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Cross, Jane L 
ORCID: https://orcid.org/0000-0002-7003-1916, Hammond, Simon P ORCID: https://orcid.org/0000-0002-0473-3610, Shepstone, Lee, Poland, Fiona ORCID: https://orcid.org/0000-0003-0003-6911, Henderson, Catherine, Backhouse, Tamara ORCID: https://orcid.org/0000-0001-8194-4174, Penhale, Bridget ORCID: https://orcid.org/0000-0002-8487-0606, Donell, Simon, Knapp, Martin, Lewins, Douglas, Maclullich, Alasdair, Patel, Martyn, Sahota, Opinder, Smith, Toby O ORCID: https://orcid.org/0000-0003-1673-2954, Waring, Justin, Howard, Robert, Ballard, Clive and Fox, Chris
(2022)
PERFECTED enhanced recovery pathway (PERFECT-ER) versus standard acute hospital care for people after hip fracture surgery who have cognitive impairment: a feasibility cluster randomised controlled trial.
BMJ Open, 12 (2).
ISSN 2044-6055
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Abstract
Objectives: Assess feasibility of a cluster randomised controlled trial (RCT) to measure clinical and cost-effectiveness of an enhanced recovery pathway for people with hip fracture and cognitive impairment (CI). Design: Feasibility trial undertaken between 2016 and 2018. Setting: Eleven acute hospitals from three UK regions. Participants: 284 participants (208 female:69 male). Inclusion criteria: aged >60 years, confirmed proximal hip fracture requiring surgical fixation and CI; preoperative AMTS ≤8 in England or a 4AT score ≥1 in Scotland; minimum of 5 days on study ward; a ‘suitable informant’ able to provide proxy measures, recruited within 7 days of hip fracture surgery. Exclusion criteria: no hip surgery; not expected to survive beyond 4 weeks; already enrolled in a clinical trial. Intervention: PERFECT-ER, an enhanced recovery pathway with 15 quality targets supported by a checklist and manual, a service improvement lead a process lead and implemented using a plan–do–study–act model. Primary and secondary outcome measures: Feasibility outcomes: recruitment and attrition, intervention acceptability, completion of participant reported outcome measures, preliminary estimates of potential effectiveness using mortality, EQ-5D-5L, economic and clinical outcome scores. Results: 282 participants were consented and recruited (132, intervention) from a target of 400. Mean recruitment rates were the same in intervention and control sites, (range: 1.2 and 2.7 participants/month). Retention was 230 (86%) at 1 month and 54%(144) at 6 months. At 3 months a relatively small effect (one quarter of an SD) was observed on health-related quality of life of the patient measured with EQ-5D-5L proxy in the intervention group. Conclusion: This trial design was feasible with modifications to recruitment. Mechanisms for delivering consistency in the PERFECT-ER intervention and participant retention need to be addressed. However, an RCT may be a suboptimal research design to evaluate this intervention due to the complexity of caring for people with CI after hip fracture.
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