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Table 2 Strategies used to minimise contamination in FinCH

From: Contamination in complex healthcare trials: the falls in care homes (FinCH) study experience

Mechanism for potential riskStrategies used in FinCH to minimise the risk
Detail of the intervention in the study documentationDiscussion by research staff at the set-up meetings about the importance of continuing with usual care for the control group to act as a comparator.
NHS clinicians delivering training package to care home staffFalls specialists were asked to sign a confidentiality agreement to state that they wouldn’t share the training manual.
Care home staff and managers move between homesData on the number of care home staff leaving and starting at each home was collected to allow discussion of the results in view of this data. It was however not feasible to collect data on where new staff were joining from and where staff leaving were going to work, however summarised numbers allowed a description of the frequency and extent of movement of care home staff.
Publishing the development of the FinCH intervention and the feasibility trialThe intervention manual was not published prior to the study completion.
Unable to blind therapists, care staff and care home residents to whether they are allocated to the intervention or control armBlinding of research assistants collecting the primary outcome of the number of falls. The FinCH administrator telephoned care homes prior to the research assistant visiting to remind the home that the RA should remain blinded to the group allocation. Cluster randomisation was used at the level of each care home to ensure that the training and delivery of the Guide to Action Tool was delivered across the whole home.
Promotion of the study findings throughout the duration of the trialMeetings with clinical teams and commissioning groups to emphasise that the study findings were not yet ready to implement into practice. The content of the intervention was not described in detail when the study team were invited to present the on-going trial information and conferences and high profile impact events.
FinCH intervention developed using best available evidence and national guidelinesDialogue with clinical teams who were preparing to deliver the FinCH intervention in control sites. The study team engaged in discussion with clinical teams and commissioners regarding the FinCH trial and the risk of delivering the FinCH intervention in control care homes during the trial. Strategies were put in place to allow the clinical teams to continue to deliver and develop their commissioned services in care homes not involved in the FinCH study. The study team ensured they were offering continued engagement with clinical teams reporting on the progress of the study, and directing them to current evidence that was likely to help them to develop strategies to implement their falls programmes, once the outcome of the FinCH trial was known.