Principal Investigator: Olayinka O Shiyanbola, PhD, B.Pharm, Assistant Professor
Department: University of Wisconsin Madison – School of Pharmacy
DFMCH sponsor: WREN research coordination under the supervision of Dr. David Hahn
Contact Person: Deanne Boss (DFMCH) firstname.lastname@example.org
Study Summary: This is a collaborative project with the University of Wisconsin Madison – School of Pharmacy. The purpose is to examine how medication adherence changes over time in Blacks/African Americans diagnosed with Type 2 Diabetes, and identify reasons for changes in medication adherence. These data will be used for developing future diabetes medication adherence interventions.
- For Blacks/African Americans diagnosed with Type 2 Diabetes, what contributes to medication adherence over time?
- Do psychosocial and interpersonal factors play a role on changes in adherence to medication?
Eligibility and Exclusion of Recruitment: UW Family Medicine Patients will be eligible if they are English speaking, self-identifying as Black/African Americans over the age of 20, diagnosed with type 2 diabetes, and prescribed at least one oral daily diabetes medicine. Patients with a history of cancer, dementia or other life-threatening conditions, or who are otherwise unable to complete questionnaires are ineligible. All eligible patients, estimated at 2,000, will be contacted with an aim to achieve 200 respondents.
Selection and Contact Methods: Phase 1 – Eligible patients will be selected from the UW Health Electronic Health Records, using the ServiceNow data request mechanism. Patients will be contacted by mail with phone reminders. Per the inclusion/exclusion criteria, a recruitment letter, informed consent, $2 prepaid cash incentive, the study survey, and a self-addressed stamped return envelope, will be sent in a sealed envelope to study identified participants. Those individuals who return the completed survey will be sent a $10 gift card afterwards in a sealed envelope. For those study participants who did not return the survey, three follow-up phone calls will be made, with an intended goal of 200 completed surveys. The completed surveys will be entered into a secure REDCap database (housed at ICTR). Six months later, this process will be repeated with a $5 prepaid cash incentive sent with a follow-up survey and a self-addressed stamped envelope. Phase 2 – conduct a 60 minute interview with twenty participants who complete both surveys. The interviews will discuss the factors that predicted a change in adherence outcomes.
IRB: UW Minimal Risk IRB granted PI’s exemption request through protocol review.
Assurance of HIPAA Privacy Compliance: PI and Staff HIPAA attestations are completed. Patient facing materials, correspondence, and contact methods have been reviewed and edited for compliance.
Impact on Clinics: Minimal. There is no direct effect on operations. All patient interactions are off-site, through the US mail and through phone reminder contacts.
DFMCH Mission Alignment: Compared to non-Hispanic Whites, Blacks/African Americans have a two-fold greater diabetes risk, a 25% lower medication adherence, and are five times more likely to develop diabetic complications. Project aligns with Department’s mission to eliminate health disparities by improving patient care and community health.
Reporting: So that the Department can broadly disseminate findings, the applicant agrees to report all project results, including abstracts, presentations, manuscripts, etc.
Date of Approval: February 23, 2018