Abstract
Background
A failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention.
Methods
This study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire.
Results
Eight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable.
Conclusions
This is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.
A failure of clinical trials to retain participants can influence the trial findings and significantly impact the potential of the trial to influence clinical practice. Retention of participants involves people, often the trial participants themselves, performing a behaviour (e.g. returning a questionnaire or attending a follow-up clinic as part of the research). Most existing interventions that aim to improve the retention of trial participants fail to describe any theoretical basis for the potential effect (on behaviour) and also whether there was any patient and/or participant input during development. The aim of this study was to address these two problems by developing theory- informed, participant-centred, interventions to improve trial retention.
Methods
This study was informed by the Theoretical Domains Framework and Behaviour Change Techniques Taxonomy to match participant reported determinants of trial retention to theoretically informed behaviour change strategies. The prototype interventions were described and developed in a co-design workshop with trial participants. Acceptability and feasibility (guided by (by the Theoretical Framework of Acceptability) of two prioritised retention interventions was explored during a focus group involving a range of trial stakeholders (e.g. trial participants, trial managers, research nurses, trialists, research ethics committee members). Following focus group discussions stakeholders completed an intervention acceptability questionnaire.
Results
Eight trial participants contributed to the co-design of the retention interventions. Four behaviour change interventions were designed: (1) incentives and rewards for follow-up clinic attendance, (2) goal setting for improving questionnaire return, (3) participant self-monitoring to improve questionnaire return and/or clinic attendance, and (4) motivational information to improve questionnaire return and clinic attendance. Eighteen trial stakeholders discussed the two prioritised interventions. The motivational information intervention was deemed acceptable and considered straightforward to implement whilst the goal setting intervention was viewed as less clear and less acceptable.
Conclusions
This is the first study to develop interventions to improve trial retention that are based on the accounts of trial participants and also conceptualised and developed as behaviour change interventions (to encourage attendance at trial research visit or return a trial questionnaire). Further testing of these interventions is required to assess effectiveness.
| Original language | English |
|---|---|
| Article number | 268 |
| Number of pages | 15 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| Early online date | 8 Apr 2022 |
| DOIs | |
| Publication status | Published - 8 Apr 2022 |
Bibliographical note
AcknowledgementsWe would like to thank all of the participants who volunteered their time to contribute to this study. We would also like to thank all of the teams linked to the host trials we worked with to help identify potential participants.
Funding
This research is funded by the Chief Scientist Office of the Scottish Government’s Health and Social Care Department [HIPS/16/46]. KG held a Medical Research Council UK Methodology Fellowship during the delivery of this project [MR/L01193X/1]. The publication was supported through a Health Research Board Trials Methodology Research Network award. MDW acknowledges support from the NIHR Newcastle Biomedical Research Centre. MW acknowledges support from the NIHR Imperial Biomedical Research Centre (BRC). The Health Services Research Unit, Institute of Applied Health Sciences (University of Aberdeen), is core-funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. The funders had no involvement in study design, collection, analysis and interpretation of data, reporting or the decision to publish.
Keywords
- Retention
- Clinical trials
- Intervention development
- Theory
- Behaviour
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Data from: The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials
Newlands, R. (Creator), Duncan, E. (Creator), Treweek, S. (Creator), Elliott, J. (Creator), Presseau, J. (Creator), Bower, P. (Creator), MacLennan, G. (Creator), Ogden, M. (Creator), Wells, M. (Creator), Witham, M. D. (Creator), Young, B. (Creator) & Gillies, K. (Creator), Figshare, 2022
DOI: 10.6084/m9.figshare.c.5939271.v1, https://springernature.figshare.com/collections/The_development_of_theory-informed_participant-centred_interventions_to_maximise_participant_retention_in_randomised_controlled_trials/5939271/1
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The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials
Newlands, R. (Creator), Duncan, E. (Creator), Treweek, S. (Creator), Elliott, J. (Creator), Presseau, J. (Creator), Bower, P. (Creator), MacLennan, G. (Creator), Ogden, M. (Creator), Wells, M. (Creator), Witham, M. D. (Creator), Young, B. (Creator) & Gillies, K. (Creator), Figshare, 2022
DOI: 10.6084/m9.figshare.c.5939271, https://springernature.figshare.com/collections/The_development_of_theory-informed_participant-centred_interventions_to_maximise_participant_retention_in_randomised_controlled_trials/5939271
Dataset