OAK

Funding body/stream

NIHR - Research for Patient Benefit

Chief investigator

Dr Shane Clarke

Institution

University Hospitals Bristol NHS Foundation Trust

Start date& duration

1^st January 2013 for 2 years

Amount

£235,573

Summary

Osteoporosis (thin bones) often results in fractures that can be painful and debilitating. 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 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, what proportion of people that fall are at high risk of fracture, and if the GPs will act on the information given to them. We need data to enable us to work out how many patients we will need for the main trial, but just as importantly to establish whether the methods we describe are acceptable to the patients, ambulance staff and GPs.

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.

Impact

If the feasibility study is successful and the main trial has a positive result; that is ambulance paramedics prove a cost-effective means of improving diagnosis and care of primary care patients at risk of fracture, there are potentially significant public health benefits.

The number of people affected by osteoporosis and its consequences is set to rise as a result of our ageing population. Hip fractures alone cost the UK £2.3 billion annually and the government is aiming to reduce NHS spending by £20 billion over the next 4 years.

FRAX® and NICE algorithms allow clinicians to predict the patients most at risk of fracture, and there is an increasing array of medical treatments available to ameliorate fracture risk but only between 15% and 33% of older patients eligible for treatment to reduce fracture risk are prescribed appropriate drugs. Communication about vulnerable patients between health agencies is often poor.

As relatively few patients who fall visit their GP it is logical to actively target this large group of patients opportunistically because of the inherent increased risk of fracture such an event incurs. Even if vulnerability to fracture (osteoporosis and associated clinical risk factors) is present at a similar rate as in the age-matched community (the study will provide more information here), GPs, aided by ambulance paramedics, are likely to be able to detect and treat greater numbers of patients at risk of fracture by accessing a group of people that may not consult frequently. This might be considered a useful extension of the opportunistic case-finding advocated by NICE.

We would advocate working with local Trusts to develop and establish a training package for ambulance paramedics, GPs and NHS commissioners from other regions to share the outcomes of the research and promote improved osteoporosis care (and research) through ambulance services.

Patient and public involvement

Study development:Four strands of patient and public involvement have been central to the proposal's development:

1. We consulted the GWASExternal Reference Group(ERG) to determine whether service users were likely to be amenable to verbal agreement to answer questions relating to fracture risk following a fall. All 5 ERG members thought the proposed study process was ethical and reasonable. Of the study as a whole, they wrote: "what an excellent idea....", "prevention is more cost effective in the long term".

The ERG were concerned the intervention would produce more work for GPs. This prompted a dialogue with GPs and a subsequent change in study design so that the Research Assistant (nurse specialist) calculates fracture risk and translates it into clear advice for the GP.

2. We presented the proposal to annual general meetings of 2 branches of theNational Osteoporosis Society(NOS) and sent the draft proposal to members who expressed an interest in participation. As a result of their comments we have changed the application to improve its readability.

3. We sent the draft proposal to the NOS headquarters. The National Policy Officer made suggestions to improve clarity and accuracy and confirmed support from the charity should this funding application be successful.

4. We held a "Falls Forum", attended by seven members of the public (and carers), with direct experience of falling. Everyone at the forum would be willing to consider participation in the study as presented, and also felt they would be able to give meaningful answers to all except for one FRAX® question if asked by ambulance paramedics. The forum thought the question about rheumatoid arthritis confusing. The study team will exclude this question and determine rheumatoid status later from participants' GPs.

Ongoing Involvement:

Collaboration: The study team will work in close collaboration with patient/public partners who will be invited to form a Patient Advisory Group (PAG) that will meet at six month intervals and also contribute two representatives to the project steering group.

Prior to the study's start, PAG involvement will be important in the development of study materials for submission to the ethics committee, with particular reference to readability and meaning.

As the study progresses, PAG partners will work alongside the rest of the team to help ensure the study reaches its milestones.

Costs: Costs are included for patient/public involvement in line with INVOLVE's guidance.