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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

Hammond, Simon P. and Cross, Jane L. and Shepstone, Lee and Backhouse, Tamara and Henderson, Catherine and Poland, Fiona and Sims, Erika and MacLullich, Alasdair and Penhale, Bridget and Howard, Robert and Lambert, Nigel and Varley, Anna and Smith, Toby O. and Sahota, Opinder and Donell, Simon and Patel, Martyn and Ballard, Clive and Young, John and Knapp, Martin and Jackson, Stephen and Waring, Justin and Leavey, Nick and Howard, Gregory and Fox, Chris (2017) 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, 18 (583). ISSN 1745-6215

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Identification Number: 10.1186/s13063-017-2303-y

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.

Item Type: Article
Official URL: https://www.ncbi.nlm.nih.gov/pmc/journals/388/
Additional Information: © 2017 The Authors © CC BY 4.0
Divisions: Social Policy
Personal Social Services Research Unit
LSE Health
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Sets: Departments > Social Policy
Research centres and groups > Personal Social Services Research Unit (PSSRU)
Research centres and groups > LSE Health
Date Deposited: 21 Feb 2018 14:37
Last Modified: 21 Feb 2018 15:00
URI: http://eprints.lse.ac.uk/id/eprint/86819

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