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Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial

Helen Snooks1*, Wai-Yee Cheung1, Jacqueline Close2, Jeremy Dale3, Sarah Gaze1, Ioan Humphreys6, Ronan Lyons1, Suzanne Mason4, Yasmin Merali5, Julie Peconi1, Ceri Phillips6, Judith Phillips7, Stephen Roberts1, Ian Russell1, Antonio Sánchez1, Mushtaq Wani8, Bridget Wells1 and Richard Whitfield9

Author Affiliations

1 Centre for Health Information Research and Evaluation, Swansea University, Swansea UK

2 Department of Geriatric Medicine at Prince of Wales Hospital, Sydney, Australia

3 Warwick Medical School, University of Warwick, Coventry, UK

4 School of Health and Related Research (ScHARR) University of Sheffield, Sheffield, UK

5 Warwick Business School, University of Warwick, Coventry, UK

6 Institute for Health Research, School of Health Science, Swansea University

7 School of Human Sciences, Swansea University, Swansea UK

8 Department of Geriatric and Stroke Medicine, Morriston Hospital, Swansea, Swansea UK

9 Prehospital Emergency Research Unit (PERU), Welsh Ambulance Services NHS Trust, Cardiff, UK

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BMC Emergency Medicine 2010, 10:2  doi:10.1186/1471-227X-10-2

Published: 26 January 2010

Abstract

Background

Many emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital attendance. The SAFER 1 trial will assess the costs and benefits of a new healthcare technology - hand-held computers with computerised clinical decision support (CCDS) software - to help paramedics decide who needs hospital attendance, and who can be safely left at home with referral to community falls services.

Methods/Design

Pragmatic cluster randomised trial with a qualitative component. We shall allocate 72 paramedics ('clusters') at random between receiving the intervention and a control group delivering care as usual, of whom we expect 60 to complete the trial.

Patients are eligible if they are aged 65 or older, live in the study area but not in residential care, and are attended by a study paramedic following an emergency call for a fall. Seven to 10 days after the index fall we shall offer patients the opportunity to opt out of further follow up. Continuing participants will receive questionnaires after one and 6 months, and we shall monitor their routine clinical data for 6 months. We shall interview 20 of these patients in depth. We shall conduct focus groups or semi-structured interviews with paramedics and other stakeholders.

The primary outcome is the interval to the first subsequent reported fall (or death). We shall analyse this and other measures of outcome, process and cost by 'intention to treat'. We shall analyse qualitative data thematically.

Discussion

Since the SAFER 1 trial received funding in August 2006, implementation has come to terms with ambulance service reorganisation and a new national electronic patient record in England. In response to these hurdles the research team has adapted the research design, including aspects of the intervention, to meet the needs of the ambulance services.

In conclusion this complex emergency care trial will provide rigorous evidence on the clinical and cost effectiveness of CCDS for paramedics in the care of older people who have fallen.

Trial Registration

ISRCTN10538608