The New Executive and Appendix Template (NEAT) Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03419832

Enrollment

101

Registered

2018-02-05

Start date

2017-04-04

Completion date

2017-05-23

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comprehension, Informed Consent

Keywords

ARIC

Brief summary

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

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.

Interventions

OTHERNEAT 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.

OTHERStandard Form

The regular IRB approved version.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Comprehension of the NEAT Form	at visit one, up to 24 hours	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.

Secondary

Measure	Time frame	Description
Qualitative Analysis of the Readability and Understandability of the Consent Form by Participants	at visit one, up to 24 hours	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.
Qualitative Analysis of the Format and Design of the Consent Form by Participants	at visit one, up to 24 hours	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.
Qualitative Analysis of the Time of Discussion of the Consent Form by Participants	at visit one, up to 24 hours	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.
Qualitative Analysis of the Format and Design of the Consent Form by Study Team	at visit one, up to 24 hours	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
NEAT Form Study participants will be randomized to the NEAT form and the materials that accompany it (also detailing the ARIC study). 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.	52
Standard Form Study participants will be randomized to the traditional standard consent form (detailing the ARIC study). Standard Form: The regular IRB approved version.	49
Total	101

Baseline characteristics

Characteristic	NEAT Form	Standard Form	Total
Age, Customized Aged 65 or older	52 Participants	49 Participants	101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	—	—	0 Participants
Sex: Female, Male Male	—	—	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 52	0 / 49
other Total, other adverse events	0 / 52	0 / 49
serious Total, serious adverse events	0 / 52	0 / 49

Outcome results

Primary

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.