Clinical trial NCT03063268: An Interactive Patient-Centered Consent for Research Using Medical Records
Official title: An Interactive Patient-Centered Consent for Research Using Medical Records
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attitude to Computers
Attitude of Health Personnel
Researcher-Subject Relations
Trust
Communication Research
Keywords: Electronic Consent
Human Behavior
Bioethics
Research Ethics
Electronic Medical Records (EMR)
Electronic Health Records (EHR)
Informed Consent Form
Interactive Consent
Health Record Data
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Richard M. Fairbanks School of Public Health AT IUPUI
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-02-24
Enrollment: 734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline Satisfaction with consent decision
timeFrame: Immediate at baseline
measure: Change from Baseline Satisfaction with consent decision
timeFrame: 1-week follow-up from Baseline
measure: Baseline Understanding of consent content
timeFrame: Immediate at Baseline
measure: Change from Baseline Understanding of consent content
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Understanding of consent content
timeFrame: 6-month follow-up from Baseline
Secondary outcomes:
measure: Baseline Perceived Voluntariness
timeFrame: Immediate at Baseline
measure: Change from Baseline Perceived Voluntariness
timeFrame: 1-week follow-up from Baseline
measure: Baseline Trust in medical researchers
timeFrame: Prior to consent
measure: Change from Baseline Trust in medical researchers
timeFrame: Immediate at Baseline
measure: Change from Baseline Trust in medical researchers
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Trust in medical researchers
timeFrame: 6-month follow-up from Baseline
measure: Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
timeFrame: Immediate at Baseline
measure: Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
timeFrame: 6-month follow-up from Baseline
measure: Engagement with consent information
timeFrame: Immediate at Baseline (only)
measure: Baseline Numeracy Abilities
timeFrame: Immediate at Baseline
measure: Change from Baseline Numeracy Abilities
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Numeracy Abilities
timeFrame: 6-month follow-up from Baseline
measure: Baseline Possibility of using a Computer Application
timeFrame: Immediate at Baseline
measure: Change from Baseline Possibility of using a Computer Application
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Possibility of using a Computer Application
timeFrame: 6-month follow-up from Baseline
measure: Baseline Using new Computer Applications
timeFrame: Immediate at Baseline
measure: Change from Baseline Using new Computer Applications
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Using new Computer Applications
timeFrame: 6-month follow-up from Baseline
measure: Baseline Dissemination & Access of Personal Health Records and Health Information
timeFrame: Immediate at Baseline
measure: Change from Baseline Dissemination & Access of Personal Health Records and Health Information
timeFrame: 1-week follow-up from Baseline
measure: Change from Baseline Dissemination & Access of Personal Health Records and Health Information
timeFrame: 6-month follow-up from Baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida- College of Medicine- Department of Community Health & Family Medicine
name: Ray E Moseley, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University- Purdue University Indianapolis- Richard M. Fairbanks School of Public Health
name: Christopher A Harle, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida- Department of Health Services Research, Management and Policy
name: Arch G Mainous, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harle CA, Golembiewski EH, Rahmanian KP, Brumback B, Krieger JL, Goodman KW, Mainous AG, Moseley RE. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc. 2019 Jul 1;26(7):620-629. doi: 10.1093/jamia/ocz015.