TY - JOUR
T1 - PERFECTED enhanced recovery pathway (PERFECT-ER) versus standard acute hospital care for people after hip fracture surgery who have cognitive impairment
T2 - a feasibility cluster randomised controlled trial
AU - Cross, Jane L.
AU - Hammond, Simon P.
AU - Shepstone, Lee
AU - Poland, Fiona
AU - Henderson, Catherine
AU - Backhouse, Tamara
AU - Penhale, Bridget
AU - Donell, Simon
AU - Knapp, Martin
AU - Lewins, Douglas
AU - MacLullich, Alasdair
AU - Patel, Martyn
AU - Sahota, Opinder
AU - Smith, Toby O.
AU - Waring, Justin
AU - Howard, Robert
AU - Ballard, Clive
AU - Fox, Chris
N1 - Funding Information:
Funding This work was funded by NIHR Programme Grants for Applied Research (PGfAR) Programme grant number (ref: DTC-RP-PG-0311–12004). the views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care
Funding Information:
This work was funded by NIHR Programme Grants for Applied Research (PGfAR) Programme grant number (ref: DTC-RP-PG-0311 12004). the views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care
Publisher Copyright:
©
PY - 2022/2/28
Y1 - 2022/2/28
N2 - 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. TRIAL REGISTRATION NUMBER: ISRCTN99336264.
AB - 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. TRIAL REGISTRATION NUMBER: ISRCTN99336264.
KW - delirium & cognitive disorders
KW - geriatric medicine
KW - Hip
KW - rehabilitation medicine
UR - http://www.scopus.com/inward/record.url?scp=85125583045&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-055267
DO - 10.1136/bmjopen-2021-055267
M3 - Article
C2 - 35228288
AN - SCOPUS:85125583045
SN - 2044-6055
VL - 12
SP - e055267
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e055267
ER -