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REGARD

Hospital ward


Key information

Title:

REGARD study - A feasibility randomised controlled trial of Regional versus General anaesthesia on post-operative delirium in patients with hip fractures

Chief Investigator: Dr Joyce Yeung

Sponsor: University of Warwick - Jane Prewett

Funder: National Institute for Health Research (NIHR)

Registration Number: ISRCTN15165914

Summary:

The REGARD study is a feasibility randomised control trial (RCT). REGARD is a small trial (n=100) looking to recruit patients aged over 65, who are about to undergo surgery for a fractured hip and are suitable to have either Regional Anaesthetic (RA) or General Anaesthetic (GA) during their surgery. The majority of patients that present to hospital with a hip fracture in this age group are often able to tolerate either type of anaesthetic but there is a lack of research into which type of anaesthetic is best for these patients. The study will look at incidence of post-operative delirium, pain, functional outcome and quality of life in participating patients up to 120 days post-surgery. The study aims to see if a larger randomised trial is possible using this trial design to inform standard clinical care practice within the UK.

The trial also includes a qualitative substudy that will look at the effectiveness of patient identification, screening and randomisation procedures. This aspect of the study will explore staff members’ experience of being involved in the trial, as well as what they believe to be potential barriers and facilitators to recruitment.

Sample size:

This is a feasibility trial that aims to recruit 100 patients from approx. 4 sites in the Midlands.

The qualitative substudy will involve approx. 30 participants from the same 4 sites.

Primary outcome:

For this feasibility trial, the primary outcome will be the proportion of eligible patients that are randomised. Other outcome measures will be:

• Proportion of patients/ consultees providing agreement to ongoing study participation.
• Proportion of patients with complete follow-up data.

Patient outcomes:

• Number of patients who develop post-operative delirium (POD) within 7 days post-randomisation in each group using delirium screening tools based on DSM-5 criteria
• Type, severity and duration of POD if present using Memorial Delirium Assessment Scale (MDAS)
• Cognitive function using Addenbrooke Cognitive Examination (ACEiii) or Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE short version)
• Acute pain using Numeric Rating Scale or ABBEY pain scale
• Post-operative morbidity using POMS-HF
• Mobility using Short Physical Performance Battery (SPPB)
• Quality of life- measured using EQ-5D-3L questionnaire at hospital discharge and 120 days
• Length of hospital stay
• Discharge location
• In-hospital and 30 day mortality

Duration:

The trial started recruitment in September 2017 and finished recruitment on 18th September 2018. The follow up period of the trial is 120 days. We aim to complete the trial by 30th January 2019.

REGARD

Please direct your enquiries to the trial team at:

Tel: 02476 575923
Email: REGARD.trial@warwick.ac.uk

Information for participants:

This study has now closed to recruitment.

If you have taken part in the study and would like more information on how your data was collected and stored, please click on the links below.

REGARD Data transparency statement

University of Warwick Research Privacy Notice

If you have any further questions, please contact us using the details above.