Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants

Randomized Trial to Determine Whether eConsent is Non-Inferior to Standard Consent Among Prospective Biobank Participants

The goal of this trial is to determine whether the Sage eConsent framework (presented using an electronic application) is non-inferior to traditional, paper-based, human-mediated consent-and therefore could be part of an acceptable population screening approach to identifying patients and others with actionable hereditary syndromes-and to increase basic knowledge about patients' informational needs about different aspects of genetic/omic screening. After receiving either 1) the traditional consenting approach, or 2) a consenting approach presented on an electronic tablet, the investigators will test for differences between these two arms in a variety of outcome measures including objective and perceived comprehension, time spent and informational needs, and enrollment decision, among others.

Study Overview

• Status: Completed
• Conditions: Lynch Syndrome
• Intervention / Treatment: Behavioral: Electronic Consent (iPad)

Detailed Description

The usual consent process for MyCode proceeds as follows: each day, trained MyCode consenters receive a list of patients who are eligible to be approached about MyCode and are scheduled to be seen that day in certain clinics in Geisinger's two-state catchment area. (Any Geisinger patient is eligible who has not previously enrolled in, or declined to enroll in, MyCode.) When an eligible patient arrives at the clinic, the consenter approaches them, confirms their identity, and then asks them if they would like to hear about MyCode. If they decline, the consenter thanks the patient for their time and the encounter is over. If the patient agrees, the consenter goes through a script that the MyCode team has developed from the written consent form that highlights the most important aspects of MyCode, including return of actionable results to participants and their primary care physicians, genetic privacy, and data sharing for research purposes. At the end of the script, the consenter invites and answers questions from the patient. Next, the consenter hands the patient the 7-page written consent form and asks if they would like a few minutes to review it. Finally, the consenter asks the patient whether they wish to enroll in MyCode or not and records their answer-Yes, No, or Thinking (i.e., the patient needs more time to consider)-into the patient's electronic health record.

In the present trial, patients are randomized at the individual level to receive either this usual consent or eConsent via iPad app. During the pilot phase of this trial, 11 Research Assistants (RAs) were trained on both MyCode consenting and on this trial's protocol. As per usual care, the RAs receive a daily list of MyCode-eligible patients scheduled to appear in clinic. And, as per usual care, the RAs approach the patient, confirm their identity, and ask if they wish to learn about MyCode. Those who do are then randomized to the usual care (paper) or eConsent (iPad) arm of the trial, according to whether the current time, as indicated by digital stopwatches, ends in an even or odd number. In the paper arm, the consent process proceeds as usual, with only two minor changes: 1) the RA uses the stopwatch to time the duration of the consent encounter (beginning from the moment they are randomized to the paper arm and ending when either the consent process is interrupted-e.g., because the patient is called back to the examination room-or when the consent process terminates with an enrollment decision (Yes, No, or Thinking); and 2) the RA uses a tracking sheet to record MyCode response rate (i.e., patients approached who did not want to hear about MyCode) and study attrition (e.g., consent process was interrupted). In the iPad arm, the RA hands the patient the iPad and explains that the interactive app will tell them all about MyCode. Patients reluctant to use an iPad are encouraged once to try, with the RA showing them that all that is involved is tapping, but patients who continue to resist are switched to the paper arm and this is noted on the tracking sheet. In the iPad arm, the RA also records whether the patient asks the RA any questions about MyCode and, as with the paper arm, when a patient declines to hear about MyCode and when the consent process is interrupted.

In both arms, patients are then asked to complete a survey, which serves as the primary source of data for the study. The survey is administered on paper in the paper arm and on iPad (via the Qualtrics platform) in the iPad arm. The eConsent app generates a random study ID number that is sent to Qualtrics, where the user's click behavior during the consent process (e.g., time spent on each screen and in total, whether the user clicked "learn more" on each page, (in)correct answers to teach-back questions) is anonymously combined with their survey responses. Survey questions are closed-end (true/false, multiple choice, Likert scale) and based on the Quality of Informed Consent and All of Us participant-provided information surveys.

This study is designed to be powered at 99% to detect an effect of modest size (half a point on the comprehension quiz), requiring 526 participants. Very high levels of power (here, 95% or 99%)-as opposed to the more standard benchmark power level of 80%-are desirable in tests of non-inferiority so that investigators can be as certain as possible that an inference of "no effect" is not a Type II error. In the very unlikely event that data collection proceeds much more slowly than it has in the pilot, the study retains 95% power to detect a one-half question effect with only 372 participants.

• Study Type: Interventional
• Enrollment (Actual): 703
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• None

Exclusion Criteria:

• None

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
No Intervention: Control (no intervention); Consented using the traditional, human-mediated consent process already in use for MyCode consenting.
Experimental: Electronic Consent (iPad); Consented using the Sage eConsent framework, which presents participants with an iPad that describes MyCode and allows participants to choose to learn more information at various steps along the process.	Behavioral: Electronic Consent (iPad); Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean objective comprehension: eConsent vs. control	Objective comprehension quiz score measured using 10-item quiz (minimum = 0; maximum = 10; higher scores indicate greater comprehension)	Immediately after consent decision
Mean perceived comprehension: eConsent vs. control	Subjective, self-reported comprehension measures using 8-item survey (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)	Immediately after consent decision
Mean perceived duration of consent process: eConsent vs. control	Survey (1 item) (minimum on item = 1; maximum = 4; higher scores indicate shorter perceived duration)	Immediately after consent decision
Mean perceived ease of consent process: eConsent vs. control	(minimum on item = 1; maximum = 4; higher scores indicate greater perceived ease)	Immediately after consent decision
Item-specific objective comprehension	Item-specific responses to comprehension quiz (10 items) (six multiple choice items with four options each; four true/false items)	Immediately after consent decision
Item-specific perceived comprehension	Item-specific perceived comprehension (8 items) (minimum on each item = 1; maximum = 4; higher scores indicate greater perceived comprehension)	Immediately after consent decision
Time spent considering each element of MyCode	In-app click behavior (time spent per screen) (continuous measure of time in seconds; greater values indicate more time spent)	Measured during consent
Expressed informational needs for each element of MyCode	In-app click behavior (rate of choosing to "learn more" per element) (more clicks indicate greater expressed informational needs)	Measured during consent
Sociodemographic variables	Sociodemographic survey (17 items including discrete and continuous measure; "select all that apply" questions; and the ability to "prefer not to answer")	Immediately after consent decision
Actual duration of consent process	Measured using stopwatch (paper arm) or app (iPad arm). Greater numbers indicate longer duration.	Measured during consent
MyCode enrollment decision	Survey (1 item) (measured as "yes," "no," or "thinking (needs more time)"	Immediately after consent process

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michelle N Meyer, PhD, JD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 19, 2022
• Study Completion (Actual): May 19, 2022

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Inherited conditions; Biobank enrollment
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: 2017-0334; R01CA211723-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected IPD (none of which includes identifiers) will be de-identified and shared. We will consider whether certain demographic variables need to be blurred to prevent identification of participants.
• IPD Sharing Time Frame: Data will be shared no later than publication of results, and will be available indefinitely.
• IPD Sharing Access Criteria: The data will be available to anyone for general research use. It will be shared at CT.gov, Open Science Framework (OSF), or both.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

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