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/NCT06015685</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00006033</org_study_id>
      <nct_id>NCT06015685</nct_id>
    </id_info>
    <brief_title>Embedded Primary Care MultiDisciplinary Diabetes Clinic</brief_title>
    <official_title>Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Emory University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Georgia Center for Diabetes Translation Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Emory University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to improve diabetes management for patients at Midtown General&#xD;
        Internal Medicine Clinic (Aim 1). The clinic offers dedicated diabetes care on certain days&#xD;
        with trained providers able to offer dedicated diabetes care. The clinic will also make sure&#xD;
        to address other aspects of life and health that may impact an individual's ability to manage&#xD;
        their diabetes - food insecurity, housing insecurity, knowing about healthy food, finding&#xD;
        ways to exercise, and mental health. The study will also train the medical residents to be&#xD;
        able to participate in this dedicated diabetes care (Aim 2).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There is a widening quality of care gap in diabetes mellitus (DM) management that sees Black&#xD;
        and Hispanic patients with much higher rates of DM complications and hospitalizations&#xD;
        compared to their white counterparts. Primary Care is the frontline for DM prevention and&#xD;
        management; however, Primary Care Clinics, including Internal Medicine resident continuity&#xD;
        clinics, struggle to improve DM metrics. The lack of resources, such as time and personnel,&#xD;
        is a significant limiting factor in strategies that would allow these clinics to optimize&#xD;
        care. As a result, the current DM management model was created, in which Primary Care&#xD;
        providers refer patients with elevated hemoglobin A1c (HbA1c) to subspecialty care. This&#xD;
        process is inefficient, overwhelms subspecialty practices, and most importantly does not&#xD;
        address the social determinants of health that often make it difficult for patients to get&#xD;
        their DM under control.&#xD;
  &#xD;
        This traditional model also comes with a potential institutional financial cost. There is a&#xD;
        perception that reducing upfront costs of care can make a system more economically viable;&#xD;
        yet this can have devastating results for a system and for its patients on the back end. For&#xD;
        example, HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a&#xD;
        patient population is not supported in their efforts for DM control, this can translate to&#xD;
        monetary loss annually for the Emory Healthcare System. In addition, there are also potential&#xD;
        losses to the system related to long-term morbidity and mortality risks of elevated HbA1c&#xD;
        over time.&#xD;
  &#xD;
        Studies have shown that a multi-disciplinary approach including physician, dietitian, DM&#xD;
        education, psychotherapy, and social work services functioning concurrently and cooperatively&#xD;
        has the potential to positively change the current paradigm. Given the vital role Primary&#xD;
        Care plays in the management of all aspects of patient care, including physical and&#xD;
        psychosocial well-being, this care delivery model is optimally designed to have the most&#xD;
        impact and success in the Primary Care Clinic setting. The research team proposes to embed a&#xD;
        multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System&#xD;
        where this approach would create a central location for all the patients' DM needs, provide&#xD;
        efficient care that helps patients address social and economic barriers, and engage the care&#xD;
        team through between-clinic touchpoints to motivate patients to take agency over their&#xD;
        health. This also provides a venue to implement modern technologies for DM management, such&#xD;
        as continuous glucose monitoring (CGM). Despite its proven efficacy in DM management, CGM&#xD;
        remains an understudied intervention in Primary Care, especially in patient populations that&#xD;
        would otherwise have difficulty accessing specialty care. Researchers anticipate that these&#xD;
        changes will enable improved adherence to follow-up visits and treatment.&#xD;
  &#xD;
        In addition to the benefits of streamlined patient care, this model also offers the&#xD;
        opportunity to enhance Internal Medicine residency education. Investigators intend to develop&#xD;
        a hybrid clinical/educational curriculum for residents that capitalizes on and models&#xD;
        appropriate resource utilization through an integrated care model and provides early exposure&#xD;
        to multi-disciplinary care and CGM.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the proportion of embedded clinic patients with an HbA1c &gt;9%</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>Percentage of participants with HbA1c &gt;9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in acceptability of intervention measure (AIM)</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>AIM score is a four-item measures of implementation outcomes that are often considered &quot;leading indicators&quot; of implementation success (likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the acceptability of model implementation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in feasibility of intervention measure (FIM) scores</measure>
      <time_frame>Baseline and 6 months</time_frame>
      <description>FIM score is a four-item measures of implementation outcomes that are often considered &quot;leading indicators&quot; of implementation success likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the feasibility of model implementation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in weight</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Change in weight will be assessed from available measurements in EMR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in body mass index (BMI)</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>BMI will be calculated from available measurements in EMR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in diabetes self-efficacy score</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Participants will complete the diabetes management self-efficacy scale (DMSES). It assesses the extent to which respondents are confident they can manage their blood sugar, diet, and level of exercise. Responses are rated on a 5-point scale ranging from ''can't do at all'' to ''certain can do'' (1, 5). In this scale, higher scores indicate higher self-efficacy in performing Diabetes self-management (DSM) activities.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in depression status</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>The 9-question Patient Health Questionnaire (PHQ9) is a diagnostic tool to screen adult patients in a primary care setting for the presence and severity of depression. Scores represent: 0-5 = mild 6-10 = moderate 11-15 = moderately severe. 16-20 = severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the patient-reported quality of life score</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) survey. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in anxiety score</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in food insecurity</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Participants will complete the Latin American and Caribbean (ELSCA) Household Food Security Measurement Scale. This scale uses a set of 15 questions, with yes/no response categories, seven of which are for households with children. Each question asks the respondent whether he/she or any other household member has experienced a certain manifestation of food insecurity in the previous three months. Households that affirm 3 items are classified as food insecure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Housing Insecurity</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Percentage of participants of being at risk for housing insecurity by answering the 2-question housing insecurity instrument: (1) &quot;Are you worried or concerned that in the next 2 months you may not have stable housing that you own, rent, or stay in as part of a household?&quot; with responses of &quot;yes&quot; or &quot;no,&quot; and (2) &quot;How likely do you think it would be that you would have to use a homeless shelter in the next 6 months?&quot; with 4 response options ranging from &quot;very unlikely&quot; to &quot;very likely.&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in urine microalbumin</measure>
      <time_frame>Baseline, 3 months, and 6 months</time_frame>
      <description>Change in urine microalbumin (mcg/mg min 0 and higher the worse the outcome) will be calculated from available laboratory assessments from EMR</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Embedded clinic at Midtown</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Using the Emory Clinical Data Warehouse (CDW), all patients of Emory Primary Care Midtown with HbA1c &gt;9% who are not currently under the care of an endocrinologist or the diabetes management program at Emory will be invited to participate in this embedded DM management clinic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine Care- Dunwoody Family Medicine Clinic</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>The control population will be drawn using electronic health record data of diabetes patients at Dunwoody Family Medicine Clinic. Information from the Electronic Health Record will be de-identified after extraction. Control participants will be frequency matched.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Embedded Clinic</intervention_name>
      <description>Once a week, a Primary Care clinic half-day will be dedicated to multi-disciplinary, team-based DM care. The inter-professional team will include an Internal Medicine attending physician, an Internal Medicine resident, a DM educator, a nurse trained in professional CGM, a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.</description>
      <arm_group_label>Embedded clinic at Midtown</arm_group_label>
      <other_name>multi-disciplinary, team-based DM care</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Routine Care</intervention_name>
      <description>Researchers will use a 2:1 ratio of control to intervention patients. Using the CDW, researchers will identify a control population [patients who receive routine care (i.e., referral to subspecialty care)], who will be a propensity-matched cohort of individuals with similar age, gender, race/ethnicity, zip codes, insurance type, visit dates, and co-morbidities (Charlson Comorbidity Index) as the intervention group.</description>
      <arm_group_label>Routine Care- Dunwoody Family Medicine Clinic</arm_group_label>
      <other_name>Control Group</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Aim 1 (Embedded diabetes clinic):&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18+&#xD;
  &#xD;
            -  Patient at Midtown Diabetes Clinic&#xD;
  &#xD;
            -  Able to consent&#xD;
  &#xD;
            -  HbA1c &gt;=9%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not planning to follow up at Midtown&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Followed by Endocrinology as a specialist&#xD;
  &#xD;
          Aim 2 (Embedded diabetes clinic and curriculum):&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          - All residents in Midtown Primary Care are eligible&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Britt A Marshall, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Emory University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Britt A Marshall, MD</last_name>
      <phone>(404) 686-4411</phone>
      <email>britt.marshall@emory.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Emory Primary Clinic Care at Midtown</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30308</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Britt A. Marshall, MD</last_name>
        <phone>404-686-4411</phone>
        <email>britt.marshall@emory.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Emory University</investigator_affiliation>
      <investigator_full_name>Britt A. Marshall</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Primary Care</keyword>
    <keyword>Continuous Glucose Monitoring (CGM)</keyword>
    <keyword>Diabetes Management</keyword>
    <keyword>Multidisciplinary care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The research team will share deidentified individual participant's data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>The research team will share the deidentified data immediately following publication, with no known end date.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims specified in their proposal&#xD;
  All proposals should be sent to britt.marshall@emory.edu.</ipd_access_criteria>
    </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/NCT06015685
  org study id: STUDY00006033
  nct id: NCT06015685
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to improve diabetes management for patients at Midtown General
        Internal Medicine Clinic (Aim 1). The clinic offers dedicated diabetes care on certain days
        with trained providers able to offer dedicated diabetes care. The clinic will also make sure
        to address other aspects of life and health that may impact an individual's ability to manage
        their diabetes - food insecurity, housing insecurity, knowing about healthy food, finding
        ways to exercise, and mental health. The study will also train the medical residents to be
        able to participate in this dedicated diabetes care (Aim 2).
  There is a widening quality of care gap in diabetes mellitus (DM) management that sees Black
        and Hispanic patients with much higher rates of DM complications and hospitalizations
        compared to their white counterparts. Primary Care is the frontline for DM prevention and
        management; however, Primary Care Clinics, including Internal Medicine resident continuity
        clinics, struggle to improve DM metrics. The lack of resources, such as time and personnel,
        is a significant limiting factor in strategies that would allow these clinics to optimize
        care. As a result, the current DM management model was created, in which Primary Care
        providers refer patients with elevated hemoglobin A1c (HbA1c) to subspecialty care. This
        process is inefficient, overwhelms subspecialty practices, and most importantly does not
        address the social determinants of health that often make it difficult for patients to get
        their DM under control.
  
        This traditional model also comes with a potential institutional financial cost. There is a
        perception that reducing upfront costs of care can make a system more economically viable;
        yet this can have devastating results for a system and for its patients on the back end. For
        example, HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a
        patient population is not supported in their efforts for DM control, this can translate to
        monetary loss annually for the Emory Healthcare System. In addition, there are also potential
        losses to the system related to long-term morbidity and mortality risks of elevated HbA1c
        over time.
  
        Studies have shown that a multi-disciplinary approach including physician, dietitian, DM
        education, psychotherapy, and social work services functioning concurrently and cooperatively
        has the potential to positively change the current paradigm. Given the vital role Primary
        Care plays in the management of all aspects of patient care, including physical and
        psychosocial well-being, this care delivery model is optimally designed to have the most
        impact and success in the Primary Care Clinic setting. The research team proposes to embed a
        multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System
        where this approach would create a central location for all the patients' DM needs, provide
        efficient care that helps patients address social and economic barriers, and engage the care
        team through between-clinic touchpoints to motivate patients to take agency over their
        health. This also provides a venue to implement modern technologies for DM management, such
        as continuous glucose monitoring (CGM). Despite its proven efficacy in DM management, CGM
        remains an understudied intervention in Primary Care, especially in patient populations that
        would otherwise have difficulty accessing specialty care. Researchers anticipate that these
        changes will enable improved adherence to follow-up visits and treatment.
  
        In addition to the benefits of streamlined patient care, this model also offers the
        opportunity to enhance Internal Medicine residency education. Investigators intend to develop
        a hybrid clinical/educational curriculum for residents that capitalizes on and models
        appropriate resource utilization through an integrated care model and provides early exposure
        to multi-disciplinary care and CGM.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Change in the proportion of embedded clinic patients with an HbA1c >9%
  time frame: Baseline and 6 months
  description: Percentage of participants with HbA1c >9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)
  measure: Change in acceptability of intervention measure (AIM)
  time frame: Baseline and 6 months
  description: AIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success (likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the acceptability of model implementation.
  measure: Change in feasibility of intervention measure (FIM) scores
  time frame: Baseline and 6 months
  description: FIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the feasibility of model implementation.
  measure: Change in weight
  time frame: Baseline, 3 months, and 6 months
  description: Change in weight will be assessed from available measurements in EMR.
  measure: Change in body mass index (BMI)
  time frame: Baseline, 3 months, and 6 months
  description: BMI will be calculated from available measurements in EMR
  measure: Change in diabetes self-efficacy score
  time frame: Baseline, 3 months, and 6 months
  description: Participants will complete the diabetes management self-efficacy scale (DMSES). It assesses the extent to which respondents are confident they can manage their blood sugar, diet, and level of exercise. Responses are rated on a 5-point scale ranging from ''can't do at all'' to ''certain can do'' (1, 5). In this scale, higher scores indicate higher self-efficacy in performing Diabetes self-management (DSM) activities.
  measure: Change in depression status
  time frame: Baseline, 3 months, and 6 months
  description: The 9-question Patient Health Questionnaire (PHQ9) is a diagnostic tool to screen adult patients in a primary care setting for the presence and severity of depression. Scores represent: 0-5 = mild 6-10 = moderate 11-15 = moderately severe. 16-20 = severe depression.
  measure: Change in the patient-reported quality of life score
  time frame: Baseline, 3 months, and 6 months
  description: Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) survey. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.
  measure: Change in anxiety score
  time frame: Baseline, 3 months, and 6 months
  description: Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety
  measure: Change in food insecurity
  time frame: Baseline, 3 months, and 6 months
  description: Participants will complete the Latin American and Caribbean (ELSCA) Household Food Security Measurement Scale. This scale uses a set of 15 questions, with yes/no response categories, seven of which are for households with children. Each question asks the respondent whether he/she or any other household member has experienced a certain manifestation of food insecurity in the previous three months. Households that affirm 3 items are classified as food insecure.
  measure: Change in Housing Insecurity
  time frame: Baseline, 3 months, and 6 months
  description: Percentage of participants of being at risk for housing insecurity by answering the 2-question housing insecurity instrument: (1) "Are you worried or concerned that in the next 2 months you may not have stable housing that you own, rent, or stay in as part of a household?" with responses of "yes" or "no," and (2) "How likely do you think it would be that you would have to use a homeless shelter in the next 6 months?" with 4 response options ranging from "very unlikely" to "very likely."
  measure: Change in urine microalbumin
  time frame: Baseline, 3 months, and 6 months
  description: Change in urine microalbumin (mcg/mg min 0 and higher the worse the outcome) will be calculated from available laboratory assessments from EMR
  arm group label: Embedded clinic at Midtown
  arm group type: Experimental
  description: Using the Emory Clinical Data Warehouse (CDW), all patients of Emory Primary Care Midtown with HbA1c >9% who are not currently under the care of an endocrinologist or the diabetes management program at Emory will be invited to participate in this embedded DM management clinic.
  arm group label: Routine Care- Dunwoody Family Medicine Clinic
  arm group type: Other
  description: The control population will be drawn using electronic health record data of diabetes patients at Dunwoody Family Medicine Clinic. Information from the Electronic Health Record will be de-identified after extraction. Control participants will be frequency matched.
  intervention type: Other
  intervention name: Embedded Clinic
  description: Once a week, a Primary Care clinic half-day will be dedicated to multi-disciplinary, team-based DM care. The inter-professional team will include an Internal Medicine attending physician, an Internal Medicine resident, a DM educator, a nurse trained in professional CGM, a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.
  arm group label: Embedded clinic at Midtown
  other name: multi-disciplinary, team-based DM care
  intervention type: Other
  intervention name: Routine Care
  description: Researchers will use a 2:1 ratio of control to intervention patients. Using the CDW, researchers will identify a control population [patients who receive routine care (i.e., referral to subspecialty care)], who will be a propensity-matched cohort of individuals with similar age, gender, race/ethnicity, zip codes, insurance type, visit dates, and co-morbidities (Charlson Comorbidity Index) as the intervention group.
  arm group label: Routine Care- Dunwoody Family Medicine Clinic
  other name: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Britt A Marshall, MD
  role: Principal Investigator
  affiliation: Emory University
  last name: Britt A Marshall, MD
  phone: (404) 686-4411
  email: britt.marshall@emory.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Emory University
  investigator full name: Britt A. Marshall
  investigator title: Assistant Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: The research team will share deidentified individual participant's data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices)
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: The research team will share the deidentified data immediately following publication, with no known end date.
  ipd access criteria: Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims specified in their proposal
  All proposals should be sent to britt.marshall@emory.edu.