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Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial.

ABSTRACT: Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting at-risk family members involves contacting the original cancer cases and asking them to provide information about their at-risk relatives, who must then be contacted for study enrollment. Though this recruitment strategy is common in family trials, few studies have compared influences of patient and relative participation to nonparticipation. Furthermore, although use of cancer registries to identify initial cases has increased, to our knowledge no study has examined the relationship between registries and family recruitment outcomes.This study assessed predictors of case participation and relative enrollment in a recruitment process that utilized state cancer registries. Participation characteristics were analyzed with separate multivariable logistic regressions in three stages: (1) cancer registry-contacted colorectal cancer (CRC) cases who agreed to study contact; (2) study-contacted CRC cases who provided at-risk relative information; and (3) at-risk relatives contacted for intervention participation.Cancer registry source was predictive of participation for both CRC cases and relatives, though relative associations (odds ratios) varied across registries. Cases were less likely to participate if they were Hispanic or nonwhite, and were more likely to participate if they were female or younger than 50 at cancer diagnosis. At-risk relatives were more likely to participate if they were from Utah, if another family member was also participating in the study, or if they had previously had a colonoscopy. The number of eligible cases who had to be contacted to enroll one eligible relative varied widely by registry, from 7 to 81.Family recruitment utilizing cancer registry-identified cancer cases is feasible, but highly dependent on both the strategies and protocols of those who are recruiting and on participant characteristics such as sex, race, or geography. Devising comprehensive recruitment protocols that specifically target those less likely to enroll may help future research meet recruitment goals.Family Colorectal Cancer Awareness and Risk Education Project NCT01274143.

SUBMITTER: Simmons RG

PROVIDER: S-EPMC3691526 | biostudies-literature | 2013 Apr

REPOSITORIES: biostudies-literature

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Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial.

Simmons Rebecca G RG Lee Yuan-Chin Amy YC Stroup Antoinette M AM Edwards Sandra L SL Rogers Amy A Johnson Christopher C Wiggins Charles L CL Hill Deirdre A DA Cress Rosemary D RD Lowery Jan J Walters Scott T ST Jasperson Kory K Higginbotham John C JC Williams Marc S MS Burt Randall W RW Schwartz Marc D MD Kinney Anita Y AY

Trials 20130430

<h4>Background</h4>Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting at-risk family members involves contacting the original cancer cases and asking them to provide information about their at-risk relatives, who must then be contacted for st ...[more]

PMID: 23782890

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Project description:ObjectiveTo assess factors associated with trial participation in the context of a low-risk intervention intended to reduce adverse drug events in recently hospitalized older adults.DesignMixed methods: analysis of data collected during enrollment efforts and focus groups.SettingA large, multispecialty group practice.ParticipantsIndividuals 50 years and older, recently discharged from the hospital and prescribed at least one high-risk medication, were eligible for the trial. Enrollees, decliners, and their caregivers were eligible to participate in focus groups.MeasurementsReasons for declining to participate during the initial invitation as well as reasons for not providing consent were recorded. Focus groups were conducted with eligible individuals to explore reasons for enrolling or declining. We conducted multivariable logistic regression to compare characteristics (including sex, age, healthcare proxy, number and type of medications, visiting nurse services, reason for admission, and length of hospital stay) of those who enrolled with those who did not enroll.ResultsOf 3,606 individuals determined eligible, 3,147 (87%) declined, 98 (3%) verbally consented to participate but did not complete written consent, and 361 (10%) provided written consent and were considered enrolled. Individuals 80 year and older (odds ratio (OR) = 0.44; 95% confidence interval (CI) = 0.30-0.65) and those with visiting nurse services (OR = 0.64; 95% CI = 0.48-0.85) were least likely to enroll. Among those who provided a reason for declining (2,473), the most common was the belief they did not need additional medication assistance (18%). Another 332 (11%) declined because they were receiving visiting nurse services.ConclusionRecruiting older adults recently discharged from the hospital to participate in trials of low-risk, system-level interventions is challenging and may underenroll the oldest individuals and those potentially at the highest risk for adverse events, limiting generalizability of study findings. Alternative study designs may be more effective than individually randomized trials in assessing low-risk, system-level interventions.

Project description:BackgroundNearly 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.ObjectiveThis 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.MethodsA 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.ResultsRates 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).ConclusionsCombining 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.

Dataset Information

Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial.

Publications

Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial.

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