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Record W4381165899 · doi:10.2196/47121

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

2023· article· en· W4381165899 on OpenAlexvenueno aff
Brittney Greene, Leah Bernardo, Morgan Thompson, James Loughead, Rebecca L. Ashare

Bibliographic record

VenueJMIR Formative Research · 2023
Typearticle
Languageen
FieldMedicine
TopicEthics in Clinical Research
Canadian institutionsnot available
FundersNational Center for Advancing Translational SciencesNational Institutes of HealthPerelman School of Medicine, University of PennsylvaniaUniversity of Pennsylvania
KeywordsLotteryClinical trialIncentiveRandomized controlled trialMedicinePatient recruitmentPsychologyContingency managementLogistic regressionFamily medicineIntervention (counseling)Psychiatry

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.056
metaresearch head score (Gemma)0.102
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesMetaresearch
Consensus categoriesnone
DomainCandidate signal: Methods · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.944
Threshold uncertainty score0.294

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0560.102
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0010.002
Bibliometrics0.0010.001
Science and technology studies0.0010.002
Scholarly communication0.0010.002
Open science0.0020.003
Research integrity0.0020.002
Insufficient payload (model declined to judge)0.0100.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.895
GPT teacher head0.749
Teacher spread0.146 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designNon-randomized trial
DomainMethods
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations3
Published2023
Admission routes1
Has abstractyes

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