TY - JOUR

T1 - Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture

T2 - fracture in the elderly multidisciplinary rehabilitation-phase III (FEMuR III)

AU - Williams, Nefyn

AU - Dodd, Susanna

AU - Hardwick, Ben

AU - Clayton, Dannii

AU - Edwards, Rhiannon Tudor

AU - Charles, Joanna Mary

AU - Logan, Phillipa

AU - Busse, Monica

AU - Lewis, Ruth

AU - Smith, Toby O

AU - Sackley, Catherine

AU - Morrison, Val

AU - Lemmey, Andrew

AU - Masterson-Algar, Patricia

AU - Howard, Lola

AU - Hennessy, Sophie

AU - Soady, Claire

AU - Ralph, Penelope

AU - Dobson, Susan

AU - Dorkenoo, Shanaz

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

PY - 2020/10/16

Y1 - 2020/10/16

N2 - Introduction Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness is lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care. Methods and analysis Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio. Allocation sequence by minimisation programme with a built in random element. Secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks’ follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme. Ethics and dissemination NHS research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication. Registration details ISRCTN28376407 registered on 23/11/2018.

AB - Introduction Proximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness is lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care. Methods and analysis Protocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio. Allocation sequence by minimisation programme with a built in random element. Secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks’ follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme. Ethics and dissemination NHS research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication. Registration details ISRCTN28376407 registered on 23/11/2018.

KW - hip fracture, trauma, falls, community rehabilitation, domicilary, physiotherapy, occupational therapy

U2 - 10.1136/ bmjopen-2020-039791

DO - 10.1136/ bmjopen-2020-039791

M3 - Article

C2 - 33067298

VL - 10

SP - e039791

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 10

ER -