Polk County Mental Health and Disability Services Regional Evaluation
The Polk County Region oversees the following service delivery programs available to people with disabilities in Polk county: Community Employment, Integrated Services, Integrated Health Homes, Service Coordination, and Community Living. LHPDC acts as an independent evaluator for these services, providing an annual evaluation for each program. LHPDC uses participant interviews, interviews/focus groups, and agency-provided data to evaluation services based on specific outcomes. The outcomes include Participant Satisfaction, Participant Quality of Life, Family and Concerned Other Satisfaction, Participant Empowerment, Community Inclusion, Employment for Self-Sufficiency, Engagement in Employment, Education, Access to Somatic Care, Involvement in the Criminal Justice System, Emergency Room Visits, Psychiatric Hospitalizations, Community Housing, Homelessness, Negative Disenrollments, Positive Disenrollments, Staff Stability, and File Reviews.
Jail Diversion Program in Polk County
The Jail Diversion Program has been in place in Polk County Jail for over a decade with the goal of helping the jail's population with serious mental illness to return to the community safely and to reduce the chances they will reoffend in the future. However, the county has not fully explored the data they have collected over the years to understand the factors that relate to the program's effectiveness or the challenges that might limit the program's effectiveness. The purpose of this research is to use data that are currently available to investigate the factors that lead to desired outcomes or create challenges to the success of the program. This project was funded by the Nellie Ball Trust Research Fund.
Informed Consent Research
Informed consent is effective only if individuals are presented with the relevant, legally required information about the research study and understand that information sufficiently to make an informed decision.
Interactive Multimedia and Biorepository Informed Consent Study
This study is intended to demonstrate the feasibility of integrating interactivity and multimedia to efficiently enhance and standardize the informed consent process for human DNA and tissue biorepositories. We expected a combined intervention of interactivity and multimedia to significantly improve subject knowledge and understanding and trust and to decrease staff time devoted to obtaining consent, when compared to a standard, paper-based informed consent process (e.g., control group). The study was conducted at three sites across the country in Chicago, Illinois, Atlanta, Georgia, and Bronx, New York, with collaborators at Northwestern University, Emory University, and the Montefiore Medical/Albert Einstein College of Medicine. Funded by a grant from the National Human Genome Institute at the National Institutes of Health (R01HG008348).
Publication:
Simon, C. M., Wang, K., Shinkunas, L. A., Stein, D. T., Meissner, P., Smith, M., Pentz, R., Klein, D. W. (2021). Communicating with diverse patients about participating in a biobank: A randomized multisite study comparing electronic and face-to-face informed consent processes. Journal of Empirical Research on Human Research Ethics, 17(1-2):144-166. doi:10.1177/15562646211038819
Interactive, Multimedia Informed Consent for Clinical Trials
This pilot study intended to identify ways to improve informed consent processes for research by incorporating instructional design strategies that use multimedia and interactivity. We hypothesized that providing information in multiple media, managing the sequence and rate of presentation of information, and making the informed consent process interactive would result in improved participant understanding. Funded by a grant from the National Human Genome Institute at the National Institutes of Health (R21HG006293).
Publications:
Simon, C. M., Klein, D. W., & Schartz, H. A. (2015). Interactive multimedia consent for biobanking: a randomized trial. Genet Med, 18(1), 57-64. doi:10.1038/gim.2015.33.
Simon, C. M., Klein, D. W., & Schartz, H. A. (2016). Digitizing consent: The Food and Drug Administration’s Draft Guidance on electronic informed consent. IRB Ethics & Human Research, 38(5), 15-18. Retrieved from http://www.thehastingscenter.org/irb_article/digitizing-consent-food-drug-administrations-draft-guidance-electronic-informed-consent/.
Electronic consent in the VA research system: a proof-of-concept study
Research with VA patients frequently requires informed consent. When informed consent is conducted face-to-face, by telephone or through the mail, it can be time-consuming and resource-intensive for researchers, and participants may be prone to misunderstanding the information presented. For VA researchers, an interactive, multimedia process can contribute to more efficient recruitment and a more reliable means of educating patients on the core elements of research participation. For VA patients, particularly those in rural areas with limited access to a VA center but who have access to the Internet, electronically accessing information about a research study may not only improve their understanding of that study, but also their access to and satisfaction with the overall consent process for a research study. The objective of the research was to develop a prototype interactive, multimedia consent and to identify the potential barriers and benefits to implementation of such a system at the VA with feedback from VA patients and stakeholders.
This project was funded by the U.S. Department of Veterans Affairs, Center for Comprehensive Access & Delivery Research and Evaluation (PIs: Simon, Schartz, & Klein), “Electronic consent for rural VA patients: A pilot project” and the National Center for Complementary and Alternative Medicine, National Institutes of Health (PI: Rosenthal), “Nighttime dosing of anti-hypertensive medications: A pragmatic clinical trial” (UH2AT00784).
Publication:
Simon, C. M., Schartz, H. A., Rosenthal, G. E., Eisenstein, E. L., & Klein, D. W. (2018). Perspectives on Electronic Informed Consent From Patients Underrepresented in Research in the United States: A Focus Group Study. Journal of Empirical Research on Human Research Ethics, 13(4), 338-348. doi:10.1177/1556264618773883.
An Interactive Multimedia Informed Consent Process for Medical Research
After developing an interactive, multimedia informed consent module based on principles of human learning, perception, and memory, this project investigated the feasibility of an interactive multimedia informed consent process that can optimize learning of information presented in informed consent to meet both the spirit and the content of the legal requirements under the federal regulations.