An Interactive Patient-Centered Consent for Research Using Medical Records

Not Applicable

Completed

• Conditions: Attitude of Health Personnel; Researcher-Subject Relations; Attitude to Computers; Trust; Communication Research
• Interventions: Behavioral: Standard E-Consent; Behavioral: Interactive features on E-Consent; Behavioral: Trust-Enhanced Messaging on E-Consent

• Registration Number: NCT03063268
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-24
• Study Start: 2017-11-06
• Status Verified: 2019-08
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 734

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard E-Consent	Standard E-Consent	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.
Interactive Features on E-Consent	Interactive features on E-Consent	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.
Trust-Enhanced Messaged with Interactive Features on E-Consent	Trust-Enhanced Messaging on E-Consent	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.
Trust-Enhanced Messaged with Interactive Features on E-Consent	Interactive features on E-Consent	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.
Trust-Enhanced Messaged with Interactive Features on E-Consent	Standard E-Consent	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.
Interactive Features on E-Consent	Standard E-Consent	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Satisfaction with consent decision	1-week follow-up from Baseline	Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
Baseline Understanding of consent content	Immediate at Baseline	Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)\*
Change from Baseline Understanding of consent content	6-month follow-up from Baseline	Modified version of the Quality of Informed Consent scale, Part B (Joffe et al. 2001); 14-items, 5-point Likert scale (I didn't understand this at all - I understood this very well)\*
Baseline Satisfaction with consent decision	Immediate at baseline	Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)

Secondary Outcome Measures

Name	Time	Method
Baseline Perceived Voluntariness	Immediate at Baseline	Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree)
Engagement with consent information	Immediate at Baseline (only)	Time spent using consent application and click activity; Focused immersion in information (Agarwal \& Karahanna 2000); 5 items, 5-point Likert scale (strongly disagree-strongly agree)
Change from Baseline Perceived Voluntariness	1-week follow-up from Baseline	Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree)
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);	6-month follow-up from Baseline	Consent for past and future EHR data to be shared with researchers for IRB-approved studies (yes/no); Consent for EHR to be linked with biospecimen data and released to researchers (yes/no)
Baseline Using new Computer Applications	Immediate at Baseline	Experiences with computer applications that the participant has never used before
Baseline Dissemination & Access of Personal Health Records and Health Information	Immediate at Baseline	Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records
Change from Baseline Dissemination & Access of Personal Health Records and Health Information	6-month follow-up from Baseline	Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records
Change from Baseline Trust in medical researchers	6-month follow-up from Baseline	Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Change from Baseline Numeracy Abilities	6-month follow-up from Baseline	Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
Baseline Trust in medical researchers	Prior to consent	Trust In Medical Researchers Scale (Mainous et al. 2006); 12 items, 5-point Likert scale (strongly disagree-strongly agree); Aggregate scores range from 0-48 Sub-analysis of the two Trust in Medical Researchers subscales (or TIMRS)- Participant Deception; Researcher Honesty.
Baseline Willingness to participate in research (i.e., allow EHR to be used in research);	Immediate at Baseline	Consent for past and future EHR data to be shared with researchers for IRB-approved studies (yes/no); Consent for EHR to be linked with biospecimen data and released to researchers (yes/no)
Baseline Numeracy Abilities	Immediate at Baseline	Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
Change from Baseline Possibility of using a Computer Application	6-month follow-up from Baseline	Ease of use, comfort with, and improvements associated with Computer application use
Change from Baseline Using new Computer Applications	6-month follow-up from Baseline	Experiences with computer applications that the participant has never used before
Baseline Possibility of using a Computer Application	Immediate at Baseline	Ease of use, comfort with, and improvements associated with Computer application use

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States