptionally vulnerable to experiencing confusion (including but not exclusively, dementia and/or delirium and/or cognitive impairment(s)) before, during or after acute admissions. Older people experiencing hip fracture and confusion risk serious complications, linked to delayed recovery and higher mortality post-operatively. Specific care pathways acknowledging the differences in patient presentation and care needs are proposed to improve clinical and process outcomes. Methods This protocol describes a multi-centre, feasibility, cluster-randomised, controlled trial (CRCT) to be undertaken across ten National Health Service hospital trusts in the UK. The trial will explore the feasibility of undertaking a CRCT comparing the multicomponent PERFECTED enhanced recovery intervention (PERFECT-ER), which acknowledges the differences in care needs of confused older patients experiencing hip fracture, with standard care. The trial will also have an integrated process evaluation to explore how PERFECT-ER is implemented and interacts with the local context. The study will recruit 400 hip fracture patients identified as experiencing confusion and will also recruit “suitable informants” (individuals in regular contact with participants who will complete proxy measures). We will also recruit NHS professionals for the process evaluation. This mixed methods design will produce data to inform a definitive evaluation of the intervention via a large-scale pragmatic randomised controlled trial (RCT). Discussion The trial will provide a preliminary estimate of potential efficacy of PERFECT-ER versus standard care; assess service delivery variation, inform primary and secondary outcome selection, generate estimates of recruitment and retention rates, data collection difficulties, and completeness of outcome data and provide an indication of potential economic benefits. The process evaluation will enhance knowledge of implementation delivery and receipt. Trial registration ISRCTN, 99336264 . Registered on 5 September 2016.http://link.springer.com/article/10.1186/s13063-017-2303-yDementiaHip fractureFeasibilityAcute careHospitalService improvement
spellingShingle Simon P. Hammond
Jane L. Cross
Lee Shepstone
Tamara Backhouse
Catherine Henderson
Fiona Poland
Erika Sims
Alasdair MacLullich
Bridget Penhale
Robert Howard
Nigel Lambert
Anna Varley
Toby O. Smith
Opinder Sahota
Simon Donell
Martyn Patel
Clive Ballard
John Young
Martin Knapp
Stephen Jackson
Justin Waring
Nick Leavey
Gregory Howard
Chris Fox
PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
Trials
Dementia
Hip fracture
Feasibility
Acute care
Hospital
Service improvement
title PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
title_full PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
title_fullStr PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
title_full_unstemmed PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
title_short PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial
title_sort perfected enhanced recovery perfect er care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion study protocol for a feasibility cluster randomized controlled trial
topic Dementia
Hip fracture
Feasibility
Acute care
Hospital
Service improvement
url http://link.springer.com/article/10.1186/s13063-017-2303-y
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