Medication Use Among American Indians Adults

Sponsor

University of Florida (Other)

Overall Status

Withdrawn

CT.gov ID

NCT06053359

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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)].

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Medication Adherence

Detailed 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

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Understanding Medication Use Among Adult American Indians: Aim 3

Anticipated Study Start Date :

Apr 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Jun 1, 2026

Outcome Measures

Primary Outcome Measures

Semi-structured and Open-Ended Interview Questions [1 day]
We will use a semi-structured interview guide that is structured based on medication adher

Secondary Outcome Measures

Demographic Questionnaire [1 day]
Each patient will be asked to fill out a questionnaire regarding their demographic information (e.g., age, sex, income, education).
Social Determinants of Health Questionnaire [1 day]
We will assess facilitators of and barriers to medication adherence within the context of SDOH using adaptation of validated questions from the Toolkit.7 Questions related to housing, transportation, miles to grocery store and tribal clinic, involvement with CNO cultural activities, use of CNO food distribution.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

enrolled tribal member
18 years and older
have been diagnosed with type 2 diabetes
live within CNOs 10.5 county service area
use CNO Tribal Health Services
for whom cardiometabolic levels and medication adherence level will have been generated from the aim 1 analysis of CNO data
willing and able to participant in a 60-90-minute interview focused on facilitators of and barriers to medication adherence.