Title: Is it possible to develop a complex intervention to improve the outcome of fall-related injuries in people with dementia? (DIFRID)
Funder: Department of Health and Social Care

Abstract: Fall related injuries are a significant cause of morbidity and mortality in people with dementia (PWD). There is presently little evidence to guide the management of such injuries, and yet there are potentially substantial benefits to be gained if the outcome of these injuries could be improved. This 21 month study aims to provide the evidence needed for the design of an appropriate healthcare intervention for such PWD and to assess the feasibility of delivery in the clinical setting. Work Package 1: Systematic Literature review Strategy for reviewing literature: review of bibliographic source, existing investigator reference databases, grey literature and key references as identified from experts in the field to identify studies examining: the health and social care needs of PWD with fall related injuries, outcomes of importance to patients/carers and evidence on the relative effectiveness of interventions. Methods of systematic review will be based on those of the Cochrane Collaboration and realist synthesis. Work package 2: Understanding current practice Design: prospective observational study over 6 months with qualitative study Settings: 3 UK sites (Newcastle, Stockton, Norwich) each including 3 settings: primary care consultations, paramedic attendances and Emergency department (ED) attendances. Target population: PWD presenting with fall related injuries in each setting at each site. Health technology assessed: Procedure for ascertaining person has a diagnosis of dementia, estimation of number of PWD presenting in each setting, identification of services they are directed to after the fall. In each site a subgroup of 20 PWD and their carers will keep a diary of service usage for 3 months, to describe the type and quantity of care accessed and care pathways followed by such individuals. Qualitative interviews to explore their perceptions of what their care needs were, whether they were met, what might have been improved and what outcomes were important to them. Qualitative interviews of care professionals they encounter, to identify their perceptions of the health and social care needs of PWD, ideas for service improvement, barriers and facilitators to change. Work package 3: Intervention development and validation Design: Convening of an expert panel with qualitative study Health technology assessed: the panel will review the results of WP1 and 2; assess the feasibility and appropriate setting for recruiting participants to receive the intervention, assess and prioritise specific elements to be combined in a complex health care intervention, identify the most appropriate setting and professionals required for delivery of the intervention, training needs, identify and prioritise outcomes to be measured. Qualitative study: exploration of acceptability of proposed intervention with a range of stakeholders including those identified in WP2. Work package 4: Pilot implementation Design: Rehearsal of intervention with process evaluation Settings: as WP2 Target population: 15 PWD with a fall related injury in each site Health technology assessed: feasibility of participant recruitment, fidelity of delivery of the intervention, feasibility of outcome measurement. Qualitative study: assessment of factors influencing the acceptability and implementation of the intervention. Final output: Description of a validated complex intervention with accompanying training materials for its delivery and measurement of outcomes.

Lay abstract: People with dementia (PWD) fall over more often than people who do not have dementia. When they fall over, they are more likely to hurt themselves. They do not get better as easily as people without dementia. After hurting themselves PWD may need a lot more help in looking after themselves, or need to move to a care home. They and their carer may not have such a good quality of life after the fall. The NHS and social services find it is expensive to look after people with these injuries. We know that injuries cause problems for PWD, but we do not really know the best way to look after them. This is because there has been little research in this area. Each person is likely to have many different needs, but at the moment, we do not know what these needs are, or how we can meet these needs within the NHS. For instance, would it be better to have a specialist team to look after PWD who fall, or to provide extra training for existing staff looking after PWD in the community? However we do approach this problem, it is important to show that the approach actually works and is good value for money. In this study, we plan to develop and test a package of care that has a good chance of helping PWD recover from their injuries in the ways that are important to them. In the 1st part of the study, the researchers will search for the papers that have already been written about this topic. From these papers, they will try to find out what PWD think they need after a fall. They will look for papers that tried to find out what is the most important part of getting better after a fall. Lastly, they will look for any papers about clinical trials, which have tried to make things better for PWD who have had a fall. In the 2nd part of the study, we will find out what happens to PWD who ask for help after a fall. We will keep a logbook of PWD who see their GP, call an ambulance or go to hospital because they have hurt themselves in a fall. We will do this in Newcastle, Stockton and Norwich. We will check these people’s records to find out if they were kept in hospital, or if they were referred to a clinic. We will ask some people in each place to keep a detailed diary of all the help they had from the NHS and social services. We will then ask if we can interview them and their carers to find out what help they thought they needed after the fall, and what they think we could do better. We will ask them what they think is important about getting better. We will also speak to the staff that looked after them to find out how they think they could do better. In the 3rd part of the study, we will ask a group of experts, PWD and their carers to look at the things we found out in the first two parts of the study. We will ask them to decide what sort of help should be included in a care package people would need after an injury. We will also ask them to decide how we should measure whether the PWD got better. In the 4th part of the study, we will practice doing the things that the expert group decided we should do with just 15 people in each town. This will help us to smooth out any problems in delivering the care package. At the end of the study, we will be able to say whether it is possible to deliver a care package to improve what happens for PWD who hurt themselves in a fall. If it is, we will be able to recommend how to deliver the care package. In the future, it will then be possible to test how well the package works in a full clinical trial.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INJURIES AND ACCIDENTS;NEUROLOGICAL