SAFER 2: Support and Assessment for Fall Emergency Referrals 2
| ISRCTN | ISRCTN60481756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60481756 |
| Protocol serial number | HTA 07/01/21 |
| Sponsor | Swansea University (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant 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(s) |
Current primary outcome measures as of 25/07/2012: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 25/07/2012: |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/07/2015 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No | |
| Protocol article | protocol | 12/11/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.