<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/NCT04461405</url>
  </required_header>
  <id_info>
    <org_study_id>20783</org_study_id>
    <nct_id>NCT04461405</nct_id>
  </id_info>
  <brief_title>INTEGRATE-D: A Pilot Test to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes</brief_title>
  <official_title>INTEGRATE-D: A Pilot Test of Implementation Strategies to Support Integration of Medical and Psychosocial Care for People With Type II Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</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>
      In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for&#xD;
      integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII)&#xD;
      and common mental and behavioral health (MH/BH) problems. In the United States, 30 million&#xD;
      people live with DMII, and the majority receive care in primary care settings. By&#xD;
      implementing the ADA recommendations, primary care practices will help patients better manage&#xD;
      their MH/BH needs, meet recommended goals for DMII management, and reduce the risk of adverse&#xD;
      outcomes. Making these recommendations a routine part of practice is a major change, and it&#xD;
      is critical to understand how best to implement the ADA recommendations and test its&#xD;
      effectiveness in the real world. The pilot study builds on a series of prior studies to&#xD;
      refine and pilot test a package of implementation strategies - called INTEGRATE-D - to&#xD;
      support practices in implementing the ADA recommendations for integrated DMII care.&#xD;
      INTEGRATE-D combines the following evidence-based implementation strategies: (1) electronic&#xD;
      health record (EHR)-based support - to help align EHR use with ADA recommendations and enable&#xD;
      screening for depression, anxiety, diabetes distress, cognitive impairment, and&#xD;
      self-management, and support identifying and tracking progress on patient treatments and&#xD;
      goals; (2) Audit and feedback - which involves assisting practices in accessing clinically&#xD;
      relevant, actionable data reports to inform measurement and identification of care gaps in&#xD;
      DMII and behavioral health care; (3) Skill-building resources - including training on&#xD;
      ADA-recommended care; and (4) Facilitation - to help implement the above strategies and&#xD;
      tailor the intervention so that practice work on the subset of areas where practices are&#xD;
      ready to change to align care with ADA recommendations. The study aims are Aim 1: Refine the&#xD;
      INTEGRATE-D intervention by incorporating the preferences of stakeholders. In partnership&#xD;
      with patients, primary care key stakeholders and experts, compile and refine the package of&#xD;
      implementation strategies in the INTEGRATE-D intervention. Aim 2: Demonstrate feasibility,&#xD;
      acceptability, and estimate cost. Conduct a mixed-method, pre-post pilot comparing two&#xD;
      practices that receive the INTEGRATE-D intervention to two control practices that receive&#xD;
      training materials only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The INTEGRATE-D intervention is designed to support primary care practices with implementing&#xD;
      ADA recommendations for integrating medical and psychosocial care for patients with DMII.&#xD;
      Primary care practices will be the recipients of this support. For practices, the&#xD;
      intervention will be 15 months long. The first three months will be a &quot;Readiness Phase&quot; where&#xD;
      the study team assesses practices' capacity at baseline and a facilitator works with&#xD;
      intervention practices to address capacity issues (e.g., help the practice produce a quality&#xD;
      report) that can be barriers during active implementation. Then, intervention practices&#xD;
      receive 12 months of &quot;Active Intervention&quot; with the same facilitator to align care processes&#xD;
      with ADA recommendations. Pilot study design: The study team will use a randomized,&#xD;
      mixed-method, pre-post design for this pilot study. The goal of this randomized pilot design&#xD;
      is to evaluate the feasibility of recruitment, randomization, retention, assessment&#xD;
      procedures, implementation of the INTEGRATE-D intervention, and provide insights into the&#xD;
      effect of this pilot intervention on practice-level outcomes. Practice Sample and eligibility&#xD;
      criteria: The sample for this pilot is four primary care practices. Practices with more than&#xD;
      100 adult patients (≥18 years) with a diagnosis of DM (Type II; not gestational) are&#xD;
      eligible. Practice Recruitment: Practices will be recruited from the ORPRN practice-based&#xD;
      research network. ORPRN works with 279 primary care practices in the state of Oregon,&#xD;
      including 51% that are rural and 42% clinician-owned practices. ORPRN recruiters will&#xD;
      identify 50 potential practices and conduct a faxback to assess interest, capacity, and&#xD;
      eligibility. Of interested practices, ORPRN and the study team will select 4 practices (2&#xD;
      rural and 2 non-rural) that vary on whether practices employ a behavioral health clinician.&#xD;
      The study team will purposefully vary practices on these characteristics based on previous&#xD;
      work that demonstrated they influenced intervention uptake. Patient Sample: The study team&#xD;
      will have three different patient samples. For chart audits, there will be two samples. (1)&#xD;
      Patients with a diagnosis of DMII who have been seen at least once at the practice in the 15&#xD;
      months prior to the intervention start date and at least once after the intervention start&#xD;
      date will be included in the chart audit. The study team will randomly select 50 patients&#xD;
      meeting these criteria. (2) Patients meeting the above criteria and screening positive for&#xD;
      depression (i.e., those patients who have minimally exposed to the INTEGRATE-D intervention&#xD;
      will also be randomly selected for chart audit. The study team will audit charts until there&#xD;
      is a sample of 30 patients meeting these criteria. (3) From this latter group, the study team&#xD;
      will select 5 patients at each of the two intervention practices to participate in an&#xD;
      interview. Randomization Procedure: Practices will be randomized in a 1:1 ratio through a&#xD;
      covariate-constrained randomization procedure. This is accomplished as follows. Prior to&#xD;
      randomization, the study team will collect baseline data on practice-level factors (e.g.,&#xD;
      practice size, ownership, rurality, patient panel demographics, etc.) that could influence&#xD;
      process and outcome measures. These data will be collected as part of the recruitment&#xD;
      process. The study team will construct all possible combinations of eligible practices into&#xD;
      two groups. For each selected possible randomization, the study team will compare the balance&#xD;
      between study arms in the important baseline data described above through a balance&#xD;
      criterion. The study team will randomly select one randomization combination (from the 2&#xD;
      combinations with the best balance) which will yield 2 practices in each study arm with good&#xD;
      balance in important covariates. Data Collection: For this pilot study, the study team will&#xD;
      collect mixed methods (survey, observation, interview, and chart audit) data. For control&#xD;
      practices, data collection will include the collection of survey and chart audit data. These&#xD;
      data will be collected at the same time as data collected from intervention practices.&#xD;
      Intervention practices, in addition to completing surveys and participating in the chart&#xD;
      audit, will participate in practice site visits, which include the study team observing the&#xD;
      practice and how it delivers care and interviewing a varied group of practice members,&#xD;
      including those that participated in implementing the intervention. These visits will happen&#xD;
      before and after the intervention. In addition, during the implementation of INTEGRATE-D, the&#xD;
      study team will conduct monthly telephone calls with a key informant at the intervention&#xD;
      practices. Measures: The study team will measure practice capacity for quality improvement&#xD;
      using the Change Process Capability Questionnaire (survey). The study team will measure&#xD;
      changes in care processes, as follows: for depression - screening for depression using the&#xD;
      Patient Health Questionnaire (PHQ)-9, rates of referral to behavioral health when patients&#xD;
      screen positive on the PHQ-9; for diabetes - the study team will use a composite measure of&#xD;
      DMII process of clinical care (e.g., screening for HbA1c, eye, and foot exams) and assess&#xD;
      discussion of and engagement in self-management activities (e.g., healthy eating, physical&#xD;
      activity). The study team will measure outcome change as a change in PHQ-9 and HbA1c. All&#xD;
      process and outcome measures will all be collected via chart audit. The study team will&#xD;
      measure feasibility and acceptability, perceived and actual, of INTEGRATE-D using&#xD;
      observation, semi-structured interviews, survey, and facilitator tracking data. Surveys will&#xD;
      use validated acceptability and feasibility measures. Statistical power: As this is a pilot&#xD;
      study, it is not meant to have the sample size needed to test for statistical significance.&#xD;
      Rather, this pilot is designed to show the promise of the INTEGRATE-D intervention and&#xD;
      provide the data need to do accurate power calculations for the larger, subsequent pragmatic&#xD;
      trial. Data Analysis. Qualitative analysis will follow a rigorous process whereby a team of&#xD;
      experienced qualitative researchers will identify emerging patterns or findings, and then&#xD;
      analyze data again to solidify these patterns into a coherent set of findings. Quantitative&#xD;
      analyses will use standard descriptive statistical methods and the study team will utilize&#xD;
      Generalized Linear Mixed Models to compare the effect of INTEGRATE-D intervention on process&#xD;
      outcome measures in the context of a cluster-randomized design.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of intervention</measure>
    <time_frame>At 15 months, post-intervention</time_frame>
    <description>A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appropriateness of the intervention</measure>
    <time_frame>At 15 months, post-intervention</time_frame>
    <description>A post-intervention four-item survey that evaluates the extent to which the intervention is fitting, suitable, applicable, and seems like a good match. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the intervention</measure>
    <time_frame>At 15 months, post-intervention</time_frame>
    <description>A post-intervention four-item survey that evaluates the extent to which the intervention is implementable, seems possible, seems doable, and seems easy to use. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>Change from baseline screening at 15 months</time_frame>
    <description>Measure of average blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>Change from baseline screening at 15 months</time_frame>
    <description>The nine-item validated screener measures depression severity. Questionnaire items are on a Likert scale and range from 0 (i.e., not at all) to +3 (i.e., nearly every day), and the total score ranges from 0 (i.e., minimal to none) to 27 (i.e., severe).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Type II Diabetes</condition>
  <condition>Primary Health Care</condition>
  <condition>Behavioral Health</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>INTEGRATE-D is a step-by-step blueprint that will assist practices with employing American Diabetes Association recommendations for integrating medical and psychosocial care. INTEGRATE-D consists of a set of implementation strategies that enable clinical teams to put evidence-based care in place. The intervention consists of training and education; audit and feedback materials; a facilitation implementation protocol; and health information technology support materials.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>INTEGRATE-D</intervention_name>
    <description>INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources including training on ADA-recommended care; and (4) Facilitation-to help implement the above strategies and the practice changes needed to align care with ADA recommendations.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        In order for patients to become eligible, their primary care practice must meet the&#xD;
        following inclusion criteria:&#xD;
&#xD;
          -  Primary care practices are affiliated with the Oregon Rural Practice-Based Network&#xD;
             (ORPRN), at time of recruitment.&#xD;
&#xD;
          -  Primary care practices must be located in Oregon.&#xD;
&#xD;
          -  Primary care practices have more than 100 adult patients aged 18 years or older with&#xD;
             an electronic health record-based diagnosis of Type II Diabetes Melitus (DMII).&#xD;
&#xD;
        Once the criteria for a primary care practice is satisfied, the inclusion criteria for DMII&#xD;
        patients includes the following:&#xD;
&#xD;
          -  Patients are 18 years of age or older.&#xD;
&#xD;
          -  Patients have an electronic health record-based diagnosis of DMII.&#xD;
&#xD;
          -  Patients were seen by an ORPRN practice at least once in the 15 months prior to the&#xD;
             start of intervention and once during the intervention.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Primary care practices that do not meet the inclusion criteria established are not eligible&#xD;
        for the pilot study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 16, 2021</last_update_submitted>
  <last_update_submitted_qc>June 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Deborah Cohen</investigator_full_name>
    <investigator_title>Vice Chair for Research</investigator_title>
  </responsible_party>
  <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>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04461405
org study id: 20783
nct id: NCT04461405
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In 2016, the American Diabetes Association (ADA) published its first-ever recommendations for
      integrating medical and psychosocial care for patients with Type II Diabetes Mellitus (DMII)
      and common mental and behavioral health (MH/BH) problems. In the United States, 30 million
      people live with DMII, and the majority receive care in primary care settings. By
      implementing the ADA recommendations, primary care practices will help patients better manage
      their MH/BH needs, meet recommended goals for DMII management, and reduce the risk of adverse
      outcomes. Making these recommendations a routine part of practice is a major change, and it
      is critical to understand how best to implement the ADA recommendations and test its
      effectiveness in the real world. The pilot study builds on a series of prior studies to
      refine and pilot test a package of implementation strategies - called INTEGRATE-D - to
      support practices in implementing the ADA recommendations for integrated DMII care.
      INTEGRATE-D combines the following evidence-based implementation strategies: (1) electronic
      health record (EHR)-based support - to help align EHR use with ADA recommendations and enable
      screening for depression, anxiety, diabetes distress, cognitive impairment, and
      self-management, and support identifying and tracking progress on patient treatments and
      goals; (2) Audit and feedback - which involves assisting practices in accessing clinically
      relevant, actionable data reports to inform measurement and identification of care gaps in
      DMII and behavioral health care; (3) Skill-building resources - including training on
      ADA-recommended care; and (4) Facilitation - to help implement the above strategies and
      tailor the intervention so that practice work on the subset of areas where practices are
      ready to change to align care with ADA recommendations. The study aims are Aim 1: Refine the
      INTEGRATE-D intervention by incorporating the preferences of stakeholders. In partnership
      with patients, primary care key stakeholders and experts, compile and refine the package of
      implementation strategies in the INTEGRATE-D intervention. Aim 2: Demonstrate feasibility,
      acceptability, and estimate cost. Conduct a mixed-method, pre-post pilot comparing two
      practices that receive the INTEGRATE-D intervention to two control practices that receive
      training materials only.
The INTEGRATE-D intervention is designed to support primary care practices with implementing
      ADA recommendations for integrating medical and psychosocial care for patients with DMII.
      Primary care practices will be the recipients of this support. For practices, the
      intervention will be 15 months long. The first three months will be a "Readiness Phase" where
      the study team assesses practices' capacity at baseline and a facilitator works with
      intervention practices to address capacity issues (e.g., help the practice produce a quality
      report) that can be barriers during active implementation. Then, intervention practices
      receive 12 months of "Active Intervention" with the same facilitator to align care processes
      with ADA recommendations. Pilot study design: The study team will use a randomized,
      mixed-method, pre-post design for this pilot study. The goal of this randomized pilot design
      is to evaluate the feasibility of recruitment, randomization, retention, assessment
      procedures, implementation of the INTEGRATE-D intervention, and provide insights into the
      effect of this pilot intervention on practice-level outcomes. Practice Sample and eligibility
      criteria: The sample for this pilot is four primary care practices. Practices with more than
      100 adult patients (≥18 years) with a diagnosis of DM (Type II; not gestational) are
      eligible. Practice Recruitment: Practices will be recruited from the ORPRN practice-based
      research network. ORPRN works with 279 primary care practices in the state of Oregon,
      including 51% that are rural and 42% clinician-owned practices. ORPRN recruiters will
      identify 50 potential practices and conduct a faxback to assess interest, capacity, and
      eligibility. Of interested practices, ORPRN and the study team will select 4 practices (2
      rural and 2 non-rural) that vary on whether practices employ a behavioral health clinician.
      The study team will purposefully vary practices on these characteristics based on previous
      work that demonstrated they influenced intervention uptake. Patient Sample: The study team
      will have three different patient samples. For chart audits, there will be two samples. (1)
      Patients with a diagnosis of DMII who have been seen at least once at the practice in the 15
      months prior to the intervention start date and at least once after the intervention start
      date will be included in the chart audit. The study team will randomly select 50 patients
      meeting these criteria. (2) Patients meeting the above criteria and screening positive for
      depression (i.e., those patients who have minimally exposed to the INTEGRATE-D intervention
      will also be randomly selected for chart audit. The study team will audit charts until there
      is a sample of 30 patients meeting these criteria. (3) From this latter group, the study team
      will select 5 patients at each of the two intervention practices to participate in an
      interview. Randomization Procedure: Practices will be randomized in a 1:1 ratio through a
      covariate-constrained randomization procedure. This is accomplished as follows. Prior to
      randomization, the study team will collect baseline data on practice-level factors (e.g.,
      practice size, ownership, rurality, patient panel demographics, etc.) that could influence
      process and outcome measures. These data will be collected as part of the recruitment
      process. The study team will construct all possible combinations of eligible practices into
      two groups. For each selected possible randomization, the study team will compare the balance
      between study arms in the important baseline data described above through a balance
      criterion. The study team will randomly select one randomization combination (from the 2
      combinations with the best balance) which will yield 2 practices in each study arm with good
      balance in important covariates. Data Collection: For this pilot study, the study team will
      collect mixed methods (survey, observation, interview, and chart audit) data. For control
      practices, data collection will include the collection of survey and chart audit data. These
      data will be collected at the same time as data collected from intervention practices.
      Intervention practices, in addition to completing surveys and participating in the chart
      audit, will participate in practice site visits, which include the study team observing the
      practice and how it delivers care and interviewing a varied group of practice members,
      including those that participated in implementing the intervention. These visits will happen
      before and after the intervention. In addition, during the implementation of INTEGRATE-D, the
      study team will conduct monthly telephone calls with a key informant at the intervention
      practices. Measures: The study team will measure practice capacity for quality improvement
      using the Change Process Capability Questionnaire (survey). The study team will measure
      changes in care processes, as follows: for depression - screening for depression using the
      Patient Health Questionnaire (PHQ)-9, rates of referral to behavioral health when patients
      screen positive on the PHQ-9; for diabetes - the study team will use a composite measure of
      DMII process of clinical care (e.g., screening for HbA1c, eye, and foot exams) and assess
      discussion of and engagement in self-management activities (e.g., healthy eating, physical
      activity). The study team will measure outcome change as a change in PHQ-9 and HbA1c. All
      process and outcome measures will all be collected via chart audit. The study team will
      measure feasibility and acceptability, perceived and actual, of INTEGRATE-D using
      observation, semi-structured interviews, survey, and facilitator tracking data. Surveys will
      use validated acceptability and feasibility measures. Statistical power: As this is a pilot
      study, it is not meant to have the sample size needed to test for statistical significance.
      Rather, this pilot is designed to show the promise of the INTEGRATE-D intervention and
      provide the data need to do accurate power calculations for the larger, subsequent pragmatic
      trial. Data Analysis. Qualitative analysis will follow a rigorous process whereby a team of
      experienced qualitative researchers will identify emerging patterns or findings, and then
      analyze data again to solidify these patterns into a coherent set of findings. Quantitative
      analyses will use standard descriptive statistical methods and the study team will utilize
      Generalized Linear Mixed Models to compare the effect of INTEGRATE-D intervention on process
      outcome measures in the context of a cluster-randomized design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptability of intervention
time frame: At 15 months, post-intervention
description: A post-intervention four-item survey that evaluates the extent to which the intervention meets practice members' approval, is appealing and is liked and welcomed. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.
measure: Appropriateness of the intervention
time frame: At 15 months, post-intervention
description: A post-intervention four-item survey that evaluates the extent to which the intervention is fitting, suitable, applicable, and seems like a good match. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.
measure: Feasibility of the intervention
time frame: At 15 months, post-intervention
description: A post-intervention four-item survey that evaluates the extent to which the intervention is implementable, seems possible, seems doable, and seems easy to use. The items will be assessed on a Likert scale, ranging from 1 to 5 (i.e., completely disagree to completely agree). Composite scores will be created.
measure: Hemoglobin A1c
time frame: Change from baseline screening at 15 months
description: Measure of average blood sugar
measure: Patient Health Questionnaire-9
time frame: Change from baseline screening at 15 months
description: The nine-item validated screener measures depression severity. Questionnaire items are on a Likert scale and range from 0 (i.e., not at all) to +3 (i.e., nearly every day), and the total score ranges from 0 (i.e., minimal to none) to 27 (i.e., severe).
arm group label: Intervention Arm
arm group type: Experimental
description: INTEGRATE-D is a step-by-step blueprint that will assist practices with employing American Diabetes Association recommendations for integrating medical and psychosocial care. INTEGRATE-D consists of a set of implementation strategies that enable clinical teams to put evidence-based care in place. The intervention consists of training and education; audit and feedback materials; a facilitation implementation protocol; and health information technology support materials.
arm group label: Control Arm
arm group type: No Intervention
description: Usual care
intervention type: Behavioral
intervention name: INTEGRATE-D
description: INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources including training on ADA-recommended care; and (4) Facilitation-to help implement the above strategies and the practice changes needed to align care with ADA recommendations.
arm group label: Intervention Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Deborah Cohen
investigator title: Vice Chair for Research
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No