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

NCT04376112 | Withdrawn

• 1 other identifier: 5190360
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• hemoglobin A1c

  Finger prick for HgA1c at baseline and at 6 months. Goal \< 7% normal above 7% is abnormal

  Change between baseline and 6 months

• blood pressure

  Blood pressure will be checked at baseline and at 6 months. Goal BP is 130/80 mmHg and above 130/80 mmHg is abnormal.

  Change between baseline and 6 months

• Medication adherence

  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.

  Change between baseline and 6 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Other: Standard of care

Pharmacist Intervention

EXPERIMENTAL

Other: Pharmacist and pillpack intervention

Interventions

Pharmacist and pillpack intervention 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.

Pharmacist Intervention

Standard of care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Pharmacy at SACHS

San Bernardino, California, 92410, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Medication Adherence

Interventions

Pharmacists; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: May 6, 2020
• Study Start: October 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

US (1)