xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05995262</url>
    </required_header>
    <id_info>
      <org_study_id>115.PHA.2022.C</org_study_id>
      <nct_id>NCT05995262</nct_id>
    </id_info>
    <brief_title>Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons With Diabetes</brief_title>
    <official_title>Effect of a Pharmacist-led, Collaborative Practice on Clinical Outcomes in Persons With Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Methodist Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Methodist Health System</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Diabetes is a complex chronic illness known for its high prevalence (11.3% in the United&#xD;
        States), significant healthcare burdens in terms of cost and management, and high mortality&#xD;
        rate (seventh leading cause of death in the United States in 2019). Diabetes-related&#xD;
        complications including ischemic heart disease, stroke, hyperglycemic crises, amputations,&#xD;
        and hypoglycemia accounted for 8.25 million hospital discharges and 25.9% of emergency&#xD;
        department visits, contributing towards the $327 billion total cost of diabetes in 2017.&#xD;
        Proper treatment of diabetes is integral to reduce a patient's risk of developing&#xD;
        complications; however, a number of barriers can create additional burdens for persons with&#xD;
        diabetes.&#xD;
  &#xD;
        Several studies have also demonstrated reductions in hospitalizations and/or ED visits for&#xD;
        patients enrolled in pharmacist-led collaborative practice models. While the literature as a&#xD;
        whole clearly describes the impact of ambulatory pharmacist intervention in achieving&#xD;
        guideline-based clinical goals (i.e., HbA1c, blood pressure), few studies have reported on&#xD;
        adherence with guideline-driven pharmacotherapy pre- and post-pharmacist intervention, or on&#xD;
        pharmacist impact in reducing medication burden.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Diabetes is a complex chronic illness known for its high prevalence (11.3% in the United&#xD;
        States), significant healthcare burdens in terms of cost and management, and high mortality&#xD;
        rate (seventh leading cause of death in the United States in 2019). Diabetes-related&#xD;
        complications including ischemic heart disease, stroke, hyperglycemic crises, amputations,&#xD;
        and hypoglycemia accounted for 8.25 million hospital discharges and 25.9% of emergency&#xD;
        department (ED) visits, contributing towards the $327 billion total cost of diabetes in 2017.&#xD;
        Proper treatment of diabetes is integral to reduce a patient's risk of developing&#xD;
        complications; however, a number of barriers can create additional burdens for persons with&#xD;
        diabetes (PWD). The root of these barriers affecting diabetes care is a topic of significant&#xD;
        discussion especially given the emergence of conversations surrounding social determinants of&#xD;
        health (SDOH) in recent years. A 2019 article from Annual Review of Public Health suggests&#xD;
        that PWD experience health disparity, which are preventable differences in quality of&#xD;
        healthcare and outcomes. This article discusses that health disparity is largely due to SDOH&#xD;
        which are defined as the economic, environmental, political, and social conditions in which&#xD;
        people live. Unfortunately, published research thus far has not identified strategies to&#xD;
        reduce diabetes-related health inequity across the entire population. When providers&#xD;
        recognize and discuss non-medical factors that influence PWD's health outcomes (e.g., food&#xD;
        security, housing stability, transportation access, and financial security), they are able to&#xD;
        promote health equity within their practice. Realistically, many providers have limited time&#xD;
        to devote to individual patient encounters which often focus on immediate medical issues and&#xD;
        eclipse discussions of non-medical issues, pharmacotherapy, and lifestyle changes. Thus,&#xD;
        multidisciplinary care teams, including dieticians, nurses, and pharmacists, are recommended&#xD;
        by the American Diabetes Association's (ADA) Standard of Care in Diabetes to ensure PWD&#xD;
        receive the comprehensive care they need.&#xD;
  &#xD;
        Within these teams, ambulatory care pharmacists are uniquely equipped to utilize their strong&#xD;
        background in pharmacotherapy to provide chronic disease state medication management services&#xD;
        for core primary care disease states, such as diabetes, hypertension, and hyperlipidemia. In&#xD;
        many settings, ambulatory care pharmacists work under collaborative practice agreements&#xD;
        (CPA), which are legal arrangements between pharmacists and physicians that allow for&#xD;
        expanded services. The additional abilities granted within CPAs allow clinical pharmacists to&#xD;
        assume professional responsibility by performing patient assessments, counseling, and&#xD;
        referrals; ordering laboratory tests; administering drugs; and selecting, initiating,&#xD;
        monitoring, continuing, and adjusting drug regimens. By allowing pharmacists to take on this&#xD;
        prescribing role within a multidisciplinary team, patients receive more individualized,&#xD;
        patient-centered care as recommended by ADA's Standard of Care in Diabetes and there is&#xD;
        reduced clinical inertia (i.e., lack of treatment intensification in a patient not at&#xD;
        evidence-based goals for care). In fact, patients receiving care from pharmacists under CPA&#xD;
        were shown to have significantly better outcomes compared to patients receiving &quot;usual care&quot;&#xD;
        without pharmacist intervention. Studies in a variety of ambulatory settings have illustrated&#xD;
        that pharmacist intervention can significantly improve clinical outcomes in terms of&#xD;
        hemoglobin A1C (HbA1c) level, blood pressure control, lipid panels, and body mass index. One&#xD;
        study of a pharmacist-driven type 2 diabetes mellitus (T2DM)-targeted collaborative practice&#xD;
        in an urban underserved clinic demonstrated significant improvements not only in HbA1c and&#xD;
        tobacco cessation but also in guideline recommended utilization of statins and&#xD;
        angiotensin-converting enzyme inhibitor/angiotensin receptor blockers. Several studies have&#xD;
        also demonstrated reductions in hospitalizations and/or ED visits for patients enrolled in&#xD;
        pharmacist-led collaborative practice models. While the literature as a whole clearly&#xD;
        describes the impact of ambulatory pharmacist intervention in achieving guideline-based&#xD;
        clinical goals (i.e., HbA1c, blood pressure), few studies have reported on adherence with&#xD;
        guideline-driven pharmacotherapy pre- and post-pharmacist intervention, or on pharmacist&#xD;
        impact in reducing medication burden.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">April 6, 2023</start_date>
    <completion_date type="Anticipated">April 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c levels</measure>
      <time_frame>within 90 days</time_frame>
      <description>HbA1c will be evaluated within 90 days prior to the first visit and within 90 days after the last clinic encounter.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Diabetes</condition>
    <condition>Type2diabetes</condition>
    <arm_group>
      <arm_group_label>HbA1c</arm_group_label>
      <description>Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chart Review</intervention_name>
      <description>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</description>
      <arm_group_label>HbA1c</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading&#xD;
          within 90 days after the last clinic encounter&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt; 18 years old&#xD;
  &#xD;
            -  Minimum of two visits with clinical pharmacist during 2022&#xD;
  &#xD;
            -  Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c&#xD;
               reading within 90 days after the last clinic encounter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Clinic patients without diagnosis of type 1 diabetes mellitus or T2DM which, per ADA&#xD;
               2022 Standards of Care, is defined as an HbA1c of &gt;6.5%&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Melanie Proffitt, PharmD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Methodist Health System</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Methodist Dallas Medical Center</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75237</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05995262
  org study id: 115.PHA.2022.C
  nct id: NCT05995262
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Retrospective
  measure: HbA1c levels
  time frame: within 90 days
  description: HbA1c will be evaluated within 90 days prior to the first visit and within 90 days after the last clinic encounter.
  arm group label: HbA1c
  description: Minimum of one HbA1c reading within 90 days prior to first visit AND one HgbA1c reading within 90 days after the last clinic encounter
  intervention type: Other
  intervention name: Chart Review
  description: 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
  arm group label: HbA1c
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  last name: Melanie Proffitt, PharmD
  role: Principal Investigator
  affiliation: Methodist Health System
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  sharing ipd: No