Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care

Abstract Background The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they...

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Main Authors: Vivienne Hanrahan, Louisa Lawrie, Eilidh Duncan, Linda Biesty, Katie Gillies
Format: Article
Language:English
Published: BMC 2022-10-01
Series:Trials
Online Access:https://doi.org/10.1186/s13063-022-06816-6
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author Vivienne Hanrahan
Louisa Lawrie
Eilidh Duncan
Linda Biesty
Katie Gillies
author_facet Vivienne Hanrahan
Louisa Lawrie
Eilidh Duncan
Linda Biesty
Katie Gillies
author_sort Vivienne Hanrahan
collection DOAJ
description Abstract Background The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention. Methods This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders. Results Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy. Conclusion We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates.
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spelling doaj.art-e4c34c67770341c097492e0b9a5580dd2022-12-22T04:31:56ZengBMCTrials1745-62152022-10-0123112910.1186/s13063-022-06816-6Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity careVivienne Hanrahan0Louisa Lawrie1Eilidh Duncan2Linda Biesty3Katie Gillies4University of GalwayUniversity of GalwayUniversity of GalwayUniversity of GalwayUniversity of GalwayAbstract Background The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention. Methods This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders. Results Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy. Conclusion We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates.https://doi.org/10.1186/s13063-022-06816-6
spellingShingle Vivienne Hanrahan
Louisa Lawrie
Eilidh Duncan
Linda Biesty
Katie Gillies
Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
Trials
title Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
title_full Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
title_fullStr Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
title_full_unstemmed Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
title_short Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
title_sort development of a co designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
url https://doi.org/10.1186/s13063-022-06816-6
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