An Interactive Patient-Centered Consent for Research Using Medical Records

University of Florida

Status: Completed

Conditions: Trust; Researcher-Subject Relations; Attitude of Health Personnel; Attitude to Computers; Communication Research

Treatments: Behavioral: Interactive features on E-Consent; Behavioral: Standard E-Consent; Behavioral: Trust-Enhanced Messaging on E-Consent

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03063268

IRB201602061 - N

R01HD086700 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. This study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overall, this study will improve understanding of how to best give patients information about research that uses their health records and data. With this understanding, this study will develop a new computer application that patients can use in their doctors' offices. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research.

Full description

This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content.

Conceptually, the hypothesized effectiveness of this study's new consent application relies on two constructs, interactivity and trust. Many studies have identified the importance of trust in researchers when it comes to people's willingness to participate in research. Moreover, trust in the source of information is critical to participants' evaluations of risk information. And, risk information is an important element of the research consent process. Thus, highlighted relevant messages to participants at the outset of a research consent process. It is expected that these messages will not coerce participants nor will they dramatically alter participants' general trust in researchers. More importantly, empirically assessments of both of these expectations to ensure the application delivers an ethically appropriate consenting experience. However, it is expected that presenting key facts about research data protections, researcher training, and research regulations will increase the likelihood that participants will be willing to learn about research using medical records. In turn, this will increase participants' understanding and help them make a more informed decision. In the absence of these trust-related messages, it is expected that many participants will simply disengage from the details of the consent information and thus make a less informed decision about participating. Next, the investigators' use of interactivity is supported by research on the effectiveness of communications that interactively deliver detail, empower audiences, and allow a self - discovery process. Indeed, an interactive, person-to-person consent process is the standard approach in clinical trials. Therefore, in the new consent application, the interface will allow participants to interactively explore the details that are most important for their personal understanding of research using EHRs and most relevant to their personal information needs and satisfaction with the consent decision. Without this interactive information exploration, which is essentially dynamically tailored to their personal information needs, participants are more likely to be overwhelmed by the volume of information presented and unable to obtain the information they want most. Under these circumstances, participants' overall understanding of the consent information is likely to decrease, and they are likely to make less satisfactory decisions. There are two specific hypotheses: (1) compared to the standard consent, the interactive consent will lead to increased decisional satisfaction and understanding of the consent; and (2) compared to the interactive consent, the interactive, trust-enhanced consent will lead to increased decisional satisfaction and understanding of the consent.

Enrollment: 734 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with a scheduled medical visit at a UF Family Medicine clinic
• Capacitated, english-speaking patients
• Ages 18 and over
• Patients who meets the above criteria and is willing to consent to participate in the trial.

Exclusion criteria

• Patients who do not complete the UF IRB approved informed consent form
• Patients under the age of 18 years of age

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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734 participants in 3 patient groups

Trust-Enhanced Messaged with Interactive Features on E-Consent

Experimental group

Description:

Messaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested.

Treatment:

Behavioral: Trust-Enhanced Messaging on E-Consent

Behavioral: Interactive features on E-Consent

Behavioral: Standard E-Consent

Interactive Features on E-Consent

Experimental group

Description:

Interactive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects.

Treatment:

Behavioral: Interactive features on E-Consent

Behavioral: Standard E-Consent

Standard E-Consent

Active Comparator group

Description:

Standardized text currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.

Treatment:

Behavioral: Standard E-Consent