An Interactive Patient-Centered Consent for Research Using Medical Records
2 other identifiers
interventional
734
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedStudy Start
First participant enrolled
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2019
CompletedAugust 12, 2019
August 1, 2019
1.8 years
February 16, 2017
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (22)
Baseline Perceived Voluntariness
Immediate at Baseline
Change from Baseline Perceived Voluntariness
1-week follow-up from Baseline
Baseline Trust in medical researchers
Prior to consent
Change from Baseline Trust in medical researchers
Immediate at Baseline
Change from Baseline Trust in medical researchers
1-week follow-up from Baseline
- +17 more secondary outcomes
Study Arms (3)
Trust-Enhanced Messaged with Interactive Features on E-Consent
EXPERIMENTALMessaging 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
EXPERIMENTALInteractive 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.
Standard E-Consent
ACTIVE COMPARATORStandardized text currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who do not complete the UF IRB approved informed consent form
- Patients under the age of 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32611, United States
Related Publications (1)
Harle CA, Golembiewski EH, Rahmanian KP, Brumback B, Krieger JL, Goodman KW, Mainous AG, Moseley RE. Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial. J Am Med Inform Assoc. 2019 Jul 1;26(7):620-629. doi: 10.1093/jamia/ocz015.
PMID: 30938751DERIVED
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 24, 2017
Study Start
November 6, 2017
Primary Completion
August 9, 2019
Study Completion
August 9, 2019
Last Updated
August 12, 2019
Record last verified: 2019-08