Aberdeen Centre for Evaluation

Can audit and feedback be applied to target healthcare professionals' recruitment and retention behaviour in RCTs? A mixed methods exploration

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Can audit and feedback be applied to target healthcare professionals' recruitment and retention behaviour in RCTs? A mixed methods exploration

PhD Project - Mojca Cerar

This project is supported by funding from the Economic and Social Research Council (ESRC) – (ES/P000681/1), the lead investigator is Mojca Cerar, with the supervision of Prof Katie Gillies, Dr Beatriz Goulão, Dr Taylor Coffey, Prof Louise Locock, and Prof Jan Clarkson.

One of the biggest challenges to successful clinical trial completion is recruiting an adequate number of participants. An investigation of publicly funded trials found that only 53% reached their original target sample size (1). The consequences of poor recruitment and subsequent trial delays or discontinuations can be substantial, including biased or unusable results, wasted resources, delayed treatment, and ethical problems with exposing participants to risk without any scientific gains (2–4). Hence, recruitment has been identified as one of the top priorities for methodological clinical trial research (5). 

A common practice within trials is for staff, such as trial managers, to share recruitment rates with sites, usually through graphs comparing sites' performance against targets or other sites (6,7). This is often shared with clinical or research staff at sites via newsletters in the hope of changing site staff’s behaviours (6,7). Although this practice aims to change behaviour, it has not been formally conceptualised as a behaviour change strategy, nor has it been grounded in behavioural science within the context of clinical trials. 

This kind of reporting and evaluation of recruitment rates generally hasn’t, but could be, conceptualised as audit and feedback, an intervention with established evidence base for improving clinical practice across healthcare settings (8). Audit and feedback has been defined as “measurement of clinical performance over a specified period of time (audit) and provision of the resulting data to clinicians or clinical teams (feedback)” (8). It assumes that healthcare professionals will be motivated to change their behaviours when feedback highlights how their personal practice is inconsistent with the desired, evidence-based guidelines or the practice of their peers (8). When well-designed, audit and feedback interventions have been found to significantly improve healthcare professionals’ compliance with desired practices across numerous areas of healthcare (8). Moreover, they can often be developed and implemented with limited resources, making them relatively cost-effective (9). However, the effects of audit and feedback can vary across different contexts and can be unreliable without insights into how and when it works best (8,10,11). 

Therefore, to understand whether and how audit and feedback could be an effective behaviour change strategy in clinical trial contexts, it is first important to examine how audit and feedback is currently used in trials and the perceptions of people receiving it. This project explores whether these existing practices of feeding back recruitment rates to sites could be strengthened by drawing on behavioural science and the wider audit and feedback literature from clinical practice. By conceptualising recruitment and retention as behaviours and feedback reporting as a behaviour change intervention, frameworks such as the Behaviour Change Wheel can be used to design a more theory-informed approach. For instance, identifying the underlying determinants of recruitment behaviour, through frameworks such as the COM-B model or the Theoretical Domains Framework, can inform the selection of behaviour change techniques shown to address them.

The specific research objectives of this project are: 

  1. To generate evidence on whether and how audit and feedback is currently used by trial managers to target site staff’s recruitment and/or retention behaviours in clinical trials

  2. To identify the key opportunities and challenges for audit and feedback interventions reported by site staff to target recruitment behaviour

  3. To identify behaviour change techniques and package them into a candidate audit and feedback intervention

  4. To establish the feasibility and acceptability of the audit and feedback intervention through a co-production workshop with site staff and pilot test it within a trial.

References 

  1. Jacques RM, Ahmed R, Harper J, Ranjan A, Saeed I, Simpson RM, et al. Recruitment, consent and retention of participants in randomised controlled trials: a review of trials published in the National Institute for Health Research (NIHR) Journals Library (1997–2020). BMJ Open. 2022 Feb;12(2):e059230. doi:10.1136/bmjopen-2021-059230

  2. Kasenda B, Von Elm E, You J, Blümle A, Tomonaga Y, Saccilotto R, et al. Prevalence, Characteristics, and Publication of Discontinued Randomized Trials. JAMA. 2014 Mar 12;311(10):1045. doi:10.1001/jama.2014.1361

  3. Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: An empirical analysis of recently closed trials. Clin Trials. 2015 Feb;12(1):77–83. doi:10.1177/1740774514558307

  4. Williams RJ, Tse T, DiPiazza K, Zarin DA. Terminated Trials in the ClinicalTrials.gov Results Database: Evaluation of Availability of Primary Outcome Data and Reasons for Termination. Briel M, editor. PLOS ONE. 2015 May 26;10(5):e0127242. doi:10.1371/journal.pone.0127242

  5. Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014 Dec;15(1):32. doi:10.1186/1745-6215-15-32

  6. Bower P, Brueton V, Gamble C, Treweek S, Smith CT, Young B, et al. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014 Dec;15(1):399. doi:10.1186/1745-6215-15-399

  7. The Guide to  Efficient Trial  Management Effectively managing clinical trial [Internet]. on behalf of UK Trial Managers’ Network; 2024. Report The Seventh Edition. Available from: https://www.tmn.ac.uk/resources/34-the-guide-to-efficient-trial-management

  8. Ivers N, Yogasingam S, Lacroix M, Brown KA, Antony J, Soobiah C, et al. Audit and feedback: effects on professional practice. Cochrane Database Syst Rev. 2025;(3). doi:10.1002/14651858.CD000259.pub4

  9. Moore L, Guertin JR, Tardif PA, Ivers NM, Hoch J, Conombo B, et al. Economic evaluations of audit and feedback interventions: a systematic review. BMJ Qual Saf. 2022 Oct;31(10):754–67. doi:10.1136/bmjqs-2022-014727

  10. Foy R, Eccles M, Jamtvedt G, Young J, Grimshaw J, Baker R. What do we know about how to do audit and feedback? Pitfalls in applying evidence from a systematic review. BMC Health Serv Res. 2005 Dec;5(1):50. doi:10.1186/1472-6963-5-50

  11. Duncan EM, Ivers NM, Grimshaw JM. Channelling the force of audit and feedback: averting the dark side. BMJ Qual Saf. 2022 Oct;31(10):695–7. doi:10.1136/bmjqs-2021-014520

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Status

Ongoing