Condition category
Injury, Occupational Diseases, Poisoning
Date applied
13/03/2014
Date assigned
13/03/2014
Last edited
05/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 patient’s 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 patient’s 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 paramedic’s 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

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

Research & Development
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

  1. 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.

Additional files

Editorial Notes