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

Area of Science:

• Clinical Research
• Implementation Science
• Informed Consent

Background:

• Evidence-informed consent practices (ECPs) can enhance informed consent in clinical trials but are underutilized.
• ECPs include optimizing format, using plain language, assessing understanding, and involving authorized representatives.

Purpose of the Study:

• To evaluate the effectiveness of an implementation science toolkit and social media campaign in increasing the adoption of ECPs among clinical research professionals.
• To assess the impact of the intervention on ECP adoption, intention to adopt, and attitudes towards ECPs.

Main Methods:

• A 1-year trial randomized 1284 US clinical research professionals to an intervention group (toolkit and social media push) or an active control group (online learning module).
• Participants completed baseline and 1-year follow-up surveys. A subset (n=43) was interviewed.

Main Results:

• Higher engagement with the toolkit correlated with a greater likelihood of attempting ECP implementation.
• No significant differences were found in ECP adoption, intention to adopt, or positive attitudes between the intervention and control groups.
• Participants found the toolkit satisfactory and reported increased ECP awareness but cited time constraints as a barrier to fuller engagement.

Conclusions:

• An implementation science approach using a toolkit and social media had a modest impact on increasing ECP use.
• Institutional review boards recommending or requiring ECPs may be a more effective strategy for widespread adoption.