The better health in residents in care homes study: Pilot study

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: The intervention is implemented at the level of the whole care home. The BHiRCH programme is a complex intervention, with 4 key components. These are: 1. Early Warning Tool (Stop and Watch Early Warning Tool) 2. Care Pathway (clinical guidance and decision support system) 3. Structured method for communicating with primary care (SBAR) 4. Implementation support‐ practice development champions and support groups. This is a cluster randomised trial conducted in 14 nursing homes. The 14 homes arerandomised 1:1 between intervention and “usual care”, stratified by location. Randomisation is undertaken by an independent statistician from the CTU using a statistical programme called SAS. All homes are randomised at the same time, just prior to the intervention starting. The intervention takes place over 12 months, with a pre‐intervention period of three months for recruitment and baseline data collection, and a post‐intervention period of one month for completion of outstanding data collection. This intervention acts upon a group of people (the nursing home staff who work with residents and their family carers) and thus the nursing home is the unit of intervention, allocation and analysis. Staff in nursing homes receiving the intervention receive training in the use of a new method of detecting, assessing and communicating changes in the health of residents. Staff, residents and family members may also opt in to individual level data collection, in which further information about their quality of life, perspectives on the care home, and usual care are collected. The CONSORT guidelines for the reporting of randomised trials are followed however, given that this is a pilot study, the analysis will be mainly descriptive and will focus on the recruitment, participant characteristics, other baseline and outcome variables, loss to follow‐up and any adverse events. Descriptive analysis of all the data (including the completeness of data collection) is done and the rates of CONDITION: Specialty: Ageing, Primary sub‐specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease ; Urological and Genital Diseases ; Urinary tract infection, respiratory infection, congestive heart failure, dehydration PRIMARY OUTCOME: Reduction in avoidable acute hospital admissions for respiratory infections, urinary tract infections, dehydration and exacerbation of chronic heart failure. The number of hospital admissions will be recorded from care home records. Residents who have been hospitalised and have consented to individual level data collection will be eligible for analysis for this outcome. Their care records will be analysed using the SIRR tool, and this data will be further assessed by an expert panel of geriatricians to identify whether the hospitalisation was avoidable. This assessment will be carried out shortly after the hospitalisation of any resident. INCLUSION CRITERIA: 1. The study implements an enhanced version of usual care and because of the clustered nature of the setting this will be implemented across the care home. All residents will be invited to be involved in the collection of individual level outcome data. 2. Aged 65 and older SECONDARY OUTCOME: 1. Establish whether resident consent procedures allow the collection of sufficient individual level data using the number of residents who have consented at the end of the Pilot Trial; 2. Effectiveness of the implementation strategy is assessed using qualitative data on barriers and facilitators to implementation. This will be recorded from telephone calls with Practice Development Champions on a monthly basis, and from qualitative interviews with care home staff at the end of the Pilot Trial; 3. fidelity to the intervention is assessed using research field notes from telephone calls with Practice Development Champions on a monthly basis, and from qualitative interviews with care home staff at the end of the Pilot Trial; 4. The level of nursing home staff engagement with the intervention is assessed using qualitative interviews with care home staff at the end of the Pilot Trial, and the number of recorded usage of the intervention tools (on a monthly basis); 5. Sustainability of the intervention outside the context of a trial is assessed using qualitative interviews with nursing home staff (at the end of the Trial) and researcher field notes on support provided, from monthly telephone calls with Practice Development Champions; 6. Potential primary and secondary outcomes for a definitive trial are assessed using an analysis of the completeness of data at the end of the pilot trial; 7. Cost and outcome data is measured using an economic evaluation based on prescription medication usage and the CSRI tool, collected monthly from residents who have consented; 8. Probability of the intervention being cost‐effectiveness is assessed using an analysis of prescription medication usage, CSRI data and staff time spent on the intervention, collected monthly from resident care home data and telephone calls with staff; 9. Key cost components through economic analysis and the expected value of perfect information (EVPI) is assessed using an analysis of prescription medication usage, CSRI data and staff time spent on the intervention, collected monthly from resident care home data and telephone calls with staff; 10. Completeness of data collection is assessed using the completion of documentation and return rate of questionnaires on a monthly basis throughout the trial
Epistemonikos ID: f4ff0d2c83ef270f72fc1b868d242e2c44561b7a
First added on: Aug 23, 2024