Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

Bradshaw, Lucy; Montgomery, Alan; Williams, Hywel C; Chalmers, Joanne R; Haines, Rachel H

doi:10.1186/s13063-020-04373-4

Cited by 9 publications

(5 citation statements)

References 15 publications

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“…The results were combined with two previous studies in a meta-analysis, which showed an increase in response rate of 7% (95% CI < 1 to 13%) [9]. Conversely, several subsequent SWATs comparing text message pre-notification versus no pre-notification prior to sending out postal questionnaires found no different in retention rates; one involved parents of babies with eczema [22], one was in adults with kidney stones [23], and one involving adults with depression [24]. We are aware of two studies specifically comparing the effects of a personalised versus standard text message on questionnaire response rates.…”

Section: Discussionmentioning

confidence: 85%

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Cureton

Marian

Barber

et al. 2021

Trials

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Background Use of a person’s name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient’s name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires. Methods Using a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost. Results Between March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message. Conclusion Overall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message. Trial registration GRASP Trial ISRCTN16539266; SWAT Repository ID 35

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Section: Discussionmentioning

confidence: 85%

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Cureton

Marian

Barber

et al. 2021

Trials

View full text Add to dashboard Cite

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“…These findings provide support for our initial scientific premise: targeting both intrinsic motivation (through IP) and extrinsic motivation (through CM) would have the greatest effect on enrollment rates. Many studies cite concerns with incorporating financial incentives, such as lack of funding [48][49][50]. Our data suggest that financial incentives through a lottery-based system can be a cost-effective way to target extrinsic motivation.…”

Section: Overviewmentioning

confidence: 72%

Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial (Preprint)

Greene¹,

Bernardo²,

Thompson³

et al. 2023

Preprint

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BACKGROUND Nearly 1 in 3 clinical trials end prematurely due to under-enrollment. Strategies to enhance recruitment are often implemented without scientific rigor to evaluate efficacy or cost-effectiveness. OBJECTIVE This study evaluated two behavioral economic strategies to improve enrollment and retention rates: information provision (IP) and contingency management (CM; i.e., lottery) across four clinical trials. METHODS A sample of 212 participants were enrolled across four clinical trials focused on tobacco use, HIV, and/or neuroimaging (NCT03169101, NCT03384784, NCT03438188, NCT02837510). The CM condition included a lottery: for each study visit completed, participants received 5 “draws” from a bowl containing 500 “chips” valued at $0, $1, $5, or $100. In the IP condition, text messages that targeted injunctive norms about research (e.g., “Many find it a rewarding way to advance science and be part of a community”) were sent via the Way to Health Platform before all study visits. Participants were randomized to 1 of 4 conditions: IP, CM, IP+CM, and standard recruitment (SR). We performed logistic regression, controlling for sex and study, with condition as a between-subject predictor. Outcomes were percentage who met final eligibility (FE; primary) and intent-to-treat criteria (ITT; secondary). RESULTS Results: Rates of meeting FE and ITT status were: 42.9% and 33.9% for IP+CM; 30.9% and 18.2% for IP only; 20.8% and 18.9% for CM only; and 25% and 12.5% for SR, respectively. In the logistic regressions, females were more likely to meet FE and ITT status than males (ORs= 2.0 and 2.7, respectively, P=.04 and .01, respectively). Although not significant, the IP+CM group was twice as likely to achieve FE status than the SR group (OR=2.3, 95%CI 0.96, 5.4, P=.06). The IP+CM group was significantly more likely to reach ITT status than the SR condition (OR= 3.9, 95%CI 1.3, 11.1, P=.01). Follow-up models suggested that those who received the IP condition (controlling for CM) were significantly more likely to reach FE status (OR=1.9, 95%CI 1.0, 3.6, P=.04). However, CM (controlling for IP) accounted for increased likelihood to reach ITT status (OR=2.3, 95% CI 1.1, 4.7, P=.03). CONCLUSIONS Combining IP and CM strategies may improve rates of recruitment and retention. IP appeared to have increased enrollment, while CM increased retention rates. Evidence from this study provides support for the utility of behavioral economics strategies to improve enrollment and reduce attrition in clinical trials.

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“…These findings provide support for our initial scientific premise: targeting both intrinsic motivation (through IP) and extrinsic motivation (through CM) would have the greatest effect on enrollment rates. Many studies cite concerns with incorporating financial incentives, such as lack of funding [ 48 - 50 ]. Our data suggest that financial incentives through a lottery-based system can be a cost-effective way to target extrinsic motivation.…”

Section: Discussionmentioning

confidence: 99%

Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial

Greene¹,

Bernardo²,

Thompson³

et al. 2023

JMIR Form Res

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Background Nearly 1 in 3 clinical trials end prematurely due to underenrollment. Strategies to enhance recruitment are often implemented without scientific rigor to evaluate efficacy. Evidence-based, cost-effective behavioral economic strategies designed to influence decision-making may be useful to promote clinical trial enrollment. Objective This study evaluated 2 behavioral economic strategies to improve enrollment and retention rates across 4 clinical trials: information provision (IP) and contingency management (CM; ie, lottery). IP targets descriptive and injunctive norms about participating in research and CM provides participants incentives to reinforce a target behavior. Methods A sample of 212 participants was enrolled across 4 clinical trials focused on tobacco use: 2 focused on HIV and 2 focused on neuroimaging. The CM condition included a lottery: for each study visit completed, participants received 5 “draws” from a bowl containing 500 “chips” valued at US $0, US $1, US $5, or US $100. In the IP condition, text messages that targeted injunctive norms about research (eg, “Many find it a rewarding way to advance science and be part of a community”) were sent through the Way to Health platform before all study visits. Participants were randomized to 1 of 4 conditions: IP, CM, IP+CM, or standard recruitment (SR). We performed logistic regression, controlling for sex and study, with condition as a between-subject predictor. Outcomes were the percentage of participants who attended a final eligibility visit (primary), met intent-to-treat (ITT) criteria (secondary), and completed the study (secondary). Recruitment was evaluated by the percentage of participants who attended a final eligibility visit, enrollment by ITT status, and retention by the percentage of participants who completed the study. Results Rates of attending the eligibility visit and meeting ITT status were 58.9% (33/56) and 33.9% (19/56) for IP+CM; 45.5% (25/55) and 18.2% (10/55) for IP only; 41.5% (22/53) and 18.9% (10/53) for CM only; and 37.5% (18/48) and 12.5% (6/48) for SR, respectively. In the logistic regression, females were more likely to meet ITT status than males (odds ratio [OR] 2.7, 95% CI 1.2-5.7; P=.01). The IP+CM group was twice as likely to attend the final eligibility visit than the SR group (OR 2.4, 95% CI 1.1-5.2; P=.04). The IP+CM group was also significantly more likely to reach ITT status than the SR condition (OR 3.9, 95% CI 1.3-11.1; P=.01). Those who received any active intervention (IP, CM, or IP+CM) had a higher study completion rate (33/53, 63.5%) compared to those who received SR (5/12, 41.7%), but this difference was not significant (P=.26). Conclusions Combining IP and CM strategies may motivate participants to participate in research and improve recruitment and retention rates. Evidence from this study provides preliminary support for the utility of behavioral economics strategies to improve enrollment and reduce attrition in clinical trials.

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Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial

Cited by 9 publications

References 15 publications

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial (Preprint)

Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial

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