title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN10538608.
authors.affiliation: Centre for Health Information Research and Evaluation, Swansea University, Swansea UK. h.a.snooks@swansea.ac.uk
authors.forename: Helen
authors.initials: H
authors.lastname: Snooks
authors.forename: Wai-Yee
authors.initials: WY
authors.lastname: Cheung
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Close
authors.forename: Jeremy
authors.initials: J
authors.lastname: Dale
authors.forename: Sarah
authors.initials: S
authors.lastname: Gaze
authors.forename: Ioan
authors.initials: I
authors.lastname: Humphreys
authors.forename: Ronan
authors.initials: R
authors.lastname: Lyons
authors.forename: Suzanne
authors.initials: S
authors.lastname: Mason
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Merali
authors.forename: Julie
authors.initials: J
authors.lastname: Peconi
authors.forename: Ceri
authors.initials: C
authors.lastname: Phillips
authors.forename: Judith
authors.initials: J
authors.lastname: Phillips
authors.forename: Stephen
authors.initials: S
authors.lastname: Roberts
authors.forename: Ian
authors.initials: I
authors.lastname: Russell
authors.forename: Antonio
authors.initials: A
authors.lastname: Sánchez
authors.forename: Mushtaq
authors.initials: M
authors.lastname: Wani
authors.forename: Bridget
authors.initials: B
authors.lastname: Wells
authors.forename: Richard
authors.initials: R
authors.lastname: Whitfield
mesh_terms: D000058:Accidental Falls / Q000191:economics* / Q000401:mortality; D000368:Aged; D000369:Aged, 80 and over; D000488:Allied Health Personnel / Q000193:education; D000552:Ambulances; D034201:Computers, Handheld / Q000191:economics*; D003362:Cost-Benefit Analysis; D020000:Decision Support Systems, Clinical / Q000191:economics*; D004632:Emergency Medical Services / Q000191:economics* / Q000379:methods*; D006801:Humans; D012984:Software; D011795:Surveys and Questionnaires; D016019:Survival Analysis