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Completed

NCT Number: NCT03063268

An Interactive Patient-Centered Consent for Research Using Medical Records

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trust-Enhanced Messaging on E-Consent

Behavioral

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: Trust-Enhanced E-Consent

Interactive features on E-Consent

Behavioral

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: Interactive E-Consent

Standard E-Consent

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)*

  4. 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)*

  5. 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)*

Secondary outcomes

  1. 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)

  2. 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)

  3. Baseline Trust in medical researchers

    Time frame: 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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)

  8. 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)

  9. 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)

  10. Engagement with consent information

    Time frame: 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)

  11. Baseline Numeracy Abilities

    Time frame: Immediate at Baseline

    Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)

  12. 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)

  13. Change from Baseline Numeracy Abilities

    Time frame: 6-month follow-up from Baseline

    Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability)

  14. Baseline Possibility of using a Computer Application

    Time frame: Immediate at Baseline

    Ease of use, comfort with, and improvements associated with Computer application use

  15. Change from Baseline Possibility of using a Computer Application

    Time frame: 1-week follow-up from Baseline

    Ease of use, comfort with, and improvements associated with Computer application use

  16. 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

  17. Baseline Using new Computer Applications

    Time frame: Immediate at Baseline

    Experiences with computer applications that the participant has never used before

  18. Change from Baseline Using new Computer Applications

    Time frame: 1-week follow-up from Baseline

    Experiences with computer applications that the participant has never used before

  19. 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

  20. 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

  21. 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

  22. 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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Richard M. Fairbanks School of Public Health AT IUPUI

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 24, 2017
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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