Using pens as an incentive for trial recruitment of older adults: An embedded randomised controlled trial

Abstract

Background: Meeting recruitment targets for randomised controlled trials is challenging. This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. Methods: This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial. Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio. The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial. To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar. Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. Results: The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; p = 0.86). There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. Conclusion: Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. Registration: ISRCTN22202133; SWAT 37.

A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity

“…However, a previous SWAT conducted by the York Trials Unit evaluated the use of pens as an incentive for recruitment into the OTIS trial of older adults and showed no difference in proportion of participants randomised (pen 4.5%; no pen 4.3%, odds ratio (OR) 1.04, 95% CI 0.65–1.67, p = 0.86), or screened (pen 14.2%, no pen 11.7%, OR 1.25, 95% CI 0.94–1.67, p = 0.12), or in time to return screening form (hazard ratio (HR) 1.23, 95% CI 0.94–1.60, p = 0.13). 2 To our knowledge, this is the only previous RCT to evaluate pens to increase trial recruitment, so more evidence was needed. We conducted a methodological ‘study within a trial’ (SWAT) to evaluate the effects of including a small, unconditional financial incentive and/or a pen in the postal recruitment pack on the proportion of participants randomised into the host trial.…”

A systematic review of economic evaluations alongside studies within a trial (SWATs) for improving recruitment and retention in randomised controlled trials

“…Two studies included SWATs with strategies targeting both recruitment and retention. 21,22 The characteristics of the included studies, that is, study (author, date, country), host trial design, participants, SWAT intervention(s) (and comparator(s)), and SWAT outcome(s), are presented in Table 1.…”

Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over: the OTIS RCT

“…As we planned to mail out a large number of invitation packs in order to recruit sufficient participants, we took the opportunity to evaluate the effectiveness of interventions designed to increase recruitment to studies. 23,24 As we were sending out large numbers of postal questionnaires to participants for follow-up data, we also took the opportunity to evaluate interventions aimed at improving response rates to postal questionnaires. 25,26 Any potential participant identified using one of the above strategies was sent a study recruitment pack consisting of an invitation letter (see Report Supplementary Material 1), a participant information sheet (see Report Supplementary Material 2), a consent form (see Report Supplementary Material 3), a screening questionnaire (see Report Supplementary Material 4) and a freepost envelope for returning the completed paperwork.…”