Contact information
Type
Scientific
Primary contact
Dr Shane Clarke
ORCID ID
Contact details
Rheumatology Unit
The Courtyard
Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
s.clarke@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14057
Study information
Scientific title
Acronym
Study hypothesis
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
12/SC/0604
Study design
Randomised; Interventional; Design type: Screening, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
28/06/2013
Overall trial end date
01/07/2014
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100; Description: 50 control 50 intervention
Participant 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.
Recruitment start date
28/06/2013
Recruitment end date
01/07/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rheumatology Unit
Bristol
BS2 8HW
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0711-25070
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25186156
Publication citations
-
Protocol
Clarke S, Bradley R, Simmonds B, Salisbury C, Benger J, Marques E, Greenwood R, Shepstone L, Robinson M, Appleby-Fleming J, Gooberman-Hill R, Can paramedics use FRAX (the WHO Fracture Risk Assessment Tool) to help GPs improve future fracture risk in patients who fall? Protocol for a randomised controlled feasibility study., BMJ Open, 2014, 4, 9, e005744, doi: 10.1136/bmjopen-2014-005744.