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Testing an alternate informed consent process.

Bernice C Yates1, Diane Dodendorf, Judy Lane

  • 1College of Nursing, University of Nebraska Medical Center, 985330 Nebraska Medical Center, Omaha, NE 68198-5330, USA. bcyates@unmc.edu

Nursing Research
|March 18, 2009
PubMed
Summary
This summary is machine-generated.

Using a visual flip chart in clinical trials significantly boosted hypothetical participation rates by 145% compared to traditional methods. This multimedia approach improved understanding and decision-making for potential participants in cardiac rehabilitation studies.

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Area of Science:

  • Clinical research methodology
  • Patient engagement strategies
  • Health communication

Background:

  • Low participation rates in clinical trials are often due to poor understanding of study rationale and perceived loss of treatment control.
  • Effective informed consent is crucial for ethical trial conduct and participant recruitment.

Purpose of the Study:

  • To evaluate an innovative informed consent process using a multimedia flip chart for a future cardiac rehabilitation randomized clinical trial.
  • To assess hypothetical participant willingness to enroll after a visual presentation of the trial.

Main Methods:

  • A 23-page, visually rich flip chart with 24 color photographs was developed to explain study purpose, group differences, and data collection.
  • The flip chart was tested on 35 cardiac rehabilitation participants, assessing their hypothetical participation intent immediately and 24 hours after reviewing the full consent form.
  • Participant feedback on the flip chart and consent process was collected.

Main Results:

  • 54% of participants (19 out of 35) indicated willingness to join the future trial, a 145% increase from a previous study's 22% recruitment rate.
  • No participant altered their decision after reading the complete informed consent document 24 hours later.
  • The majority of participants found the flip chart helpful, informative, and effective in communicating the study's purpose.

Conclusions:

  • Visual aids, such as multimedia flip charts, can enhance informed consent and potentially increase participation rates in clinical trials.
  • Further research is warranted to explore and validate alternative informed consent methods to improve trial recruitment.