The UKCRFN Study Intensity Tool V12 Presenter Jo Plumb and Jo Gray Date 24 th May 2016
Background The first UK CRFs needed to assess their workload. UKCRFN Study Intensity Tool was developed from General Clinical Research Centers (USA) model in 2006 The tool is an excel spreadsheet. It is adult or paediatric specific - constantly reviewed and validated by IWG Designed to: Measure activity of nursing, laboratory, imaging and other research activity (up to three more staff groups) Measure intensity/complexity of visits for each group and for total trial Measures whole time equivalent of each group in both per annum and total format (1.0 WTE/A = 37.5hrs p/w 0.2WTE/A = 7.5hrs p/w)
UKCRFN Study Intensity Tool The tool is an excel spreadsheet and has specific pages for adult or paeds
Purpose Aids prospective planning during study set up Assists in defining which groups of workers will be active on the study Assists in calculating research specific time for each group Can be used to calculate staff requirement for a single trial or a portfolio of trials Can assist in the costing of trials and grant bids
Whole Time Equivalent (WTE) Based on staff working 1560 hrs/pa Allows for some sickness and annual leave & mandatory training Calculates staff needs both pa & for whole study 1.0WTE/A = 37.5hr p/w 0.2WTE/A = 7.5hr p/w
Intensity Level The SIT calculates the intensity for each individual visit and the average intensity for the entire study. Intensity Level Numerical (0.1= 6mins) Duration of visit 1 Visit is less than 1 hour Low 2 Visit is at least 1 hour but <1.6 hrs 3 Visit 1.6 hrs but < 3.6 hours 4 Visit 3.6 hrs but < 5.6 hours Intensity Level Descriptive Low Medium Medium Indicates level of complexity/intensity/duration of visits for staff groups and for study overall. Gives a score which equates to a number of hours indicating length of visit at a glance 5 Visit 5.6 hrs but < 10 hours High 6 Visit 10 hours or more High
NIHR/WT Birmingham CRF The data from all CRF intensities is pulled into tables and charts for reports, business cases and workforce plans 2013 was a particularly busy year with 107 new studies and trials accepted through the CRF approval process Requiring the addition of 14 wte to the team if all studies were to open to time and target
NIHR/ WT Birmingham CRF (IRF) An example of the SIT for work force planning / business cases for new posts Eg Inflammation Research Facility a spoke of the main CRF hub currently have 3.8 wte but have intensity wte projection of 7.07wte.
NIHR/ WT Birmingham CRF (IRF) Mix of high, medium and low intensity studies, risk also factored in Roles under review to assess skill mix and increase data support required for each trial Recorded in the MDT section to give a combined WTE - plan to add a data officers Overall CRF Study Intensity High Low Medium 40% 44% 16%
The SIT version 13 (2017) In response to user questionnaires at 0 and 6 months post training we are currently working on a version 13 of the tool which will include multiple tabs for complicated trials and an admin page. The data page will relate to one off data tasks rather than the data associated with each visit which is already counted. The front page will show a total wte and intensity for the whole trial but each arm of phase will have a data set as well. An automated report from CRFManager will pull this data rather than staff entering data manually into spreadsheets. This data will provide detail to allow workload planning as well as more long term (12 months) work force planning.
Acknowledgements The UKCRF Intensity Working Group would like to acknowledge the contributions and assistance of: Nikki Harwood (Manchester) Carol Chapman, (Southampton) Josephine Studham (London) Jo Plumb (Birmingham) Roberto Cayado-Lopez, (Cambridge) Ruth O Connor (Dublin) UKCRF Paediatric Working Group Elizabeth McDowell and Dickon Jackson (Edinburgh) The tool has been adapted from the General Clinical Research Centers (USA) nurse intensity model with their permission.
UKCRFN IWG - Membership Alison Jenkins, Sheffield Julia Sorrell, Sheffield Anna Steele, Exeter Joanna Gray, Birmingham Sharon Cameron, Edinburgh Finny Paterson, Edinburgh Nia Voase, London Derval Reidy, Dublin Lisa Berry, Southampton Dublin Exeter Edinburgh Sheffield Birmingham London Southampton
New portal address: http://ukcrfn.nihr.ac.uk UKCRFN Home page: www.ukcrfnetwork.co.uk