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Remote delivery of complex interventions within trials: understanding and applying knowledge from COVID-19 adaptations to guide future delivery, inclusivity and tailoring of trial interventions


   Faculty of Medicine and Health

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  Prof Amanda Farrin  No more applications being accepted  Competition Funded PhD Project (Students Worldwide)

About the Project

The COVID-19 pandemic had a major impact on many aspects of the design and delivery of clinical trials, leading to rapid adaptations to enable trials to continue to operate in an unfamiliar and challenging environment. Current research to understand how to address this impact has focused on adaptations to analysis plans and reporting[1] and adaptions to trial procedures[2], such as managing drug supplies or remote identification, recruitment and data collection processes. Little attention has been paid to methodological challenges arising from adaptations to complex interventions, such as physiotherapy, psychological, behavioural or lifestyle interventions, typically delivered face-to-face by a trained therapist to individual patients or groups of patients. These types of interventions were often rapidly converted to remote delivery, for instance via telephone or video calls, rather than being developed from the outset to be delivered without face-to-face interactions.

Such adaptions to intervention delivery have the potential to cause unintended consequences and affect important aspects of trial generalisability and interpretation. For instance, the ease with which intervention recipients can engage with the intervention may be altered, and this may be intensified for under-served or hard to reach populations, leading to differences in inclusivity and diversity. Issues relating to intervention implementation, such as maintaining fidelity, preventing intervention drift or allowing tailoring to individuals are likely to have different challenges for remotely delivered interventions.

This studentship will aim to increase our understanding of which interventions can be successfully converted to remote delivery, for whom and how. Results will be used to aid the design of future trials operating in resource-constrained settings, such as the NHS, where remote delivery of healthcare interventions is becoming more commonplace.  

The exact plan for the studentship will be determined by both the student’s skills/interests, but it is likely to include some, or all, of the following:

1    Systematic review of the NIHR’s portfolio of trials to identify those in which the intervention was adapted to remote delivery during the COVID-19 pandemic and undertake:

·      Descriptive quantitative analysis of the types of trials, interventions, adaptations, populations, together with key implementation challenges and benefits.

·      Review associated process evaluations to identify any additional unexpected findings

2    Identify a sample of trials for in-depth qualitative study and undertake:

·    Interviews with trial staff (e.g. CTU staff, chief investigators, intervention designers and deliverers) to investigate effects on intervention implementation and fidelity.

·    Interviews with other stakeholders (PPIE representatives and trial participants) to investigate influences on acceptability, inclusivity and inequalities

3    Investigate if changes to delivery mode impact on patient outcomes and intervention effectiveness potentially via a review of the results of completed trial results

4    Develop guidance on how to adapt complex interventions for remote delivery in future trials

The proposed supervisory team is multi-disciplinary: AF, a statistician and trialist, who directs the Complex Interventions Division at Leeds Institute of Clinical Trials Research (LICTR) and co-leads the TMRP Health Informatics Working Group. SS, a behavioural scientist and principal investigator of multiple clinical trials involving remotely delivered complex interventions, who leads the behavioural oncology research group, University of Leeds. KG, a mixed-methods trial methodologist, who leads a programme of research on participant-centred clinical trials at the Health Services Research Unit, University of Aberdeen and co-leads the TMRP Trial Conduct Working Group.

Fieldwork is likely to include interviews, focus groups and/or surveys and may incorporate a placement at the University of Aberdeen. PPIE will be an integral component of this studentship. A PPIE group will be convened for this study consisting of people linked to trials evaluating interventions adapted to remote delivery.

HOW TO APPLY

You are applying for a PhD studentship from the MRC TMRP DTP. A list of potential projects and the application form is available online at:

http://www.methodologyhubs.mrc.ac.uk/about/tmrp-doctoral-training-partnership/

Please complete the form fully. Incomplete forms will not be considered. CVs will not be accepted for this scheme.

Please apply giving details for your first choice project. You can provide details of up to two other TMRP DTP projects you may be interested in at section B of the application form.

Before making an application, applicants should contact the project supervisor to find out more about the project and to discuss their interests in the research before 09 January 2023.

The deadline for applications is 4pm (GMT) 16 January 2023. Late applications will not be considered.

Completed application forms must be returned to: [Email Address Removed]

Informal enquiries may be made to Prof Amanda Farrin - [Email Address Removed]


Funding Notes

Studentships are funded by the Medical Research Council (MRC) for 3 years. Funding will cover tuition fees at the UK rate only, a Research Training and Support Grant (RTSG) and stipend. We aim to support the most outstanding applicants from outside the UK and are able to offer a limited number of bursaries that will enable full studentships to be awarded to international applicants. These full studentships will only be awarded to exceptional quality candidates, due to the competitive nature of this scheme.
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