The New Executive and Appendix Template (NEAT) Study

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

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.

Study Overview

• Status: Completed
• Conditions: Informed Consent; Comprehension
• Intervention / Treatment: Other: NEAT Form; Other: Standard Form

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEAT Form; Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study).	Other: NEAT Form; 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.
Active Comparator: Standard Form; Study participants will be randomized to the traditional standard consent form (detailing the ARIC study).	Other: Standard Form; The regular IRB approved version.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Joseph Andrews, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): May 23, 2017
• Study Completion (Actual): May 23, 2017

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: ARIC
• Other Study ID Numbers: IRB00031904; 5UL1TR001420-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No