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ISRCTN
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ISRCTN60481756
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ClinicalTrials.gov identifier
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Public title
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SAFER 2: Support and Assessment for Fall Emergency Referrals 2
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Scientific title
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Care of older people who fall: evaluation of the clinical and cost effectiveness of new protocols for emergency ambulance personnel to assess and refer to appropriate community based care - a cluster randomised controlled trial
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Acronym
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SAFER 2
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Serial number at source
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HTA 07/01/21
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Study hypothesis
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To assess the benefits and costs for patients and the NHS of new protocols allowing paramedics to assess and refer older people who have fallen to community based care.
More details can be found at: http://www.hta.ac.uk/1802
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Lay summary
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Ethics approval
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Submitted to South East Wales REC D in March 2009. Approval pending as of 03/03/2009.
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Study design
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Cluster randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Falls in older people
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Participants - inclusion criteria
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1. Both males and females, aged 65 and over
2. Patients who have fallen and for whom a 999 call is made
3. The faller has to live within the study area
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Participants - exclusion criteria
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In order to maximise generalisability of findings to this group of frail patients with complex needs, no patients will be excluded due to other conditions or competence.
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Anticipated start date
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01/04/2009
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Anticipated end date
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30/06/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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6,548
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Interventions
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Health technology being assessed: a protocol for the care of older people who have fallen, allowing emergency ambulance personnel to assess and refer patients to appropriate community based care. To maximise effectiveness, training, clinical support and referral arrangements will be agreed and implemented in each service as part of the intervention. Costs, processes and outcomes of care for patients, NHS and social care will be compared for patients attended by paramedics based at intervention stations and trained to use the new protocol, with those attended by paramedics based at control stations, delivering usual care.
Total duration of interventions: 7 months
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Primary outcome measure(s)
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Patient outcome indicators at 1 and 6 months
(From routinely collected data from the ambulance service and ED)
- Further emergency healthcare contacts (999 call or ED attendance) for fall per recruited faller and time to first contact
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Secondary outcome measure(s)
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1. Patient outcome indicators at 1 and 6 months:
1.1. Emergency hospital admission (and those that are fall related) and length of stay
1.2. Further falls: health related quality of life and self-efficacy - 'fear of falling' (Self-report questionnaire, SF-12® Health Survey, Euroqol EQ-5D, modified Falls Efficacy Scale [mFES])
1.3. Injuries related to further falls, radiologically confirmed (from ED card); place of residence (self-report questionnaire)
1.4. Deaths (from coroners/register of deaths)
1.5. Patient satisfaction and experience (self-report questionnaire, Quality of Care Monitor, semi structured interview)
2. Processes of care: (routine ambulance service, ED data)
The following data will be collected systematically throughout the trial:
2.1. Proportions at index fall: conveyed to ED; referred to falls service and other providers; left at scene with no further care
2.2. Times: spent on scene; ambulance service and total care episode; to falls service response; wider ambulance response times
2.3. Quality of care compliance with: ambulance service treatment and referral protocols including clinical documentation; falls service protocol for follow up contact
2.4. Views of ambulance service paramedics; managers and partner providers of care, concerning implementation of the service
3. Costs of care related to a fall to the NHS and personal social services, and wider system effects (routine service data):
3.1. Incurred by patients and carers, related to care provided (self-report questionnaire). Patient outcome indicators will be recorded at 1 and 6 months after index fall.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Helen
Snooks
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Address
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Swansea University
Singleton Park
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City/town
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Swansea
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Zip/Postcode
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SA2 8PP
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Country
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United Kingdom
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Tel
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+44 (0)1792 513418
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Fax
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+44 (0)1792 513423
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Email
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h.a.snooks@swansea.ac.uk
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Sponsor
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Swansea University (UK)
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Address
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Singleton Park
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City/town
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Swansea
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Zip/Postcode
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SA2 8PP
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Country
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United Kingdom
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Sponsor website:
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http://www.swansea.ac.uk
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Date applied
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03/03/2009
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Last edited
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06/05/2009
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Date ISRCTN assigned
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13/03/2009
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