- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03063268
An Interactive Patient-Centered Consent for Research Using Medical Records
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32611
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trust-Enhanced Messaged with 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.
|
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.
Other Names:
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.
Other Names:
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.
|
Experimental: 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.
|
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.
Other Names:
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.
|
Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Satisfaction with consent decision
Time Frame: Immediate at baseline
|
Satisfaction With Decisions scale (Holmes-Rovner et al. 1996); 6-items, 5-point Likert scale (strongly disagree-strongly agree)
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Immediate at baseline
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Change from Baseline Satisfaction with consent decision
Time Frame: 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)
|
1-week follow-up from Baseline
|
Baseline Understanding of consent content
Time Frame: 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)*
|
Immediate at Baseline
|
Change from Baseline Understanding of consent content
Time Frame: 1-week 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)*
|
1-week follow-up from Baseline
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Change from Baseline Understanding of consent content
Time Frame: 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)*
|
6-month follow-up from Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Perceived Voluntariness
Time Frame: 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)
|
Immediate at Baseline
|
Change from Baseline Perceived Voluntariness
Time Frame: 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)
|
1-week follow-up from Baseline
|
Baseline Trust in medical researchers
Time Frame: Prior to consent
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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.
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Prior to consent
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Change from Baseline Trust in medical researchers
Time Frame: Immediate at 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.
|
Immediate at Baseline
|
Change from Baseline Trust in medical researchers
Time Frame: 1-week 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.
|
1-week follow-up from Baseline
|
Change from Baseline Trust in medical researchers
Time Frame: 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.
|
6-month follow-up from Baseline
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Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time Frame: 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)
|
Immediate at Baseline
|
Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time Frame: 1-week 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)
|
1-week follow-up from Baseline
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Change from Baseline Willingness to participate in research (i.e., allow EHR to be used in research);
Time Frame: 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)
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6-month follow-up from Baseline
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Engagement with consent information
Time Frame: Immediate at Baseline (only)
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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)
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Immediate at Baseline (only)
|
Baseline Numeracy Abilities
Time Frame: Immediate at Baseline
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Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
|
Immediate at Baseline
|
Change from Baseline Numeracy Abilities
Time Frame: 1-week follow-up from Baseline
|
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
Time Frame: 6-month follow-up from Baseline
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Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)
|
6-month follow-up from Baseline
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Baseline Possibility of using a Computer Application
Time Frame: Immediate at Baseline
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Ease of use, comfort with, and improvements associated with Computer application use
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Immediate at Baseline
|
Change from Baseline Possibility of using a Computer Application
Time Frame: 1-week follow-up from Baseline
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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
Time Frame: 6-month follow-up from Baseline
|
Ease of use, comfort with, and improvements associated with Computer application use
|
6-month follow-up from Baseline
|
Baseline Using new Computer Applications
Time Frame: Immediate at Baseline
|
Experiences with computer applications that the participant has never used before
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Immediate at Baseline
|
Change from Baseline Using new Computer Applications
Time Frame: 1-week follow-up from Baseline
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Experiences with computer applications that the participant has never used before
|
1-week follow-up from Baseline
|
Change from Baseline Using new Computer Applications
Time Frame: 6-month follow-up from Baseline
|
Experiences with computer applications that the participant has never used before
|
6-month follow-up from Baseline
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Baseline Dissemination & Access of Personal Health Records and Health Information
Time Frame: Immediate at Baseline
|
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
Time Frame: 1-week follow-up from Baseline
|
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
Time Frame: 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
|
6-month follow-up from Baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ray E Moseley, Ph.D, University of Florida- College of Medicine- Department of Community Health & Family Medicine
- Principal Investigator: Christopher A Harle, Ph.D, Indiana University- Purdue University Indianapolis- Richard M. Fairbanks School of Public Health
- Principal Investigator: Arch G Mainous, Ph.D, University of Florida- Department of Health Services Research, Management and Policy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201602061 - N
- R01HD086700 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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