The New Executive and Appendix Template (NEAT) Study

Study Overview
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Brief Summary
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There is evidence that the current design and content provided by most biomedical research informed consent documents do not consistently meet the expectations researchers place on them to effectively inform research participants of information thought to be most important in facilitating their ability to make informed decisions about participation. The need for revisions to the informed consent document design is supported by empirical research.This pilot study will examine the effectiveness of the New Executive and Appendix Template (NEAT) form when used in the consent process for individuals participating in the Atherosclerosis Risk in Communities (ARIC) Neurocognitive Study.

Detailed Description
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The importance of informed consent is to ensure that participants in clinical research are provided the opportunity to make autonomous choices is a paramount ethical premise in human research. The effectiveness of consent document design and consent process to accurately and fully convey the elements of informed consent is critical and deserves further study. Development of an improved informed consent document design for clinical studies would be a valuable contribution to human research. Chunking sentences or phrases in text into related groupings resulted in a positive significant improvement in reading comprehension among students with poor reading skills. Because the information contained in consent documents can be complex, detailed, and novel for potential research participants, the use of a modified form of chunking may be an effective and a low cost way of improving comprehension of the elements of consent. Specifically, the primary objective of the study is to determine if participants who receive the NEAT form report greater comprehension at the end of the consent process, than participants who receive a standard form.

Official Title
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The NEAT Study: An Examination of a Novel Consent Form Design in a Real-world Setting

Conditions
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Comprehension, Informed Consent

Intervention / Treatment
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* Other: NEAT Form
* Other: Standard Form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who are eligible for the ARIC study, with which this pilot study is cooperating. Exclusion Criteria: Any individuals not eligible for the ARIC study.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEAT Form<br>Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study). | Other: NEAT Form<br>* The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.<br>|
| Active Comparator: Standard Form<br>Study participants will be randomized to the traditional standard consent form (detailing the ARIC study). | Other: Standard Form<br>* The regular IRB approved version.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehension of the NEAT Form | Following the consent process, participants will be administered the Comprehension tool to measure their comprehension. The summary scores will be used to address the primary aim of whether or not the NEAT consent form improves participant comprehension. There are 7 questions, each question is rated 0-2 with a total scale of 0-14. Higher values denotes better outcomes. | at visit one, up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants | Subjects were asked about the readability and understandability of the consent form and selected responses from the following options: Much easier to read and understand, Somewhat easier to read and understand, About the same, or Harder/Much harder to read and understand. The frequency of each response was reported. | at visit one, up to 24 hours | 
| Qualitative Analysis of the Format and Design of the Consent Form by Participants | Subjects were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported. | at visit one, up to 24 hours | 
| Qualitative Analysis of the Time of Discussion of the Consent Form by Participants | Subjects were asked about the time of discussion of the consent form and selected from following options: Much shorter time, Somewhat shorter time, About the same time, or Somewhat/Much longer time. The frequency of each response was reported. | at visit one, up to 24 hours | 
| Qualitative Analysis of the Format and Design of the Consent Form by Study Team | The study team member qualitative data about their opinion of using the form will be collected. Study team members were asked about the format and design of the consent form and selected from the following options: Much better format and design, Somewhat better format and design, About the same format and design, or Somewhat worse format and design. The frequency of each response was reported. | at visit one, up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARIC