SAFER 2: Support and Assessment for Fall Emergency Referrals 2
| ISRCTN | ISRCTN60481756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60481756 |
| Secondary identifying numbers | HTA 07/01/21 |
- Submission date
- 03/03/2009
- Registration date
- 13/03/2009
- Last edited
- 12/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
The aim of this study is to measure the costs and benefits of a protocol for emergency ambulance paramedics to use when caring for older people who have fallen, allowing the paramedic to assess and refer appropriate patients to a community-based falls service.
Who can participate?
Patients aged 65 and over living within the study area who have fallen and for whom a 999 call is made.
What does the study involve?
Ambulance stations in three participating services (London, Wales, East Midlands) are randomly allocated to either the intervention group or the control group. The control group paramedics continue to provide care according to their standard practice. The intervention group paramedics receive additional training, protocols and clinical support to enable them to assess older people and decide whether they need to be taken to the Emergency Department (ED) straight away, or whether they could benefit from being left at home with a referral to a falls service. We compare the costs, processes and outcomes of care for the patients attended by paramedics with the new protocols with those patients attended by paramedics delivering usual care. The most important outcomes are those related to further falls - subsequent 999 calls and ED attendances for falls. We also compare the two groups of patients in terms of fall-related injuries, hospital admissions, quality of life, fear of falling and deaths, and the time spent, costs of care (and any knock on effects) to the NHS, other services, patients and carers. We also gather in-depth information from patients, carers and health care providers (paramedics, ambulance service managers, and falls service staff) about how the new service works, and about any factors which encourage or hinder its use.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Swansea University (UK)
When is the study starting and how long is it expected to run for?
April 2009 to September 2013
Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)
Who is the main contact?
Prof Helen Snooks
h.a.snooks@swansea.ac.uk
Contact information
Scientific
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 513418 |
|---|---|
| h.a.snooks@swansea.ac.uk |
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | SAFER 2 |
| Study objectives | 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. |
| Ethics approval(s) | Approved by MREC for Wales February 2010, ref: 09_MRE09_61 |
| Health condition(s) or problem(s) studied | Falls in older people |
| Intervention | 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: 15 months Previous interventions until 25/07/2012: Total duration of interventions: 7 months |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measures as of 25/07/2012: The rate of further contacts with emergency healthcare providers (999 calls, ED attendances, emergency admissions or death) - both for any cause and specifically for falls, as summarised by: 1. Proportion of patients who suffer these events 2. Interval to first event 3. Event rate Previous primary outcome measures until 25/07/2012: 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 |
| Secondary outcome measures | Current secondary outcome measures as of 25/07/2012: 1. Duration of inpatient episodes 2. Fractures arising from further falls 3. Self-reported further falls 4. Health-related quality of life, as measured by the SF12 5. 'Fear of falling' as measured by the Modified Falls Efficacy Scale 6. Patient satisfaction as measured by the Quality of Care Monitor 7. Change in place of residence 8. Pathway of care as measured by routine ambulance service data on of proportions conveyed to ED, referred to falls service, referred to other providers, or left at scene without further care 9. Durations of: ambulance service job cycle; episode of care; time to falls service response 10. Compliance with guidelines for ambulance service clinical documentation; and referrals; and for falls services follow up 11. Costs of care to NHS and personal social services, estimated by routine data from participating services 12. Self-reported costs incurred by patients and carers 13. Views of ambulance service paramedics, managers and partners on implementation of the intervention 14. Experience and satisfaction of patients receiving the intervention Previous secondary outcome measures until 25/07/2012: 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. |
| Overall study start date | 01/04/2009 |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 6290 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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. |
| Date of first enrolment | 01/04/2009 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
SA2 8PP
United Kingdom
Sponsor information
University/education
Singleton Park
Swansea
SA2 8PP
Wales
United Kingdom
| Website | http://www.swansea.ac.uk |
|---|---|
"ROR" |
https://ror.org/053fq8t95 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/11/2012 | Yes | No | |
| Results article | results | 10/07/2015 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No |
Editorial Notes
12/04/2017: Publication reference added.
04/02/2016: Plain English summary added.
25/07/2012: The following changes were made to the trial record:
1. The target number of participants was updated from 6548 to 6290.
2 The overall trial end date was updated from 30/06/2012 to 30/09/2013.
