Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons with Diabetes

NCT05995262 | Active Not Recruiting

• 1 other identifier: 115.PHA.2022.C
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetes is a complex chronic illness known for its high prevalence (11.3% in the United States), significant healthcare burdens in terms of cost and management, and high mortality rate (seventh leading cause of death in the United States in 2019). Diabetes-related complications including ischemic heart disease, stroke, hyperglycemic crises, amputations, and hypoglycemia accounted for 8.25 million hospital discharges and 25.9% of emergency department visits, contributing towards the $327 billion total cost of diabetes in 2017. Proper treatment of diabetes is integral to reduce a patient's risk of developing complications; however, a number of barriers can create additional burdens for persons with diabetes. Several studies have also demonstrated reductions in hospitalizations and/or ED visits for patients enrolled in pharmacist-led collaborative practice models. While the literature as a whole clearly describes the impact of ambulatory pharmacist intervention in achieving guideline-based clinical goals (i.e., HbA1c, blood pressure), few studies have reported on adherence with guideline-driven pharmacotherapy pre- and post-pharmacist intervention, or on pharmacist impact in reducing medication burden.

Conditions

Diabetes; Type2diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c levels

  HbA1c will be evaluated within 90 days prior to the first visit and within 90 days after the last clinic encounter.

  within 90 days

Study Arms (1)

HbA1c

Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter

Other: Chart Review

Interventions

Chart Review OTHER

Data collection via retrospective chart review of patients from the Cedar Hill Clinic who had at least two visits with the clinical pharmacist between January 5, 2022 through December 31, 2022

HbA1c

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter

You may qualify if:

• Adults \> 18 years old
• Minimum of two visits with clinical pharmacist during 2022
• Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter

You may not qualify if:

• Clinic patients without diagnosis of type 1 diabetes mellitus or T2DM which, per ADA 2022 Standards of Care, is defined as an HbA1c of \>6.5%

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75237, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Melanie Proffitt, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: April 6, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 3, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)