An Interactive Patient-Centered Consent for Research Using Medical Records

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Interactive Patient-Centered Consent for Research Using Medical Records

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

Intervention / Treatment
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* Behavioral: Trust-Enhanced Messaging on E-Consent
* Behavioral: Interactive features on E-Consent
* Behavioral: Standard E-Consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trust-Enhanced Messaged with Interactive Features on E-Consent<br>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. | Behavioral: Trust-Enhanced Messaging on E-Consent<br>* 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.<br>* Other names: Trust-Enhanced E-Consent;Behavioral: Interactive features on E-Consent<br>* 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.<br>* Other names: Interactive E-Consent;Behavioral: Standard E-Consent<br>* Standard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.<br>|
| Experimental: Interactive Features on E-Consent<br>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. | Behavioral: Interactive features on E-Consent<br>* 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.<br>* Other names: Interactive E-Consent;Behavioral: Standard E-Consent<br>* Standard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.<br>|
| Active Comparator: Standard E-Consent<br>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. | Behavioral: Standard E-Consent<br>* Standard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Satisfaction with consent decision | Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree) | Immediate at baseline | 
| Change from Baseline Satisfaction with consent decision | Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree) | 1-week follow-up from Baseline | 
| Baseline Understanding of consent content | 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)* | Immediate at Baseline | 
| Change from Baseline Understanding of consent content | 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)* | 1-week follow-up from Baseline | 
| Change from Baseline Understanding of consent content | 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)* | 6-month follow-up from Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Perceived Voluntariness | Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree) | Immediate at Baseline | 
| Change from Baseline Perceived Voluntariness | Decision Making Control instrument to assess voluntary consent (Miller et. al.,2011); 9-items, 5-point Likert Scale (Strongly disagree-Strongly Agree) | 1-week follow-up from Baseline | 
| Baseline Trust in medical researchers | 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. | Prior to consent | 
| Change from Baseline Trust in medical researchers | 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. | Immediate at Baseline | 
| Change from Baseline Trust in medical researchers | 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. | 1-week follow-up from Baseline | 
| Change from Baseline Trust in medical researchers | 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. | 6-month follow-up from Baseline | 
| Baseline Willingness to participate in research (i.e., allow EHR to be used in research); | 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) | Immediate at Baseline | 
| Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research); | 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) | 1-week follow-up from Baseline | 
| Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research); | 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) | 6-month follow-up from Baseline | 
| Engagement with consent information | 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) | Immediate at Baseline (only) | 
| Baseline Numeracy Abilities | Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability) | Immediate at Baseline | 
| Change from Baseline Numeracy Abilities | Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability) | 1-week follow-up from Baseline | 
| Change from Baseline Numeracy Abilities | Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability) | 6-month follow-up from Baseline | 
| Baseline Possibility of using a Computer Application | Ease of use, comfort with, and improvements associated with Computer application use | Immediate at Baseline | 
| Change from Baseline Possibility of using a Computer Application | Ease of use, comfort with, and improvements associated with Computer application use | 1-week follow-up from Baseline | 
| Change from Baseline Possibility of using a Computer Application | Ease of use, comfort with, and improvements associated with Computer application use | 6-month follow-up from Baseline | 
| Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | Immediate at Baseline | 
| Change from Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | 1-week follow-up from Baseline | 
| Change from Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | 6-month follow-up from Baseline | 
| Baseline Dissemination & Access of Personal Health Records and Health Information | Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records | Immediate at Baseline | 
| Change from Baseline Dissemination & Access of Personal Health Records and Health Information | Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records | 1-week follow-up from Baseline | 
| Change from Baseline Dissemination & Access of Personal Health Records and Health Information | Sharing of personal health record information with trusted scientists, healthcare providers, and past experiences of accessing personal health records | 6-month follow-up from Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electronic Consent, Human Behavior, Bioethics, Research Ethics, Electronic Medical Records (EMR), Electronic Health Records (EHR), Informed Consent Form, Interactive Consent, Health Record Data