<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/NCT02988193</url>
  </required_header>
  <id_info>
    <org_study_id>15-16045</org_study_id>
    <nct_id>NCT02988193</nct_id>
  </id_info>
  <brief_title>Piloting Healthcare Coordination in Hypertension</brief_title>
  <acronym>PRECISION</acronym>
  <official_title>Piloting Healthcare Coordination in Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Optima Integrated Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Optima Integrated Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The PRECISION study investigates the possibility of integrating a clinical decision support&#xD;
      analytic intelligence into the clinical care flow at University of California San Francisco&#xD;
      Medical Center (UCSF MC). optima-for-blood pressure [optima4BP], our innovation, transforms&#xD;
      the episodic and reactive nature of uncontrolled HTN pharmacological treatment management&#xD;
      into a process that is continuous, proactive, and personalized.&#xD;
&#xD;
      In addition, the clinical adoption of this &quot;technology of the future&quot; will be investigated to&#xD;
      establish its feasibility in being embedded into the clinical care flow.&#xD;
&#xD;
      Today's hypertension (HTN) management paradigm often fails to align current patient health&#xD;
      status with the most effective medication treatment. Without surveillance and rapid-cycles&#xD;
      analysis of current patient health status and treatment efficacy, HTN management remains a&#xD;
      struggle. optima4BP addresses pharmacological intervention management by identifying the need&#xD;
      for a drug treatment change and recommending the most appropriate drug optimization.&#xD;
&#xD;
      The PRECISION study represent a pilot trial intended to address 2 critical design components&#xD;
      of optima4BP:&#xD;
&#xD;
        1. Can optima4BP interoperate with multiple IT platforms to collect and distribute data?&#xD;
&#xD;
        2. What is the treating physician confidence in using optima4BP?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Goal: Conduct a prospective randomized pilot clinical trial embedded within the care delivery&#xD;
      system at UCSF Medical Center (UCSF). It is intended to evaluate the efficacy of optima4BP in&#xD;
      improving care coordination for patients with uncontrolled hypertension (HTN). Although&#xD;
      optima4BP has been evaluated during patient-physician office visits, it has not been&#xD;
      evaluated for its efficacy to support treatment changes remotely, over time. PRECISION&#xD;
      investigates this aspect and its impact on stakeholders (physicians and patients). The&#xD;
      outcomes will set the stage for a scaled-up study of 300 patients at UCSF.&#xD;
&#xD;
      Study Design: The patients will be randomized to 2 arms (a) optima4BP surveillance and&#xD;
      treatment recommendation support (O4BP); (b) usual care (UC) - usual care seen appropriate by&#xD;
      the treating physician). NOTE: The original design prior to study initiation considered a 3&#xD;
      arms randomization which would also include: enhanced care (EC) representing a &quot;step up&quot; from&#xD;
      UC by providing the physician with raw remotely collected BP values sent on a monthly cycle.&#xD;
      However, this arm was abandoned at enrollment because patients in the UC arm were proactively&#xD;
      reaching out to their physicians with remotely collected BP values from the Qardio® device&#xD;
      therefore rendering the initially projected Extended Care arm unuseful.&#xD;
&#xD;
      Every 30 days, the collection of patient information will be followed by an arm-specific&#xD;
      action. For identified patients in need of a medication change, O4BP physicians will receive&#xD;
      a treatment change recommendation for review. UC physicians will not receive any information.&#xD;
      All patients will undergo at least 2 in-office visits, a baseline visit and an exit visit.&#xD;
      All patients will be asked to provide every 30 days the following information: (a) adherence&#xD;
      to current HTN treatment; and (b) experienced side-effects and severity. The communication&#xD;
      will be performed via e-mail between Health-e-Heart (HeH) automated system&#xD;
      (https://www.health-eheartstudy.org/) and the patient. HeH will automatically obtain BP&#xD;
      values from the remote monitors provided to each patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2015</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>
    <intervention_model_description>The medication treatment intervention between arms differs in that the optima4BP arm uses an analytic intelligence algorithm to optimize drug treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Adoption of a Decision Support Artificial Intelligence</measure>
    <time_frame>6 months</time_frame>
    <description>Total number of participants that undergone a treatment change.&#xD;
This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>optima4BP Medication Management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:&#xD;
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;&#xD;
medication treatment recommendation;&#xD;
active link to access additional treatment analysis tools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Medication Management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>optima4BP Medication Management</intervention_name>
    <description>A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.</description>
    <arm_group_label>optima4BP Medication Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UCSF General Medicine patient&#xD;
&#xD;
          -  2 or more values on consecutive office visits within 12 months: systolic blood&#xD;
             pressure (SBP) &gt; 140 mmHg or diastolic blood pressure (DBP) &gt; 90&#xD;
&#xD;
          -  Therapy with at least 2 anti-hypertensive pharmacological classes at the time of the&#xD;
             last office visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not own a smartphone&#xD;
&#xD;
          -  Does not speak or read English&#xD;
&#xD;
          -  Planning to leave UCSF in the next year&#xD;
&#xD;
          -  Has a treating physician who refuses to enroll patients&#xD;
&#xD;
          -  Treating physician states that:&#xD;
&#xD;
        Patient cannot manage Qardio® arm blood pressure (BP) device (due to cognitive,&#xD;
        psychological, physical or other problems), or Patient is already at goal, or Should not&#xD;
        participate in the study for any other reason&#xD;
&#xD;
          -  Non-compliance with medical follow-up (frequent &quot;no shows&quot;)&#xD;
&#xD;
          -  Planned coronary revascularization in the next 6 months&#xD;
&#xD;
          -  Myocardial infarction, stroke, coronary revascularization, cardiac or aortic surgery&#xD;
             in the last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriela Voskerician, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Optima Integrated Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liviu Klein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Carlos</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <results_first_submitted>April 3, 2018</results_first_submitted>
  <results_first_submitted_qc>September 16, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 18, 2019</results_first_posted>
  <last_update_submitted>September 16, 2019</last_update_submitted>
  <last_update_submitted_qc>September 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>clinical reasoning artificial intelligence</keyword>
  <keyword>poorly controlled hypertension</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>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>optima4BP Medication Optimization</title>
          <description>optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:&#xD;
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;&#xD;
medication treatment recommendation;&#xD;
active link to access additional analysis tools.&#xD;
optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care Management</title>
          <description>Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>optima4BP Medication Management</title>
          <description>optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:&#xD;
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;&#xD;
medication treatment recommendation;&#xD;
active link to access additional analysis tools.&#xD;
optima4BP Medication Management: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care Medication Management</title>
          <description>Usual Care Medication Management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="28"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" spread="3"/>
                    <measurement group_id="B2" value="69" spread="5"/>
                    <measurement group_id="B3" value="70" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinical Adoption of a Decision Support Artificial Intelligence</title>
        <description>Total number of participants that undergone a treatment change.&#xD;
This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.</description>
        <time_frame>6 months</time_frame>
        <population>Clinical adoption based on physician acceptance of the treatment recommendation</population>
        <group_list>
          <group group_id="O1">
            <title>optima4BP Treatment Management</title>
            <description>optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:&#xD;
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;&#xD;
medication treatment recommendation;&#xD;
active link to access additional analysis tools.&#xD;
optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care Treatment Management</title>
            <description>Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Adoption of a Decision Support Artificial Intelligence</title>
          <description>Total number of participants that undergone a treatment change.&#xD;
This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.</description>
          <population>Clinical adoption based on physician acceptance of the treatment recommendation</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the entire course of the 6 months study.</time_frame>
      <desc>The definition of adverse event does not differ from clinicaltrials.gov Definition.</desc>
      <group_list>
        <group group_id="E1">
          <title>optima4BP Treatment Management</title>
          <description>optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:&#xD;
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;&#xD;
medication treatment recommendation;&#xD;
active link to access additional analysis tools.&#xD;
optima4BP medication optimization: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care Treatment Management</title>
          <description>Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gabriela Voskerician</name_or_title>
      <organization>Optima Integrated Health</organization>
      <phone>6502233588</phone>
      <email>gxv4@case.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02988193
org study id: 15-16045
nct id: NCT02988193
lead sponsor: 
collaborator: 
has dmc: Yes
The PRECISION study investigates the possibility of integrating a clinical decision support
      analytic intelligence into the clinical care flow at University of California San Francisco
      Medical Center (UCSF MC). optima-for-blood pressure [optima4BP], our innovation, transforms
      the episodic and reactive nature of uncontrolled HTN pharmacological treatment management
      into a process that is continuous, proactive, and personalized.

      In addition, the clinical adoption of this "technology of the future" will be investigated to
      establish its feasibility in being embedded into the clinical care flow.

      Today's hypertension (HTN) management paradigm often fails to align current patient health
      status with the most effective medication treatment. Without surveillance and rapid-cycles
      analysis of current patient health status and treatment efficacy, HTN management remains a
      struggle. optima4BP addresses pharmacological intervention management by identifying the need
      for a drug treatment change and recommending the most appropriate drug optimization.

      The PRECISION study represent a pilot trial intended to address 2 critical design components
      of optima4BP:

        1. Can optima4BP interoperate with multiple IT platforms to collect and distribute data?

        2. What is the treating physician confidence in using optima4BP?
Goal: Conduct a prospective randomized pilot clinical trial embedded within the care delivery
      system at UCSF Medical Center (UCSF). It is intended to evaluate the efficacy of optima4BP in
      improving care coordination for patients with uncontrolled hypertension (HTN). Although
      optima4BP has been evaluated during patient-physician office visits, it has not been
      evaluated for its efficacy to support treatment changes remotely, over time. PRECISION
      investigates this aspect and its impact on stakeholders (physicians and patients). The
      outcomes will set the stage for a scaled-up study of 300 patients at UCSF.

      Study Design: The patients will be randomized to 2 arms (a) optima4BP surveillance and
      treatment recommendation support (O4BP); (b) usual care (UC) - usual care seen appropriate by
      the treating physician). NOTE: The original design prior to study initiation considered a 3
      arms randomization which would also include: enhanced care (EC) representing a "step up" from
      UC by providing the physician with raw remotely collected BP values sent on a monthly cycle.
      However, this arm was abandoned at enrollment because patients in the UC arm were proactively
      reaching out to their physicians with remotely collected BP values from the Qardio® device
      therefore rendering the initially projected Extended Care arm unuseful.

      Every 30 days, the collection of patient information will be followed by an arm-specific
      action. For identified patients in need of a medication change, O4BP physicians will receive
      a treatment change recommendation for review. UC physicians will not receive any information.
      All patients will undergo at least 2 in-office visits, a baseline visit and an exit visit.
      All patients will be asked to provide every 30 days the following information: (a) adherence
      to current HTN treatment; and (b) experienced side-effects and severity. The communication
      will be performed via e-mail between Health-e-Heart (HeH) automated system
      (https://www.health-eheartstudy.org/) and the patient. HeH will automatically obtain BP
      values from the remote monitors provided to each patient.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The medication treatment intervention between arms differs in that the optima4BP arm uses an analytic intelligence algorithm to optimize drug treatment.
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical Adoption of a Decision Support Artificial Intelligence
time frame: 6 months
description: Total number of participants that undergone a treatment change.
This measure allows to evaluate the adoption of the optima4BP treatment recommendation based on the total number of patients that benefited from a treatment recommendation that was implemented by the treating physician.
arm group label: optima4BP Medication Management
arm group type: Experimental
description: optima4BP will provide a monthly medication optimization to the treating physician for review and subsequent implementation. The Treatment Recommendation will consist of:
curated blood pressure (BP) and heart rate (HR) values reported by the patient through the use of home monitoring BP arm cuff;
medication treatment recommendation;
active link to access additional treatment analysis tools.
arm group label: Usual Care Medication Management
arm group type: No Intervention
description: Usual care management will follow medication treatment management according to the physician preference. The treating physician will not be provided with a medication optimization recommendation, nor with monthly curated BP and HR values.
intervention type: Device
intervention name: optima4BP Medication Management
description: A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
arm group label: optima4BP Medication Management
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
last name: Gabriela Voskerician, PhD
role: Principal Investigator
affiliation: Optima Integrated Health
last name: Liviu Klein, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 