Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population

Overview

The overall objective is to examine the influence of various services provided by the community pharmacy on patients' diabetes and diabetes-related health outcomes.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 1, 2021

Detailed Description

Diabetes affects approximately 30.3 million people in the U.S. and is the 7th leading cause of death (ADA 2019). Uncontrolled diabetes leads to various complications including cardiovascular disease, kidney disease, diabetic retinopathy, peripheral neuropathy, and lower extremity amputation. Estimated healthcare expenditure for individuals with diabetes is approximately $327 billion per year (ADA 2017). In San Bernardino County, the prevalence of diabetes was higher (12.4%) than the national rate (9.4%). More specifically, the federally qualified health center in which the Loma Linda University (LLU) community pharmacy serves has a diabetes prevalence rate of about 16% (HRSA 2017). To decrease risk of diabetes complications, HbA1c is recommended to be <7% in most patients; however, about 35% of the investigator's patient population have poorly controlled diabetes which is defined as HbA1c >9% (ADA 2019). Given high prevalence rates of uncontrolled diabetes in this high-risk population, it is pivotal that individuals are provided with appropriate diabetes self-management strategies, regular monitoring, and preventative care by their primary care provider to adequately control the disease. Numerous studies illustrate that clinical pharmacists improve health outcomes for chronic disease managements with medication therapy management (MTM) services in underserved patients. Additionally, team-based or coordinated care with the community pharmacist and the patient's health care providers has also demonstrated to assist with improvements in clinic outcomes of chronic diseases. Recently, combination of blister packaging and MTM services have been shown to improve medication adherence and clinical endpoints. Given the high prevalence of diabetes in this community, there is a critical need to achieve improvement in clinical diabetes outcomes possibly via monthly blister packaging and MTM services including point-of-care testing (POCT).

Interventions

  • Other: Pharmacist and pillpack intervention
    • These participants will be randomized into one of the following two cohorts: standard of care (SOC) and pharmacy intervention group (blister packaging + MTM services). For pharmacy intervention (PI) group, the POCT will be used to measure HbA1c and blood pressure (BP) at baseline, 3, and 6 months during medication therapy management (MTM) service. Recommendation from MTM services will be documented in the patients’ electronic medical records (EMRs) and shared with their primary care providers. For the SOC group, HbA1c and BP will be measured at the physician’s office and researchers will have an access to participants’ EMR.
  • Other: Standard of care
    • None. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months

Arms, Groups and Cohorts

  • Active Comparator: Standard of Care
  • Experimental: Pharmacist Intervention

Clinical Trial Outcome Measures

Primary Measures

  • hemoglobin A1c
    • Time Frame: Change between baseline and 6 months
    • Finger prick for HgA1c at baseline and at 6 months. Goal < 7% normal above 7% is abnormal
  • blood pressure
    • Time Frame: Change between baseline and 6 months
    • Blood pressure will be checked at baseline and at 6 months. Goal BP is 130/80 mmHg and above 130/80 mmHg is abnormal.
  • Medication adherence
    • Time Frame: Change between baseline and 6 months
    • Adherence of medication will be determined by patients picking up their medications. Patient profile will track every insurance claims for the medications. The proportion of days covered indicates the medication adherence, and it will be calculated at the end of 6 months.

Participating in This Clinical Trial

Inclusion Criteria

  • ≥18 years of age, any gender
  • Hemoglobin A1c >8.5%
  • Taking total of ≥5 medications and taking ≥2 anti-diabetes medications

Exclusion Criteria

  • Unable to give informed consent
  • Individuals included in Inland Empire Health Plan's Complex Care Program

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Loma Linda University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soo Min Jang, Assistant Professor – Loma Linda University
  • Overall Contact(s)
    • Soo Min Jang, PharmD, 9095587730, smjang@llu.edu

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