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Clinical Trial Summary

The goal of this study is to explore facilitators of and barriers to medication adherence within the context of local social determinants of health (SDOH) that are not available in the EHR. for American Indians with type 2 diabetes. The main aim is: Identify facilitators of and barriers to medication adherence within the context of SDOH, Electronic Health Record (EHR) derived medication adherence [HbA1c < 7 (at target); HbA1c >7% to ≤9% (above target); and HbA1c > 9% (uncontrolled)].


Clinical Trial Description

The investigators will identify potential participants by drawing a sub sample of 90 patients from the larger sample (based on findings from aims 1 and 2). Once patients are identified University of Florida (UF) study team members will provide a coded list of eligible patients, from the limited dataset, to the Choctaw Nation of Oklahoma (CNO) Information Management team. The CNO Information Management team will provide the contact information for 135 individuals directly to the CNO community health worker who will then contact patients. UF study team members will not have access to the identifiable data. The CNO community health worker (not UF study team members) will contact by telephone or in person at a scheduled visit the identified patients within each of the sampling groups (labeled 1-6) to introduce the study and screen for eligibility. After reviewing the consent, answering any questions, and obtaining written consent for the study, the CNO community health worker will use a structured interview guide containing semi-structured and open-ended questions with probes to collect in-depth information from the patient. As part of the interview session patients will be asked to complete 3 sets of questionnaire items: demographic, SDOH, and medication and utilization. All interviews will be audio recorded and professionally transcribed and validated for accuracy. Instead of using patient names CNO will link each transcript back to the code number provided by the UF study team. The UF study team will not have access to the link of the code number to the patient identifier. The de-identified transcripts will be sent to UF Study team members for analysis. A UF study team member will use a qualitative data management program to aid in analyzing and managing the data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06053359
Study type Observational
Source University of Florida
Contact
Status Withdrawn
Phase
Start date April 2024
Completion date June 2026

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