<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/NCT02996565</url>
  </required_header>
  <id_info>
    <org_study_id>HealthPartners Institute</org_study_id>
    <nct_id>NCT02996565</nct_id>
  </id_info>
  <brief_title>Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure</brief_title>
  <official_title>Pragmatic Trial Comparing Telehealth Care and Optimized Clinic-Based Care for Uncontrolled High Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pragmatic trial will compare two team-based care models for managing hypertension, Best&#xD;
      Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care&#xD;
      system in Minnesota. Clinics in the study are randomized to offer one of the two treatment&#xD;
      models to participants with uncontrolled hypertension.&#xD;
&#xD;
      The investigators aim to determine a) whether one model is more effective than the other for&#xD;
      lowering patient's blood pressure and b) which model patients prefer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of the study are:&#xD;
&#xD;
      Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and&#xD;
      other outcomes important to patients: best-practice clinic-based care and home-based&#xD;
      telehealth care.&#xD;
&#xD;
        -  Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care,&#xD;
           patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in&#xD;
           systolic blood pressure over 12 months of follow-up.&#xD;
&#xD;
        -  Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care,&#xD;
           patients in clinics assigned to telehealth care will report: a) fewer treatment side&#xD;
           effects; b) better ratings of patient experience of hypertension care; and c) higher&#xD;
           self-monitoring rates and confidence in self-care.&#xD;
&#xD;
      Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the&#xD;
      telehealth care and clinic-based care interventions using a mixed-methods approach supported&#xD;
      by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 17, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Trajectory over 12 months</time_frame>
    <description>Change in systolic BP, collected from medical records</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported side-effects of antihypertensive medications</measure>
    <time_frame>Change between baseline and 6 months</time_frame>
    <description>Questionnaire measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported patient experience/satisfaction with care</measure>
    <time_frame>Change between baseline and 6 months</time_frame>
    <description>Questionnaire measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported confidence in self-management of blood pressure</measure>
    <time_frame>Change between baseline and 6 months</time_frame>
    <description>Questionnaire measure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Trajectory, 6,12 and 24 months</time_frame>
    <description>change in diastolic BP, collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>Lipid Levels</measure>
    <time_frame>Trajectory, 12 and 24 months</time_frame>
    <description>element of cardiovascular risk models, collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>Statin Use (yes/no)</measure>
    <time_frame>Baseline and 24 months</time_frame>
    <description>element of cardiovascular risk models, collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>Smoking status (yes/no)</measure>
    <time_frame>Baseline, 6, 12, and 24 months</time_frame>
    <description>element of cardiovascular risk models, collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>10 year cardiovascular event risk (for patients ages 40-85)</measure>
    <time_frame>Trajectory over 12 and 24 months</time_frame>
    <description>Predictive risk model using individual elements of cardiovascular risk collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>30 year cardiovascular event risk (for patients ages 18-39)</measure>
    <time_frame>Trajectory over 12 and 24 months</time_frame>
    <description>Predictive risk model using individual elements of cardiovascular risk collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>Lab abnormalities related to hypertension and anti-hypertensive drug treatment</measure>
    <time_frame>Trajectory over 12 and 24 months</time_frame>
    <description>Collected from medical records</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypotension or fainting diagnosis codes</measure>
    <time_frame>Any occurrence between baseline and 24 months</time_frame>
    <description>Diagnosis codes collected from medical records</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3072</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Best Practice Clinic-Based Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telehealth Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Best Practice Clinic-Based Care</intervention_name>
    <description>Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote:&#xD;
Improved recognition of uncontrolled BP at primary care encounters,&#xD;
Therapeutic action to address uncontrolled BP at primary care encounters,&#xD;
Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.</description>
    <arm_group_label>Best Practice Clinic-Based Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telehealth Care</intervention_name>
    <description>All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically:&#xD;
Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device&#xD;
Systematic home BP telemonitoring with data transmitted into patient medical record&#xD;
Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email</description>
    <arm_group_label>Telehealth Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hypertension diagnosis code in medical record, twice in last 24 months&#xD;
&#xD;
          -  Attends study clinic for primary care visit within study period with uncontrolled&#xD;
             blood pressure&#xD;
&#xD;
          -  Systolic blood pressure &gt;=150 mm Hg or Diastolic blood pressure &gt;=95 mm Hg at current&#xD;
             visit&#xD;
&#xD;
          -  Systolic blood pressure &gt;=150 mm Hg or Diastolic blood pressure &gt;=95 mm Hg at most&#xD;
             recent previous visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  End Stage Kidney Disease&#xD;
&#xD;
          -  Patients in hospice care and patients who permanently reside in a nursing home&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Margolis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HealthPartners Institution</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HealthPartners Institute</name>
      <address>
        <city>Bloomington</city>
        <state>Minnesota</state>
        <zip>55425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 12, 2021</last_update_submitted>
  <last_update_submitted_qc>July 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clinic care</keyword>
  <keyword>Team-based care</keyword>
  <keyword>Medication Therapy Management (MTM)</keyword>
  <keyword>Telehealth</keyword>
  <keyword>Cluster-randomized</keyword>
  <keyword>Home blood pressure monitoring</keyword>
  <keyword>Pharmacist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 25, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT02996565/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>November 22, 2022</submitted>
  </pending_results>
  <!-- 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/NCT02996565
org study id: HealthPartners Institute
nct id: NCT02996565
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pragmatic trial will compare two team-based care models for managing hypertension, Best
      Practice Clinic-based Care and Telehealth Care with pharmacist management, in a large care
      system in Minnesota. Clinics in the study are randomized to offer one of the two treatment
      models to participants with uncontrolled hypertension.

      The investigators aim to determine a) whether one model is more effective than the other for
      lowering patient's blood pressure and b) which model patients prefer.
The objectives of the study are:

      Aim 1: Compare the effects of two evidence-based strategies on lowering blood pressure and
      other outcomes important to patients: best-practice clinic-based care and home-based
      telehealth care.

        -  Hypothesis 1.1: Compared with patients in clinics assigned to clinic-based care,
           patients in clinics assigned to telehealth care will have a 5 mm Hg greater change in
           systolic blood pressure over 12 months of follow-up.

        -  Hypothesis 1.2: Compared with patients in clinics assigned to clinic-based care,
           patients in clinics assigned to telehealth care will report: a) fewer treatment side
           effects; b) better ratings of patient experience of hypertension care; and c) higher
           self-monitoring rates and confidence in self-care.

      Aim 2: Conduct an evaluation of the reach, adoption, implementation, and maintenance of the
      telehealth care and clinic-based care interventions using a mixed-methods approach supported
      by the RE-AIM framework and the Consolidated Framework for Implementation Research (CFIR).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Systolic Blood Pressure
time frame: Trajectory over 12 months
description: Change in systolic BP, collected from medical records
measure: Self-reported side-effects of antihypertensive medications
time frame: Change between baseline and 6 months
description: Questionnaire measure
measure: Self-reported patient experience/satisfaction with care
time frame: Change between baseline and 6 months
description: Questionnaire measure
measure: Self-reported confidence in self-management of blood pressure
time frame: Change between baseline and 6 months
description: Questionnaire measure
measure: Diastolic Blood Pressure
time frame: Trajectory, 6,12 and 24 months
description: change in diastolic BP, collected from medical records
measure: Lipid Levels
time frame: Trajectory, 12 and 24 months
description: element of cardiovascular risk models, collected from medical records
measure: Statin Use (yes/no)
time frame: Baseline and 24 months
description: element of cardiovascular risk models, collected from medical records
measure: Smoking status (yes/no)
time frame: Baseline, 6, 12, and 24 months
description: element of cardiovascular risk models, collected from medical records
measure: 10 year cardiovascular event risk (for patients ages 40-85)
time frame: Trajectory over 12 and 24 months
description: Predictive risk model using individual elements of cardiovascular risk collected from medical records
measure: 30 year cardiovascular event risk (for patients ages 18-39)
time frame: Trajectory over 12 and 24 months
description: Predictive risk model using individual elements of cardiovascular risk collected from medical records
measure: Lab abnormalities related to hypertension and anti-hypertensive drug treatment
time frame: Trajectory over 12 and 24 months
description: Collected from medical records
measure: Hypotension or fainting diagnosis codes
time frame: Any occurrence between baseline and 24 months
description: Diagnosis codes collected from medical records
arm group label: Best Practice Clinic-Based Care
arm group type: Active Comparator
description: Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Best Practice Clinic-Based Care intervention.
arm group label: Telehealth Care
arm group type: Active Comparator
description: Patients with uncontrolled hypertension who receive primary care in clinics assigned to the Telehealth Care intervention.
intervention type: Other
intervention name: Best Practice Clinic-Based Care
description: Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote:
Improved recognition of uncontrolled BP at primary care encounters,
Therapeutic action to address uncontrolled BP at primary care encounters,
Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks.
arm group label: Best Practice Clinic-Based Care
intervention type: Other
intervention name: Telehealth Care
description: All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically:
Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device
Systematic home BP telemonitoring with data transmitted into patient medical record
Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email
arm group label: Telehealth Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Margolis, MD
role: Principal Investigator
affiliation: HealthPartners Institution
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: Yes
ipd description: We will provide a de-identified, individual-level dataset to PCORI if requested at the end of the study. The dataset will be made publicly available and will contain no identifying information.
provided document: 
submitted: November 22, 2022