What are the objectives of the study?
1. The primary objective of the trial is to compare the rate of falls per participant in the 2 trial arms (GtACH arm and usual practice control arm) during a 3 month period after randomisation.
2. The secondary objectives are to compare between the trial arms over 12 months:
- Rate of falls per participant longer term
- Frequency of fall injuries
- Frequency and type of fractures
- Number of days in hospital
- Number of deaths
- Health and social service use
- Physical activity
- Functional ability
- Quality of life
- Medication use
3. Perform a within trial cost effectiveness and utility analysis from both a NHS and a personal social service perspective
4. To complete a process evaluation to explain the findings from the perspectives of residents and staff
What is the GtACH?
The Guide to Action in Care Homes (GtACH) Tool is a systematic falls risk assessment and action process, co designed by University of Nottingham researcher in conjunction with care home and NHS staff, based on NICE clinical guidelines. It was developed by the NIHR grant applicants utilising Trent RDSU grant funding and consists of 33 domains related to falls risk factors under four domains: falls history, medical history, movement/environment and personal needs. 30 corresponding suggested actions are included alongside the relevant risk factors to prompt action to be taken to reduce, reverse, modify or manage that risk factor. The GtACH feasibility study, sponsored by the University of Nottingham (Sponsor’s reference number 12051), has been published although the GtACH manual (comprising assessment and action materials) has not been published.
The GtACH Intervention Tool comprises of a training package for Falls Leads to deliver to Care Homes, a GtACH manual (comprising assessment and action materials) and a GtACH Poster.
How many trial participants do we need?
1308 care home residents in 66 care homes. Care homes will be randomised on a one to one basis with resident’s participation being based on the care homes randomisation with the aim of having 50% of residents in each arm. All residents will be consented to observations by researchers at baseline and prior to randomisation.
30 - Process Evaluation Observations (Care Home Staff) of GtACH Assessments and Actions
48 - Process Evaluation Focus Group participants. A staff focus group (comprising of an estimated 8 staff) will take place in each of the 6 care homes. Each focus group will be run twice, but with the same participants where possible. Where numbers dictate, multiple focus groups will be held in a care home to facilitate full participation.
36 - Process Evaluation Interview participants. In each of the 6 evaluation care homes key stakeholders will be interviewed. This will include care home staff, falls leads, care home management and (when appropriate) care home residents (or resident/relative dyads). At least 6 interviews will take place in each setting.
How long will the project last?
The study started in May 2016 and will run until the end of April 2019.
Update of trial at May 2018
10 sites have been recruited across the country
87 care homes recruited within these 10 sites
1698 participants recruited in total
FinCH Protocol Paper