A workforce planning tool for clinical researchers adapted from US clinical research centres has helped staff in the UK with widely accepted metrics that provide recognised, valuable data and evidence, as members of the UK Clinical Research Facility Network intensity working group explain.
The Intensity tool is a research specific workforce planning tool which originated in the general clinical research centres of the USA. With permission it has been adapted and developed for use in the UK. Its development has been driven by the United Kingdom Clinical Research Facilities Network (UKCRFN) commissioned Intensity Working Group (IWG).
The IWG is a group of nurse managers representing Clinical Research Facilities (CRFs) across the UK who ensure that the tool remains relevant to the developing needs of clinical research.
The UKCRFN intensity tool (attached right) was developed in response to the need to quantify clinical activity initially within the CRFs, however its generic applicability across the research setting allows it to be used in other research settings and in both adult and paediatric studies. It can be used individually or collectively within an organisation as a means of predictive workforce planning.
An annual validation exercise is undertaken by the IWG using a standardised study protocol to validate the current version. This also ensures that any changes in practice, for example study administration or care delivery, are addressed
The tool operates using Microsoft Excel and provides a calculation of whole time equivalent (WTE), giving an overall study intensity calculated from the WTE. This can be broken down for core groups including nursing, imaging, laboratory, and human performance staff as required. The multidisciplinary section can be adapted as appropriate, for example clinical trial assistant, medical staff.
Each core group has a separate study intensity score. Study intensity ranges from 1-6 as follows:
- 1-2 Low intensity
- 3-4 Medium intensity
- 5-6 High intensity
Within the tool itself standard procedures are represented as time defined tasks. Each activity and estimated time has been agreed by the Intensity Workstream Group (IWG) 2007. Definitions of each activity are available in the tool for immediate reference and ease of use. Familiarity with these activity definitions and timings ensures that double accounting for time is avoided when activities overlap hence some training from an experienced user is recommended initially.
The tool provides flexibility to alter some time parameters or to add in study specific procedures and allocate timings to these, therefore allowing the user to customise the tool to the study.
Activity is recorded against visits types e.g. baseline visit, follow up visit, as many studies have multiple visits, some of which can be grouped and recorded collectively. The anticipated participant numbers for each visit type are entered into the tool and this gives a calculation of time and intensity for each.
There is also an option of allocating one off time within the study e.g. for protocol development and training. This is often an area not accounted for and yet can be very time consuming, particularly in the study set up period.
The inclusion of other clinical activity not classified as direct patient care but related to the participants’ physical visit ensures that a full representation of staff activity is measured e.g. travel time for outreach visits, study visit preparation.
The amount of time (in years) estimated to complete the study gives a whole time equivalent and WTE per annum.
A recent addition to the tool includes a straightforward calculation of staff costs. The tool allows a cost to be assigned to a core group, and will calculate the cost based on the overall time detailed for the study. This is also displayed per study visit so can be used to identify costs related to a specific study visit type.
The Intensity tool is freely available to research staff who would find it useful via the UKCRFN web portal http://portal.nihr.ac.uk/sites/ukcrf. The IWG provides interactive training workshops, delivered on average over two hours and providing a detailed explanation and the opportunity to practice using the tool with expert support from the IWG (recommended).
To date the workshops have trained 103 people in the use of the tool from a variety of research organizations including CRFs, Biomedical Research Centers, Local Research Networks and Experimental Cancer Medicine Centers.
As the CRFs developed the need for an appropriate workforce planning tool became apparent to justify CRF establishments. Existing tools for the acute NHS setting such as the Nuffield Workforce Planning Tool developed by Hurst did not produce meaningful metrics in a research setting. For example the care of research participants are not reflected by the dependency levels on which the Acuity –Quality Method are based.
It has been suggested that workforce planning is most accurate when a triangulation approach is taken. The Intensity Tool could be completed and the results compared with other less research specific models. A research based model that could be used as a comparator would be the NCRN ‘Workload Measurement Instrument and Complexity Tool’, the purpose of which is very similar to the Intensity tool. The NCRN tool concentrates primarily on the time taken to perform administrative activity but as Coffey et al (2011) noted does not involve the actual treatment delivery.
The estimation of WTE within the UKCRFN Intensity Tool is particularly useful in assessing how many staff are required to run multiple studies, as well as to assess the feasibility of undertaking particular studies. It is also a useful education tool for researchers to demonstrate the actual resources required to conduct a trial and it provides support when reporting activity to fund holders. It also has the advantage of being a “living” tool which has adapted to the changing research environment.
Like any tool it is an aid, and the intensities and WTEs produced requires interpretation by a manager or experienced research practitioner with oversight of the full picture. Any predictions made rely on the study fully recruiting and being completed within the planned time frame. Experienced staff will understand that this is not always achieved. The tool can however be reviewed as the study changes and utilized as an iterative process
The UKCRFN Intensity Tool represents a simple transparent and integrated approach to the assessment of acuity and activity in a research setting. Its annual revalidation ensures that its parameters remain relevant measures and cover the full spectrum of research currently undertaken in a variety of settings.
The wide dissemination and recognition of the metrics produced by the tool means that it is widely accepted as a measure of workforce planning within a research setting. This information is already utilised by the Wellcome Trust Clinical Research Facilities in reporting annual metrics and therefore supports a consistent national approach to metrics reporting. It has also provided supporting evidence in the justification for an increase in resources when presenting business cases for additional research staff.
Briggs, J., Lyddiard, J., Coffey, M. and Berridge, J. (2011) When to say ‘Yes’ in the NHS. Development of a Complexity Scoring System & Management Tool. CRfocus 22:1: 19-22
Coffey, M., Berridge, J., Lyddiard, J. and Briggs, J. (2011) ‘A workload measure instrument for Cancer Clinical Trials’ Applied Clinical Trials. January 2011
Hurst, K. (2002) Selecting and Applying Methods for Estimating the Size and Mix of Nursing Teams. Summary: systematic review of the literature commissioned by the Department of Health, April 2002.
Royal College of Nursing. (2010) Guidance on safe nurse staffing levels in the UK. RCN