Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05995262 |
| Other study ID # |
115.PHA.2022.C |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 6, 2023 |
| Est. completion date |
April 3, 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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 (ED) 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 (PWD). The root of these barriers affecting diabetes care is a topic of significant
discussion especially given the emergence of conversations surrounding social determinants of
health (SDOH) in recent years. A 2019 article from Annual Review of Public Health suggests
that PWD experience health disparity, which are preventable differences in quality of
healthcare and outcomes. This article discusses that health disparity is largely due to SDOH
which are defined as the economic, environmental, political, and social conditions in which
people live. Unfortunately, published research thus far has not identified strategies to
reduce diabetes-related health inequity across the entire population. When providers
recognize and discuss non-medical factors that influence PWD's health outcomes (e.g., food
security, housing stability, transportation access, and financial security), they are able to
promote health equity within their practice. Realistically, many providers have limited time
to devote to individual patient encounters which often focus on immediate medical issues and
eclipse discussions of non-medical issues, pharmacotherapy, and lifestyle changes. Thus,
multidisciplinary care teams, including dieticians, nurses, and pharmacists, are recommended
by the American Diabetes Association's (ADA) Standard of Care in Diabetes to ensure PWD
receive the comprehensive care they need.
Within these teams, ambulatory care pharmacists are uniquely equipped to utilize their strong
background in pharmacotherapy to provide chronic disease state medication management services
for core primary care disease states, such as diabetes, hypertension, and hyperlipidemia. In
many settings, ambulatory care pharmacists work under collaborative practice agreements
(CPA), which are legal arrangements between pharmacists and physicians that allow for
expanded services. The additional abilities granted within CPAs allow clinical pharmacists to
assume professional responsibility by performing patient assessments, counseling, and
referrals; ordering laboratory tests; administering drugs; and selecting, initiating,
monitoring, continuing, and adjusting drug regimens. By allowing pharmacists to take on this
prescribing role within a multidisciplinary team, patients receive more individualized,
patient-centered care as recommended by ADA's Standard of Care in Diabetes and there is
reduced clinical inertia (i.e., lack of treatment intensification in a patient not at
evidence-based goals for care). In fact, patients receiving care from pharmacists under CPA
were shown to have significantly better outcomes compared to patients receiving "usual care"
without pharmacist intervention. Studies in a variety of ambulatory settings have illustrated
that pharmacist intervention can significantly improve clinical outcomes in terms of
hemoglobin A1C (HbA1c) level, blood pressure control, lipid panels, and body mass index. One
study of a pharmacist-driven type 2 diabetes mellitus (T2DM)-targeted collaborative practice
in an urban underserved clinic demonstrated significant improvements not only in HbA1c and
tobacco cessation but also in guideline recommended utilization of statins and
angiotensin-converting enzyme inhibitor/angiotensin receptor blockers. 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.
