Clinical trial NCT06053359: Medication Use Among American Indians Adults
Official title: Understanding Medication Use Among Adult American Indians: Aim 3
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 2 Diabetes
Medication Adherence
Keywords: Type 2 diabetes
Medication Adherence
American Indians
Barriers
Facilitators
Social Determinants of Health
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: American Indians living on Choctaw Nation's 10.5 county service area who have type 2 diabetes

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 \[HbA1c \< 7 (at target); HbA1c \>7% to ≤9% (above target); and HbA1c \> 9% (uncontrolled)\].

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

(1) has end-stage renal disease

Primary outcomes:
measure: Semi-structured and Open-Ended Interview Questions
timeFrame: 1 day
Secondary outcomes:
measure: Demographic Questionnaire
timeFrame: 1 day
measure: Social Determinants of Health Questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: