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

NCT ID: NCT04376112

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2021-01-01

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).

Conditions

Diabetes; Medication Non Adherence; Blood Pressure; Pharmacist-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

None. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months

Pharmacist Intervention

Group Type: EXPERIMENTAL

Pharmacist and pillpack intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Standard of care

None. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loma Linda University Pharmacy at SACHS

San Bernardino, California, United States

Countries

United States

Other Identifiers

5190360

Identifier Type: -

Identifier Source: org_study_id