Communication Research Clinical Trial
Official title:
An Interactive Patient-Centered Consent for Research Using Medical Records
Verified date | August 2019 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 734 |
Est. completion date | August 9, 2019 |
Est. primary completion date | August 9, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Richard M. Fairbanks School of Public Health AT IUPUI |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | Baseline Numeracy Abilities | Level of comfort, understanding, and preferences regarding commonly used mathematical skills (percentages, ratios, and probability) | Immediate at Baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Baseline Possibility of using a Computer Application | Ease of use, comfort with, and improvements associated with Computer application use | Immediate at Baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | Immediate at Baseline | |
Secondary | Change from Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | 1-week follow-up from Baseline | |
Secondary | Change from Baseline Using new Computer Applications | Experiences with computer applications that the participant has never used before | 6-month follow-up from Baseline | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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