Can ambulance paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients that fall?
| ISRCTN | ISRCTN36245726 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36245726 |
| Secondary identifying numbers | 14057 |
- Submission date
- 13/03/2014
- Registration date
- 13/03/2014
- Last edited
- 12/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Shane Clarke
Scientific
Scientific
Rheumatology Unit
The Courtyard
Old Building, Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| s.clarke@bristol.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Screening, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | Can ambulance paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients that fall? |
| Study objectives | Broken bones are painful, often disabling, and cost the NHS £2 billion annually. Tablets reduce the risk of having a fracture in the most vulnerable but the number of people at high risk taking the right treatment (about 1 in 3) is unacceptably low. Part of the problem is poor communication between healthcare providers; for example, GPs are seldom told about their patients who fall by the attending ambulance service. Falls and fracture are closely linked. Each fall that results in an ambulance call might represent an important opportunity to assess a patients fracture risk using a computer programme called FRAX®. The proposed project is a feasibility study to help us design a full trial. The full trial will find out if ambulance crew can collect information from people that fall and help GPs target treatment for osteoporosis at those patients most likely to have a future fracture. In this feasibility study we want to find out whether ambulance staff can obtain the necessary information to estimate a patients fracture risk, and if the GPs will act on the information given to them. We also require information to help us work out how many patients we will need to recruit, and might be at a high risk of fracture. It is also essential to ensure the study methods are acceptable to patients, ambulance staff and GPs before we plan the main trial. Our study involves ambulance staff asking patients additional questions after they have fallen over, and the design includes a control group, whose members will not be informed of their fracture risk. These ethical issues were considered by members of the public. The proposal was felt to be acceptable, with real potential to improve osteoporosis care. A large Medical Research Council study has already successfully used a similar approach. More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14057 On 04/06/2014 the anticipated end date was changed from 28/03/2014 to 01/07/2014. |
| Ethics approval(s) | 12/SC/0604 |
| Health condition(s) or problem(s) studied | Topic: Primary Care Research Network for England, Injuries and Emergencies; Subtopic: Not Assigned, Injuries and Emergencies (all Subtopics); Disease: Injuries and Emergencies, All Diseases |
| Intervention | Calculate future fracture risk: Paramedics will calculate future fracture risk in patients that fall; Transmit fracture risk GP, Paramedics will transmit calculated future fracture risk to patients GPs; Follow Up Length: 3 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Patients on treatment; Timepoint(s): Proportion of patients taking new treatment to reduce future fracture risk |
| Secondary outcome measures | Appropriate investigations; Timepoint(s): The proportion of patients in control and intervention group that are referred for DXA or blood test |
| Overall study start date | 28/06/2013 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100; Description: 50 control 50 intervention |
| Key inclusion criteria | Men and women aged over 50 who fall (inside or outside their place of residence), call an ambulance, and are attended by study paramedics |
| Key exclusion criteria | 1. Patients who, in the paramedics opinion, are medically unstable and for whom it would not be appropriate to delay treatment to ask study questions (for example where the paramedics suspect a cardiac incident). 2. Patients who have fallen in a public place and n the opinion of the treating paramedics should be conveyed without delay. 3. Patients who are deemed to lack capacity (according to the Mental Health Act [2005]) but for whom there is no available carer or consultee. 4. Patients who are admitted to hospital for 24 hours or more. These patients will need to be excluded by the RF prior to consent (pre-existing service arrangements cover inpatients and our principal target population is in primary care). We will continue to monitor patients who fall twice or more during the study period, but count the first fall as the index event. Only the first eligible fall will trigger entry to the study. |
| Date of first enrolment | 28/06/2013 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rheumatology Unit
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Sponsor information
University Hospitals Bristol NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
"ROR" |
https://ror.org/04nm1cv11 |
|---|
Funders
Funder type
Government
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0711-25070
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 | 03/09/2014 | Yes | No | |
| Results article | results | 20/04/2015 | Yes | No |
Editorial Notes
12/10/2018: Publication reference added.
