Background
Methods
Overview of the Booster Study
Recruitment pathway
−4 months | −3 months | −2 months | −1 month | −1 week | Main trial start | 1 month | 2 months | 3 months | 9 months | |
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Invitation letter sent | ✔ | |||||||||
Interested individuals contact and screened for brief intervention eligibility | ✔ | |||||||||
Eligible participants are sent brief intervention | ✔ | |||||||||
Participant contacted for DVD use assessment | ✔ | ✔ | ||||||||
Participant contacted and screened for main trial eligibility | ✔ | |||||||||
Face-to-face appointment, consent, baseline assessment and randomisation | ✔ | |||||||||
Participant receives motivational interviewing (excludes control group) | ✔ | ✔ | ||||||||
Face-to-face follow-up appointment | ✔ | |||||||||
Face-to-face follow-up appointment | ✔ |
Recruitment to the brief intervention – primary strategy
Recruitment to the brief intervention – additional strategies
Screening for the brief intervention
Recruitment to the main intervention (RCT)
Results
Overview of recruitment
Recruitment stages
Recruitment to the brief intervention – primary strategy
Recruitment to the brief intervention – additional strategies
Possible barriers to recruitment
Recruitment to the main intervention (RCT)
Comparison of pilot study and full trial recruitment
Pilot study | Full trial | |
---|---|---|
Response rate | 9.9 % | 7.1 % |
Non-contactable for brief intervention screening | 15.8 % | 49.5 % |
Too active for brief intervention | 30.0 % | 18.0 % |
Non-contactable for main trial screening | 43.4 % | 44.7 % |
Eligible for main trial | 78.8 % | 50.0 % |
Consented and randomised | 57.0 % | 50.0 % |
Discussion
Consideration of the study design: did it facilitate recruitment?
Feature/strategy | Booster project examples |
---|---|
Newsletters/mail-outs/flyers (to clinical staff and/or patients) | √ Mail-outs to participants |
Regular visits/phone calls to wards/sites/practices | √Visits were made to local GP surgeries, health trainers/champions and one-stop health shops |
Posters/information leaflets in clinics/wards/notes | √ Poster produced and displayed in GP surgeries |
Inclusion criteria changed/protocol amended | √ |
Presentations to appropriate groups (e.g., at consults, meetings/community-based physiotherapists) | √ Presentations made to relevant organisations, NHS, local authority on becoming involved |
Resource manual for site staff/trained staff in disease area/procedures being investigated/role-play exercises/study day/workshops for recruiters | √ Information provided to research assistants on recruitment |
Advertisement/articles in newspapers/journals, radio interviews | √ Trial manager publicity in the local press, newspaper and radio |
Presentations at national/international meetings | x |
Employed extra staff | √ Administrative assistants hired |
Investigators/recruiting staff meetings | √ Monthly meetings between trial manager and research assistants (in addition to monthly trial management group meetings), weekly email updates on recruitment |
Training/information videos | x |
Incentives for recruiters (e.g., prize draw) | √ Team rewarded at recruitment milestones |
Trial material revised/simplified/customised for specific sites | √ Participant information sheet altered due to reflect added secondary recruitment pathways |
Visits to centres by PIs/senior members of study group | √ Visits to local GP surgeries and to community venues |
Repeated contact by phone/letter to individuals/sites | √ Reminder phone calls to participants |
Increased/changed time points when information provided to potential participants | √ Additional mail-out conducted: extra letter to introduce main trial before screening call |
Supportive statements from opinion leaders | x Supportive statements from current participants rejected by local research ethics committee |
Quality of study team/multi-disciplinary team | √ Multi-disciplinary team from Sheffield Hallam University and University of Sheffield |
Involvement of a Clinical Trials Unit | √ University of Sheffield Clinical Trials Unit, main collaborator in the trial |
Trial manager | √ Dedicated project manager, appropriate cover arranged at a later date due to maternity leave |
Local recruitment co-ordinators | x Centralised recruitment only |
Feasibility work | √ Pilot study recruitment conducted |
Peer-reviewed study protocol | √ Protocol publication |
Simple study design | x Brief intervention and main intervention |
Service user input | √ Expert elders attend design |
Important research question with support of the clinical community | √ Support of public health, physical activity professionals, GPs and research community |
Drug trial/intervention only available in study | √ Motivational interviewing not widely available in community |
Appropriately funded | √ HTA funding secured for 3 years |
Strategy | Outcome |
---|---|
Project manager attended an NIHR recruitment workshop. | No additional suitable strategies to use in the Booster Study were presented. |
Additional recruitment pathway added. General practices were supplied with invitation packs to pass on to potential participants during consultations who may be eligible. | No reply cards were returned from participants who had received an invitation from their GP. There was no monitoring of the number of packs which were distributed to participants. |
Time frame for recruitment was increased to maximise numbers, no extension required other research timescales were compounded. | Recruitment time was increased to ensure an extra mail-out could be conducted. It was understood that these late recruits would not provide 9-month follow-up data. Timescales at the end of the study (e.g. analysis, write-up) were condensed to accommodate this. |
Text messaging and email contact was introduced where possible to check for DVD use during the brief intervention. | Managing incoming messages created new processes which were not managed effectively. The use of text messages and emails could not be used for screening calls, so a large amount of calls were still required. Strategy was phased out towards the end of recruitment. |
Additional letter was sent to encourage those who had received the brief intervention and had increased their physical activity level to call in to complete main trial screening. | Some participants called in, although it did not greatly reduce the amount of calls to be made; it did, however, reduce the ‘cold call’ nature, as participants were made aware they would be contacted again. |
Two administrative assistants were employed on a part-time basis. | Effective strategy to reduce administrative workload of RAs so that they had more time to concentrate on research-related activities. However, as administrative support was introduced at a later date, not all research activities where streamlined to use administrative support fully. |
The final mail-out with smaller numbers and conducted whilst other project activities such as intervention delivery was less demanding. Hard copies of files were organised by the week when they needed to be called rather than their stage in the research. Tight deadlines for recruitment end were imposed. | It was clearer to the RAs what they needed to focus on and by a specific date. This reduced drift in the project timescales, and calls were made on time and received multiple attempts. |
Participants were called the day before the appointment as a reminder, and opportunity to rearrange if the participant could no longer attend was provided. | It was felt that non-attendance still impacted the efficient use of room bookings and RA time. |
Missed opportunities to understand recruitment from the pilot study
Non-contactable participants
Lack of provision for non-English speakers
Low rates of participant randomisation
Staffing/resource issues
Conclusions
Lessons learnt
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Community-based RCTs in which investigators cannot use traditional care pathways for recruitment face challenges different from those in studies conducted with clinical populations.
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Researchers who rely on large-scale mail-outs may need to consider multiple recruitment pathways to suit the needs of diverse communities, and the early inclusion of such groups should be fully considered.
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Recruitment into an RCT should involve as few stages as possible to reduce the ‘funnel effect’. When this cannot be avoided, experienced researchers should provide guidance to ensure processes, workload and timescales are efficient and realistic to prevent the unnecessary loss of eligible participants.
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Complex recruitment designs place a greater importance on a thorough understanding of pilot study data to ensure that substantial changes to the recruitment strategies can be made if required. Time and cost should be written into research bids to ensure that changes and contingency plans can be added to the project.
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Get the basics right; staffing and data-handling processes should be time-effective and organised. Greater use of automated data management systems that prompt follow-up data capture points, for example, or that capture recruitment success via setting or approach would have greatly improved the experience and subsequent insights of the Booster Study.
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Those involved in the recruitment of participants for complex studies such as the Booster Study should be fully informed of the research question, research design and eligibility criteria, and appropriate resources and timescales should be applied to support the recruitment process.