QuinteT Recruitment Intervention (QRI) as applied to ongoing RCTs with recruitment difficulties

Background

The QuinteT Recruitment Intervention (QRI) has been developed by the QuinteT (Qualitative Research Integrated within Trials) team at the University of Bristol, led by Professor Jenny Donovan. The aim of the QRI is to understand the process of recruitment to Randomised Controlled Trials (RCTs) as it actually occurs in clinical centres/sites, to gather evidence about the origin of difficulties quickly (using standard and novel research methods), and then to produce a plan to address the difficulties to be put into effect in close collaboration with the Chief Investigator (CI), Trial Management Group (TMG) and Clinical Trials Unit (CTU).

QRIs (or developmental version) have been completed in 13 RCTs and are underway in at least six more. In 10 of the completed RCTs, recruitment improved so that the pilot phase progressed to a main trial or recruitment was completed; in three cases, the QRI provided data to explain why continuing with recruitment was not possible (two because of insufficient numbers of eligible patients).

The QRI can be applied in the feasibility or pilot stage of a developing RCT or to an RCT that has encountered recruitment difficulties or shortfalls. This document focuses on the conduct of the latter type of QRI.

The QRI is conducted in two main phases:

Phase I: understanding recruitment (led by QRI team)

The aim of Phase I is to understand the recruitment process as it occurs in clinical centres/sites through five major approaches:

  1. Describing and monitoring the patient pathway through eligibility and recruitment

    In collaboration with the CTU, detailed logging of potential RCT participants through screening and eligibility phases in clinical centres will be encouraged. The QRI team will provide an ‘ideal’ recruitment log that can be adapted to the particular RCT, and collaborate in the drawing of recruitment pathways and flow charts to identify opportunities for stream-lining pathways, differences between clinical centres, and any emerging issues with eligibility assessment.

  2. In-depth interviews

    In-depth, semi-structured interviews will be conducted and audio-recorded with members of the TMG, including the CI (Chief Investigator); Principal Investigators in clinical centres and recruitment staff; and (if required) patients eligible for recruitment to the RCT. These interviews will be analysed rapidly using standard content and thematic approaches to provide data about perceptions of evidence and equipoise, the presentation of the trial, the application of the protocol in clinical centres, and insights into perceived recruitment barriers.

  3. Audio-recording of recruitment appointments

    The appointments during which the RCT is presented by recruiters and consent obtained for participation will need to be audio-recorded. This is the most important and novel aspect of the QRI and will require commitment from the recruiting teams. The audio-recordings are analysed using novel targeted ‘Quintet’ methods.1,2 The aim is to identify the clear obstacles and RCT-specific hidden challenges to recruitment.3,4

  4. Study documentation

    Patient information sheets (PIS) and consent forms will be scrutinised to check consistency with other findings from the QRI and identify any aspects that might be unclear or potentially open to misinterpretation. Suggestions may be made to change wording or structure.

  5. Observations of investigator meetings

    TMG meetings, site visits and other investigator meetings may be observed and/or audio-recorded to identify obstacles to recruitment.

Phase II: Feedback to CI/TMG and plan of action (implementation led by RCT CI)

The QRI research team will present summaries of anonymised findings to the RCT CI and TMG (as agreed a priori), identifying the factors that appear to be hindering recruitment and including anonymised supporting evidence. The QRI team will suggest a potential plan of action to improve recruitment, based on the findings from the specific RCT but also including experience from other QRIs for generic issues. The CI/TMG will then need to decide on the content of their plan of action to improve recruitment.

The aspects that the QRI team will be able to work with the RCT team on are likely to include providing feedback and training on generic recruitment issues, such as how to present the RCT’s design and interventions more clearly to improve levels of understanding and informed consent, how to approach patients’ treatment preferences, and, perhaps, facilitating discussions around issues of eligibility assessment, equipoise, and team-working, or potential changes to the protocol – as appropriate.

The responsibility for implementing changes and facilitating the QRI team’s work remain with the CI. Some changes may happen very quickly – for example if the QRI suggests introducing a more balanced presentation of the study; others may require longer – for example reaching a consensus about an aspect of patient eligibility or evidence.

Evaluating the impact of the plan

The log of eligibility and randomisation will be assessed before the plan of action is implemented, and regularly afterwards to check whether recruitment rates are improving. Interviews with recruiters will ask about the acceptability of the QRI and any changes that occur.

Timing and funding of the full-scale QRI

Phase I can be undertaken by a 0.5 FTE post-doctoral qualitative researcher in about three to four months. Phase II requires around six to nine months for implementation and impact. This can vary considerably, depending on the complexity of the RCT and the issues that need to be addressed. The usual cost is around £60-70k for a 12 month QRI (as detailed below). Costs for a QRI lasting 12 months: time for RA (post-doc) 0.5 FTE £25k; time for Donovan or senior member of team (0.1 or 0.2 FTE) £7-10k; University of Bristol indirect/estates c. £28k; consumables (travel, recorders, transcription) c. £5k.

Other options

The Quintet team is developing training and workshop sessions for recruiters. These sessions cover basic generic issues and simple recruitment tips.

References

  1. Donovan, J. L., Mills, N., Smith, M., Brindle, L., Jacoby, A., Peters, T., Frankel, S., Neal, D., Hamdy, F. for the Protect Study Group, 2002. Improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. BMJ, 325, 766-770.
  2. Paramasivan, S., Strong, S., Wilson, C. H., Campbell, B., Blazeby, J. M. & Donovan, J.L., 2015. A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT – quanti-qualitative appointment timing. Trials; 16:88.
  3. Donovan, J. L., Paramasivan, S., de Salis, I. O. C. & Toerien, M. G. 2014. Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials, Trials, 15:5.
  4. Donovan, J, L., Salis, IOCd., Toerien, M.G., Paramasivan, S., Hamdy, F.C. & Blazeby, J.M. 2014. The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials. Journal of Clinical Epidemiology, vol 67 (8), 912 – 920.

Contacts

Principal Investigator
Professor Jenny Donovan
jenny.donovan@bristol.ac.uk

Quintet team contact
Dr Carmel Conefrey
carmel.conefrey@bristol.ac.uk

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