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Enhancing the Informed Consent Process Using Shared Decision Making and Consent Refusal Data from the CLEAR III

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Improving informed consent in clinical trials requires studying best practices. A simulation video intervention did not significantly reduce consent refusal rates but did lower overall screen failures in a neurologic trial.

Keywords:
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Area of Science:

  • Neurology
  • Clinical Trials
  • Informed Consent

Background:

  • Informed consent in National Institutes of Health (NIH) randomized, placebo-controlled trials, particularly emergency neurologic trials, is under-researched.
  • Key issues include shared decision-making regarding risks, benefits, and alternatives with patients or representatives.

Purpose of the Study:

  • To evaluate and enhance the informed consent process in a large NIH randomized trial.
  • To assess the impact of a simulation video intervention on consent refusal rates and screen failures.

Main Methods:

  • The Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III (CLEAR III) trial provided data on informed consent practices.
  • Best and worst consent practices were identified and incorporated into a medical simulation video for investigator education.
  • The video was disseminated via webinar to trial sites to improve the informed consent process, with pre- and post-intervention consent refusals compared.

Main Results:

  • Pre-intervention, 1.40% of eligible patients refused consent; post-intervention, 1.10% refused, a difference that was not statistically significant (P=0.312).
  • The incidence of screen failures was significantly lower post-intervention (P=0.006), potentially due to various patient exclusion factors.

Conclusions:

  • The informed consent process in prospective randomized trials can be improved by analyzing trial-specific best practices and patient concerns.
  • Simulation-based education may influence trial efficiency, as indicated by reduced screen failures, even if direct consent refusal rates are not significantly altered.