A randomized implementation trial to increase adoption of evidence-informed consent practices

Erin D. Solomon, Jessica Mozersky, Melody Goodman, Meredith V. Parsons, Kari Baldwin, Annie B. Friedrich, Jenine K. Harris, James M. DuBois

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes. Methods: We conducted a one-year trial with clinical research professionals in the US (N=1284) who have trials open to older adults or focus on Alzheimer's disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after one year. A subset of participants were interviewed (n=43). Results: Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences on adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully. Conclusions: Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having IRBs recommend or require ECPs may be an effective way to increase their use.

Original languageEnglish (US)
JournalJournal of Clinical and Translational Science
DOIs
StateAccepted/In press - 2022

Keywords

  • formatting
  • implementation science
  • informed consent
  • legally authorized representatives
  • plain language
  • research ethics
  • validated assessments of consent

ASJC Scopus subject areas

  • Medicine(all)

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