Root Cause Analysis: Reducing Informed Consent Declines

Dawn Burke
December 8th, 2014

A lot of focus is often put on the informed consent process for patients entering a clinical trial – and justly so. There’s a plethora of information that needs to be made available and explained clearly so they can make the best decision about their healthcare.

When so much time and money is spent recruiting patients, it can be detrimental to the study when patients are lost at such a crucial stage – especially when the reasons for decline may be preventable. The diagram below illustrates a root cause analysis to reduce the number of patients who decline the consent for “preventable” reasons. It was created and discussed as part of the Metrics Workshop at the 2014 Fall Onsemble Conference. Starting with the initial problem of patients or families declining consent, we worked backwards to determine what a true cause might be and then discussed ways to overcome it. Informed-Consent-Declines

Possible Solutions:

  • Ensure that the staff involved with conducting the consent discussion are “research friendly” and confident
  • Develop some supplementary materials about the study, the condition, and/or your research site, and tailor it to the intended audience
  • If the supplemental materials are about the study, be sure to work ahead and get any IRB approval necessary before recruiting patients
  • Refine internal processes to ensure the patient goes through the recruitment and consent process smoothly and in an appropriate time frame

While these solutions are certainly dependent on the actual root cause, it is important to note the number of variables that may exist with each problem. The answer in many cases may not be just one solution, but rather a combination of several.

Regardless of the solution(s), it is important for sites to document and track this type of information. The only way to determine if it’s a problem that needs to be addressed is to know how often it’s occurring and why. Take the insight gained and turn it into an actionable item.

Editor’s Note: This is part of a series on Root Cause Analysis. View others:
Documenting True Work Effort

Or learn about the Root Cause Analysis process:
Analyzing Clinical Research Performance with Root Cause Analyses

*A special thank you to Beth Harper, president of Clinical Performance Partners, for facilitating the Metrics Workshop and preparing the diagram above.

Learn more

Watch these free, on-demand webinars to learn more methods for improving the informed consent process and reducing the number of consent declines: 

On-Demand Webinar: Making Your Consent Forms Readable