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/NCT06002165</url>
    </required_header>
    <id_info>
      <org_study_id>23-0968</org_study_id>
      <secondary_id>OT2HL158287</secondary_id>
      <nct_id>NCT06002165</nct_id>
    </id_info>
    <brief_title>Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle</brief_title>
    <acronym>ACHIEVE</acronym>
    <official_title>Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle: ACHIEVE (Advancing Community and Clinical Care for Childbirth-related Hypertension Through Implementation, Engagement, and Valuing Equity)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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>
        The goal of this clinical trial is to test an approach to improve care for pregnant and&#xD;
        post-partum patients with high blood pressure. The study participants are providers and staff&#xD;
        in prenatal care clinics, and the condition of interest is severe hypertension. The research&#xD;
        questions are:&#xD;
  &#xD;
          1. Does the ACHIEVE intervention increase the quality and accuracy of measuring patient&#xD;
             blood pressure?&#xD;
  &#xD;
          2. Does the ACHIEVE intervention increase the documentation of delivery of patient&#xD;
             education on hypertension?&#xD;
  &#xD;
          3. Does the ACHIEVE intervention result in better recognition and treatment of severe&#xD;
             hypertension during practice sessions (simulations)?&#xD;
  &#xD;
          4. Does the ACHIEVE intervention result in better recognition and treatment of severe&#xD;
             hypertension for patients who come to the clinic?&#xD;
  &#xD;
        Participants from 20 clinics in North Carolina will work with an ACHIEVE Nurse Coordinator&#xD;
        who will deliver training, coaching, and simulations. Three groups of clinics will be phased&#xD;
        into Active Implementation every six months. The study team will examine data collected&#xD;
        before, during, and after the intervention to see if the results show improvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        New or worsening high blood pressure in pregnancy can develop into a disease called&#xD;
        preeclampsia. If left untreated, preeclampsia may turn into eclampsia. Eclampsia occurs when&#xD;
        a pregnant person has a seizure or a stroke, which can lead to lifelong health problems, or&#xD;
        even death. In 2018, 14% of pregnant people who gave birth in North Carolina experienced high&#xD;
        blood pressure. Rural, low-income, and women of color are at greatest risk for complications&#xD;
        of high blood pressure in pregnancy and postpartum. These same individuals also face&#xD;
        challenges in accessing care. To improve maternal health outcomes for these patients, the&#xD;
        Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During&#xD;
        Pregnancy and Postpartum Period Safety Bundle (HTN bundle) which includes five areas of&#xD;
        focus: (1) Readiness of clinics to change practices (2) Recognition of high blood pressure&#xD;
        (3) Response to patients with high blood pressure during pregnancy or postpartum; 4)&#xD;
        Reporting/Systems Learning to track data related to clinic changes and (5) Respectful Care to&#xD;
        ensure equity and respect in care of patients. Initially released in 2015, The HTN bundle has&#xD;
        been used by hospitals to improve recognition and treatment of high blood pressure in&#xD;
        birthing people. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related&#xD;
        Hypertension through Implementation, Engagement, and Valuing Equity) Initiative was developed&#xD;
        to support outpatient clinics in providing more effective care to pregnant individuals with&#xD;
        high blood pressure. Adapting this bundle for community clinics providing pregnancy care has&#xD;
        the potential to reach more birthing people outside the hospital setting who are most&#xD;
        vulnerable to complications.&#xD;
  &#xD;
        In the initial phase of ACHIEVE, the study team partnered with three rural Piedmont Health&#xD;
        Services (PHS) clinics that serve mostly White and Latinx patients. The inpatient HTN bundle&#xD;
        was adapted to fit their setting and re-named the Outpatient Hypertension (O-HTN) bundle.&#xD;
        Additionally, a coalition was established to engage patients, clinic providers/staff, and the&#xD;
        broader community to: (a) understand factors influencing maternal health including economic&#xD;
        stability, education, health care access, and community context, (b) assess what makes it&#xD;
        easier or harder to implement the O-HTN bundle in community outpatient clinic settings, (c)&#xD;
        adapt the O-HTN bundle to fit those settings and populations, and (d) select and tailor&#xD;
        changes to clinic practices using continuous cycles of learning, measuring and adapting to be&#xD;
        the most effective and sustainable for the organization. Building on this formative work, the&#xD;
        goal of the clinical trial is to determine the impact of three implementation strategies&#xD;
        (training, coaching, facilitation) in 20 outpatient clinics in central North Carolina. Usual&#xD;
        clinic care for severe hypertension will be compared to the care provided after a practice&#xD;
        has 12 months of implementation support from the ACHIEVE Nurse Coordinator. ACHIEVE partners&#xD;
        include healthcare leadership, clinic providers and staff, community-based organizations, and&#xD;
        individuals with lived experience who will work together on this project. If the project&#xD;
        succeeds in improving care, the ACHIEVE model will be shared across the state and nationally&#xD;
        to support healthier birthing people and communities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">April 2027</completion_date>
    <primary_completion_date type="Anticipated">April 2027</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>Parallel Assignment</intervention_model>
      <intervention_model_description>The study design for the clinical trial component of the ACHIEVE initiative is a hybrid type III, multiple baseline design. Study team members will recruit and collect data from 20 outpatient clinics that serve pregnant patients. The clinic staff and providers will receive the intervention (a set of tailored implementation strategies) to increase their capacity to deliver timely care to patients with severe hypertension. The 20 clinics will receive the intervention in three consecutive and overlapping cohorts. The first cohort, 8 outpatient prenatal care clinics in Orange and Alamance Counties, will receive the intervention in Months 7-18 of the study. The second cohort, 6 clinics in Durham County, will receive the intervention in Months 13-24, six months after Cohort 1 begins. The third cohort, 6 clinics in Wake County, will receive the intervention in Months 19-30, twelve months after Cohort 1 begins.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Normalized percentage of achieving the highest possible score for blood pressure measurement technique</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Derived from an 11-item observation checklist with a maximum score of 11 points per observation (sample: all Medical Support Personnel who are trained to measure blood pressure for prenatal patients). The construct is fidelity to blood pressure measurement technique; a higher score represents an improvement in fidelity; the range for the checklist is 0-11 which will be translated into a normalized percentage from 0-100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 2 points per chart (sample: 20 charts per clinic randomly selected from all pregnant patients who delivered up to 6-months prior to the data collection timepoint). The construct is fidelity to the patient education protocol; a higher score represents an improvement in fidelity; the range for the score is 0-2 which will be translated into a normalized percentage from 0-100.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension</measure>
      <time_frame>Up to 13 months</time_frame>
      <description>Derived from a 7-item checklist with a maximum score of 14 points per simulation (sample: all care teams in clinics that provide prenatal care.) The outcome measure will be assessed at the beginning, middle, and end of the Active Implementation phase. The construct is fidelity to recognition and response to simulated episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the checklist is 0-14 which will be translated into a normalized percentage from 0-100.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN</measure>
      <time_frame>Up to 36 months</time_frame>
      <description>Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 4 points per chart (sample: all episodes of severe HTN among patients who were pregnant or up to six weeks postpartum and received prenatal care from a participating clinic in the 12 months prior to the data collection timepoint). The outcome measure will be assessed in the 12 months before, during, and after the Active Implementation phase. The construct is recognition and response to actual episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the score is 0-4 which will be translated into a normalized percentage of 0-100.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4000</enrollment>
    <condition>Pregnancy Related</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Usual Care Arm</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All 20 clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Implementation Arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All 20 clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Usual Care</intervention_name>
      <description>All clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all 20 enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute &quot;usual care.&quot;</description>
      <arm_group_label>Usual Care Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ACHIEVE Multi-component Implementation Strategy</intervention_name>
      <description>The intervention is comprised of three implementation strategies: facilitation/coaching, training, and simulation. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these three strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner.</description>
      <arm_group_label>Active Implementation Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          INCLUSION CRITERIA&#xD;
  &#xD;
            1. Sites/Facilities Enrolling Participants&#xD;
  &#xD;
               The 20 prenatal care clinics being recruited must meet all of the following inclusion&#xD;
               criteria:&#xD;
  &#xD;
               a. Physical location of the clinic is in Orange, Alamance, Durham, or Wake County b.&#xD;
               The clinic patient population includes ≥ 50 births per year c. The clinic uses an&#xD;
               electronic health record system&#xD;
  &#xD;
               Additionally, the clinic's patient population must meet one or more of the following&#xD;
               inclusion criteria:&#xD;
  &#xD;
               a. ≥ 50% uninsured or insured by Medicaid b. ≥ 20% Black / African American c. ≥ 20%&#xD;
               rural residents&#xD;
  &#xD;
            2. Clinic Participants&#xD;
  &#xD;
               Participants will include volunteers within the following categories:&#xD;
  &#xD;
                 1. Implementation Team&#xD;
  &#xD;
                 2. Care Team&#xD;
  &#xD;
                 3. Medical Support Personnel&#xD;
  &#xD;
            3. Patients (Patient Education Cohort)&#xD;
  &#xD;
                 1. Gave birth up to six months prior to the data collection timepoint&#xD;
  &#xD;
                 2. Received at least two or more prenatal care visits from the participating clinic&#xD;
  &#xD;
                 3. At least one of the two prenatal care visits must occur between 20- and 34-weeks&#xD;
                    gestation&#xD;
  &#xD;
            4. Patients: (Timely Delivery of Care Cohort)&#xD;
  &#xD;
                 1. Pregnant or up to six weeks post-partum in the 12 months prior to the data&#xD;
                    collection timepoint.&#xD;
  &#xD;
                 2. Had at least one documented episode of severe hypertension (systolic blood&#xD;
                    pressure of 160 mmHg or higher, or diastolic blood pressure of 110 mmHg or&#xD;
                    higher) during a visit encounter with a participating clinic&#xD;
  &#xD;
                 3. Individual pregnant or postpartum people should have all episodes included if&#xD;
                    they present with severe range blood pressures more than once on different days&#xD;
  &#xD;
          EXCLUSION CRITERIA&#xD;
  &#xD;
            1. Sites/Facilities Enrolling Participants&#xD;
  &#xD;
               a. Clinics that were part of the Pilot Phase of this study b. Clinics that had&#xD;
               recently completed a similar quality improvement project focused on severe&#xD;
               hypertension&#xD;
  &#xD;
            2. Implementation Team&#xD;
  &#xD;
               a. Provider cannot be a Medical Resident&#xD;
  &#xD;
            3. Care Team&#xD;
  &#xD;
               a. Provider cannot be a Medical Resident&#xD;
  &#xD;
            4. Medical Support Personnel&#xD;
  &#xD;
               a. None&#xD;
  &#xD;
            5. Patients (Patient Education Cohort)&#xD;
  &#xD;
               a. None&#xD;
  &#xD;
            6. Patients (Timely Delivery of Care Cohort) a. None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mary K Menard, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of North Carolina, Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Catherine Rohweder, DrPH</last_name>
      <phone>919-843-9329</phone>
      <email>rohweder@email.unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lindsay Bailey, MPH</last_name>
      <phone>304-549-8076</phone>
      <email>lbailey3@email.unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27516</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Mary K Menard, MD, MPH</last_name>
        <phone>919-619-7824</phone>
        <email>kate_menard@med.unc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Catherine L Rohweder, DrPH</last_name>
        <phone>919-843-9329</phone>
        <email>rohweder@email.unc.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Mary K Menard, MD, MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jennifer Leeman, DrPH, MDiv</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Farahi Narges, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alexandra Lightfoot, EdD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Harper Kimberly, MSN, RN, MHA</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Teal Nicole, MD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jennifer Costello, MS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Catherine Rohweder, DrPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Johanna Quist-Nelson, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lin Feng-Chang, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 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 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hypertension</keyword>
    <keyword>Pregnancy Related</keyword>
    <keyword>Practice Guidelines</keyword>
    <keyword>Prenatal Care</keyword>
    <keyword>Quality Improvement</keyword>
    <keyword>Implementation Science</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>Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in UNC Chapel Hill's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).</ipd_time_frame>
      <ipd_access_criteria>Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.</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/NCT06002165
  org study id: 23-0968
  secondary id: OT2HL158287
  nct id: NCT06002165
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test an approach to improve care for pregnant and
        post-partum patients with high blood pressure. The study participants are providers and staff
        in prenatal care clinics, and the condition of interest is severe hypertension. The research
        questions are:
  
          1. Does the ACHIEVE intervention increase the quality and accuracy of measuring patient
             blood pressure?
  
          2. Does the ACHIEVE intervention increase the documentation of delivery of patient
             education on hypertension?
  
          3. Does the ACHIEVE intervention result in better recognition and treatment of severe
             hypertension during practice sessions (simulations)?
  
          4. Does the ACHIEVE intervention result in better recognition and treatment of severe
             hypertension for patients who come to the clinic?
  
        Participants from 20 clinics in North Carolina will work with an ACHIEVE Nurse Coordinator
        who will deliver training, coaching, and simulations. Three groups of clinics will be phased
        into Active Implementation every six months. The study team will examine data collected
        before, during, and after the intervention to see if the results show improvement.
  New or worsening high blood pressure in pregnancy can develop into a disease called
        preeclampsia. If left untreated, preeclampsia may turn into eclampsia. Eclampsia occurs when
        a pregnant person has a seizure or a stroke, which can lead to lifelong health problems, or
        even death. In 2018, 14% of pregnant people who gave birth in North Carolina experienced high
        blood pressure. Rural, low-income, and women of color are at greatest risk for complications
        of high blood pressure in pregnancy and postpartum. These same individuals also face
        challenges in accessing care. To improve maternal health outcomes for these patients, the
        Alliance for Innovation on Maternal Safety (AIM) developed the Severe Hypertension During
        Pregnancy and Postpartum Period Safety Bundle (HTN bundle) which includes five areas of
        focus: (1) Readiness of clinics to change practices (2) Recognition of high blood pressure
        (3) Response to patients with high blood pressure during pregnancy or postpartum; 4)
        Reporting/Systems Learning to track data related to clinic changes and (5) Respectful Care to
        ensure equity and respect in care of patients. Initially released in 2015, The HTN bundle has
        been used by hospitals to improve recognition and treatment of high blood pressure in
        birthing people. The ACHIEVE (Advancing Community and Clinical Care for Childbirth-related
        Hypertension through Implementation, Engagement, and Valuing Equity) Initiative was developed
        to support outpatient clinics in providing more effective care to pregnant individuals with
        high blood pressure. Adapting this bundle for community clinics providing pregnancy care has
        the potential to reach more birthing people outside the hospital setting who are most
        vulnerable to complications.
  
        In the initial phase of ACHIEVE, the study team partnered with three rural Piedmont Health
        Services (PHS) clinics that serve mostly White and Latinx patients. The inpatient HTN bundle
        was adapted to fit their setting and re-named the Outpatient Hypertension (O-HTN) bundle.
        Additionally, a coalition was established to engage patients, clinic providers/staff, and the
        broader community to: (a) understand factors influencing maternal health including economic
        stability, education, health care access, and community context, (b) assess what makes it
        easier or harder to implement the O-HTN bundle in community outpatient clinic settings, (c)
        adapt the O-HTN bundle to fit those settings and populations, and (d) select and tailor
        changes to clinic practices using continuous cycles of learning, measuring and adapting to be
        the most effective and sustainable for the organization. Building on this formative work, the
        goal of the clinical trial is to determine the impact of three implementation strategies
        (training, coaching, facilitation) in 20 outpatient clinics in central North Carolina. Usual
        clinic care for severe hypertension will be compared to the care provided after a practice
        has 12 months of implementation support from the ACHIEVE Nurse Coordinator. ACHIEVE partners
        include healthcare leadership, clinic providers and staff, community-based organizations, and
        individuals with lived experience who will work together on this project. If the project
        succeeds in improving care, the ACHIEVE model will be shared across the state and nationally
        to support healthier birthing people and communities.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The study design for the clinical trial component of the ACHIEVE initiative is a hybrid type III, multiple baseline design. Study team members will recruit and collect data from 20 outpatient clinics that serve pregnant patients. The clinic staff and providers will receive the intervention (a set of tailored implementation strategies) to increase their capacity to deliver timely care to patients with severe hypertension. The 20 clinics will receive the intervention in three consecutive and overlapping cohorts. The first cohort, 8 outpatient prenatal care clinics in Orange and Alamance Counties, will receive the intervention in Months 7-18 of the study. The second cohort, 6 clinics in Durham County, will receive the intervention in Months 13-24, six months after Cohort 1 begins. The third cohort, 6 clinics in Wake County, will receive the intervention in Months 19-30, twelve months after Cohort 1 begins.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Normalized percentage of achieving the highest possible score for blood pressure measurement technique
  time frame: Up to 48 months
  description: Derived from an 11-item observation checklist with a maximum score of 11 points per observation (sample: all Medical Support Personnel who are trained to measure blood pressure for prenatal patients). The construct is fidelity to blood pressure measurement technique; a higher score represents an improvement in fidelity; the range for the checklist is 0-11 which will be translated into a normalized percentage from 0-100.
  measure: Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.
  time frame: Up to 48 months
  description: Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 2 points per chart (sample: 20 charts per clinic randomly selected from all pregnant patients who delivered up to 6-months prior to the data collection timepoint). The construct is fidelity to the patient education protocol; a higher score represents an improvement in fidelity; the range for the score is 0-2 which will be translated into a normalized percentage from 0-100.
  measure: Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension
  time frame: Up to 13 months
  description: Derived from a 7-item checklist with a maximum score of 14 points per simulation (sample: all care teams in clinics that provide prenatal care.) The outcome measure will be assessed at the beginning, middle, and end of the Active Implementation phase. The construct is fidelity to recognition and response to simulated episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the checklist is 0-14 which will be translated into a normalized percentage from 0-100.
  measure: Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN
  time frame: Up to 36 months
  description: Derived from retrospective chart audits using a chart abstraction tool and scoring system with a maximum score of 4 points per chart (sample: all episodes of severe HTN among patients who were pregnant or up to six weeks postpartum and received prenatal care from a participating clinic in the 12 months prior to the data collection timepoint). The outcome measure will be assessed in the 12 months before, during, and after the Active Implementation phase. The construct is recognition and response to actual episodes of severe hypertension; a higher score represents an improvement in fidelity; the range for the score is 0-4 which will be translated into a normalized percentage of 0-100.
  arm group label: Usual Care Arm
  arm group type: Placebo Comparator
  description: The Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All 20 clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase.
  arm group label: Active Implementation Arm
  arm group type: Active Comparator
  description: The Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All 20 clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart).
  intervention type: Behavioral
  intervention name: Usual Care
  description: All clinics in North Carolina Perinatal Region IV have access to Severe HTN Bundle resources on the AIM website (https://saferbirth.org/psbs/severe-hypertension-in-pregnancy) and the locally adapted Outpatient HTN Bundle resources on the North Carolina Perinatal Region IV Provider Support Network website (https://www.mombaby.org/outpatient-bundle-for-severe-hypertension/). At baseline, the clinical leadership of all 20 enrolled sites will receive direct communication via email that describes and provides links to the available resources. This will constitute "usual care."
  arm group label: Usual Care Arm
  intervention type: Behavioral
  intervention name: ACHIEVE Multi-component Implementation Strategy
  description: The intervention is comprised of three implementation strategies: facilitation/coaching, training, and simulation. The ACHIEVE study team, primarily the Nurse Coordinator, will engage teams within each clinic to participate in quality improvement activities utilizing these three strategies. The Nurse Coordinator will train the providers/staff on the O-HTN bundle components, facilitate corresponding office systems and workflow changes, and conduct simulations of patients with severe hypertension so care teams can practice the steps involved in recognizing and responding to episodes of severe hypertension in a timely manner.
  arm group label: Active Implementation Arm
  criteria: 
  gender: All
  minimum age: 0 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Mary K Menard, MD, MPH
  role: Principal Investigator
  affiliation: University of North Carolina, Chapel Hill
  last name: Catherine Rohweder, DrPH
  phone: 919-843-9329
  email: rohweder@email.unc.edu
  last name: Lindsay Bailey, MPH
  phone: 304-549-8076
  email: lbailey3@email.unc.edu
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  country: United States
  responsible party type: Sponsor
  mesh term: Hypertension
  sharing ipd: Yes
  ipd description: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with The University of North Carolina at Chapel Hill.
  ipd info type: Study Protocol
  ipd time frame: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in UNC Chapel Hill's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be provided).
  ipd access criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina at Chapel Hill.