Clinical trial NCT04376112: Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population
Official title: Influence of Pharmacist and Student Pharmacists on Medication Adherence in Community Pharmacy Setting in Underserved Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Medication Non Adherence
Blood Pressure
Pharmacist-Patient Relations
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: hemoglobin A1c
timeFrame: Change between baseline and 6 months
measure: blood pressure
timeFrame: Change between baseline and 6 months
measure: Medication adherence
timeFrame: Change between baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: Loma Linda University Pharmacy at SACHS
state: California
Study officials:
References: