DiabetesNCT05995262
Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons with Diabetes
An observational study of Diabetes and Type2diabetes, run by Methodist Health System at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes, Type2diabetes
- What is being tested?
- Chart Review
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2023to 3 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75237
About this study
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.
Read the detailed 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.
- Conditions
- Diabetes, Type2diabetes
- Being tested
- Chart Review
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chart ReviewOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c levels
HbA1c will be evaluated within 90 days prior to the first visit and within 90 days after the last clinic encounter.
Measured: within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start6 Apr 2023
- Primary completionApr 2025 (estimated)
- Study completion3 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Proffitt, PharmD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995262
- Sponsor's protocol ID
- 115.PHA.2022.C
- Status last verified
- Sep 2024
- First submitted
- 9 Aug 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons with Diabetes
- ClinicalTrials.gov ID
- NCT05995262
- Acronym / sponsor ID
- 115.PHA.2022.C
- Conditions
- Diabetes, Type2diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- 3 Apr 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HbA1c | – | Other: Chart ReviewMinimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chart ReviewData 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 | Other | HbA1c |
Primary outcome
HbA1c levels
Time frame: within 90 days
HbA1c will be evaluated within 90 days prior to the first visit and within 90 days after the last clinic encounter.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Proffitt, PharmD principal investigator
Methodist Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Type2diabetes, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c levels (time frame: within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.