Recruiting to Clinical Trials on the Telephone – a randomized controlled trial

Abstract

BackgroundInformed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done.MethodsWe examined the use of the telephone for the purpose of informing expectant mothers about The Danish Calmette Study; a randomized clinical trial assessing neonatal Bacille Calmette-Guérin vaccination. Expectant mothers received an invitation letter with a Participant Information Sheet about The Danish Calmette Study, the present trial, and a Consent Form. Two to 4 weeks later we contacted the mothers to discuss potential participation in the present trial. At this initial telephone contact, and after consent from the mothers, we randomized expectant mothers to receive the verbal information about The Danish Calmette Study by telephone, or at a face-to-face consultation. The primary outcome was a communication score, consisting of comprehension of information about The Danish Calmette Study and satisfaction with the information process. The outcome was measured using a questionnaire 2 days after the information was provided, and 2.5 months after the birth of the child.ResultsThe communication score obtained 2 days after information was given was significantly reduced in the telephone group, effect size −0.74 (95% confidence interval (CI), −1.11 to −0.36). The effect sizes of the subscores were −0.87 (95% CI, −1.25 to −0.49) for satisfaction and −0.22 (95% CI, −0.58 to 0.14) for comprehension. The effect sizes were slightly reduced when assessed 2.5 months after the birth.ConclusionThe communication score was reduced in the telephone group. This was due to a reduction in satisfaction, while no difference in the comprehension could be found in comparison to the control group. This may be ethically acceptable as both groups had high satisfaction scores.Trial registrationClinicalTrials.gov, registered on 5 October 2015 with trial registration number NCT02570061.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1680-y) contains supplementary material, which is available to authorized users.

Strategies to enhance pediatric clinical trial participation: A systematic review with narrative synthesis

“…Of the 80 included pediatric recruitment studies, only 1 was a randomized controlled trial. 14 Similar to our findings with pediatric recruitment strategies, a previous review of recruitment strategies for adult trials by Treweek et al 4 demonstrated a large array of strategy recommendations but few that had been rigorously validated. Importantly, the authors of this comprehensive review were unable to identify any pediatric recruitment intervention studies meeting inclusion criteria and commented on the dearth of evidence addressing recruitment to pediatric trials.…”

Strategies for research participant engagement: A synthetic review and conceptual framework

“…When developing our novel framework, we found that the interventions included in our synthetic analysis leveraged a broad range of behavioral strategies beyond financial incentives to boost research participant engagement. Strategies ranged from establishing relationships with research participants through case managers 25 and lay advocates 26 to changing the way that research teams engaged participants, which included leveraging different communication methods—for example, text messaging, 27 phone calls, 28 websites, 29 and video 30 —or locations, such as recruiting in churches. 31 Some strategies influenced the social context in which potential research participants made decisions (e.g.…”

Consentimento por telefone: otimização do recrutamento de participantes de pesquisas

“…Segundo Wong e colaboradores 6 , o recrutamento por telefone, em comparação com o serviço de correio, pode melhorar a eficácia do recrutamento de 7% a 12%, com risco relativo de 1,66. Os resultados aqui apresentados corroboram esse e outros estudos randomizados que compararam o uso do consentimento telefônico com outros métodos 8,13 .…”

“…Ensaio clínico randomizado comparou o consentimento por telefone com o consentimento em consultas e mostrou que não houve diferença significativa nos níveis de compreensão das informações 8 . Outro ensaio clínico randomizado, que investigou o consentimento para rastreamento do câncer colorretal, apontou maior adesão à visita de triagem, bem como maior número de inclusões, no grupo de pacientes contatados por telefone, em comparação com aqueles contatados por carta 6 .…”