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.

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.

Implementation and use of computerised clinical decision support (CCDS) in emergency pre-hospital care: a qualitative study of paramedic views and experience using Strong Structuration Theory.

BACKGROUND: Computerised clinical decision support (CCDS) has been shown to improve processes of care in some healthcare settings, but there is little evidence related to its use or effects in pre-hospital emergency care. CCDS in this setting aligns with policies to increase IT use in ambulance care, enhance paramedic decision-making skills, reduce avoidable emergency department attendances and improve quality of care and patient experience. This qualitative study was conducted alongside a cluster randomised trial in two ambulance services of the costs and effects of web-based CCDS system designed to support paramedic decision-making in the care of older people following a fall. Paramedics were trained to enter observations and history for relevant patients on a tablet, and the CCDS then generated a recommended course of action which could be logged. Our aim was to describe paramedics' experience of the CCDS intervention and to identify factors affecting its implementation and use. METHODS: We invited all paramedics who had been randomly allocated to the intervention arm of the trial to participate in interviews or focus groups. The study was underpinned by Strong Structuration Theory, a theoretical model for studying innovation based on the relationship between what people do and their context. We used the Framework approach to data analysis. RESULTS: Twenty out of 22 paramedics agreed to participate. We developed a model of paramedic experience of CCDS with three domains: context, adoption and use, and outcomes. Aspects of context which had an impact included organisational culture and perceived support for non-conveyance decisions. Experience of adoption and use of the CCDS varied between individual paramedics, with some using it with all eligible patients, some only with patients they thought were 'suitable' and some never using it. A range of outcomes were reported, some of which were different from the intended role of the technology in decision support. CONCLUSION: Implementation of new technology such as CCDS is not a one-off event, but an ongoing process, which requires support at the organisational level to be effective. TRIAL REGISTRATION: ISRCTN Registry 10538608 . Registered 1 May 2007. Retrospectively registered.

Support and Assessment for Fall Emergency Referrals (SAFER 1): cluster randomised trial of computerised clinical decision support for paramedics.

OBJECTIVE: To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. DESIGN: Cluster trial randomised by paramedic; modelling. SETTING: 13 ambulance stations in two UK emergency ambulance services. PARTICIPANTS: 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. INTERVENTIONS: Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture. MAIN OUTCOME MEASURES: Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care. SAFETY: Further emergency contacts or death within one month. COST-EFFECTIVENESS: Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness. RESULTS: 17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without. CONCLUSIONS: Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture. TRIAL REGISTRATION: ISRCTN Register ISRCTN10538608.