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/NCT06014268</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 319691</org_study_id>
      <nct_id>NCT06014268</nct_id>
    </id_info>
    <brief_title>Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke</brief_title>
    <acronym>eCDSS</acronym>
    <official_title>Implementation of an Electronic Clinical Decision Support System (eCDSS) for Prevention of Atrial Fibrillation-related Stroke in a Mental Healthcare Setting: a Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>South London and Maudsley NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>South London and Maudsley NHS Foundation Trust</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Cardiovascular diseases are the leading cause of premature mortality in people with serious&#xD;
        mental illness (such as schizophrenia, bipolar disorder, schizoaffective disorder) and&#xD;
        dementia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is associated&#xD;
        with fivefold increased risk of stroke also contributing to heart failure and death.&#xD;
  &#xD;
        Electronic clinical decision support systems (eCDSS) are computer based programs that analyse&#xD;
        data within electronic health records (EHRs) and provide prompts to assist health care&#xD;
        providers in implementing evidencebased clinical guidelines. Adoption of an eCDSS to address&#xD;
        the risk of stroke in people with AF and co-morbid mental illness presents a unique&#xD;
        opportunity for research but requires evidence of acceptability and feasibility.&#xD;
  &#xD;
        This study aims to establish the feasibility and acceptability of an eCDSS&#xD;
        (Cogstack@Maudsley) for AF-related stroke prevention in Mental Health of Older Adults&#xD;
        inpatient wards.&#xD;
  &#xD;
        First, we will conduct surveys and interviews with clinicians on inpatient wards to scope&#xD;
        experiences of managing atrial fibrillation in secondary mental healthcare settings and&#xD;
        attitudes towards use of digital technologies to aid in clinical decision making. A&#xD;
        feasibility study will then be run to evaluate the acceptability and feasibility of&#xD;
        implementing eCDSS on inpatient wards. Finally, participating clinicians will be invited to&#xD;
        take part in a survey and interview which will explore their experiences and attitudes&#xD;
        towards using the eCDSS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular diseases are the leading cause of premature mortality in people with serious&#xD;
        mental illness (SMI) (such as schizophrenia, bipolar disorder, and schizoaffective disorder)&#xD;
        and dementia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is&#xD;
        associated with fivefold increased risk of stroke also contributing to heart failure and&#xD;
        death.&#xD;
  &#xD;
        According to the National Institute for Health and Care Excellence (NICE) guidelines, the&#xD;
        management of AF requires a comprehensive assessment of risk factors for thromboembolic&#xD;
        (using the CHAD2AD2-VASc tool) and bleeding events (using ORBIT or HAS-BLED tools), and&#xD;
        long-term treatment with oral anticoagulants (OAC) when appropriate.&#xD;
  &#xD;
        Although oral anticoagulation has been effective in reducing the risk of stroke in people&#xD;
        with AF, underuse continues to be reported, especially in patients with co-morbid SMI and/or&#xD;
        dementia.&#xD;
  &#xD;
        The primary objective of this study is to establish the feasibility and acceptability of an&#xD;
        eCDSS compromising a real-time computerised alerting and clinical decision support system for&#xD;
        AF-related stroke prevention in secondary mental healthcare. We will conduct a process&#xD;
        evaluation to assess the barriers, facilitators, and unintended consequences of implementing&#xD;
        the system onto an inpatient mental health of older adult ward. Data gathered from this study&#xD;
        will allow us to refine the system, address potential problems with future successful&#xD;
        implementation, and inform larger trials.&#xD;
  &#xD;
        This feasibility study will be conducted over a period of 3 months in Mental Health of Older&#xD;
        Adults inpatient wards at South London and Maudsley NHS Foundation Trust.&#xD;
  &#xD;
        Wards participating in the study will receive the electronic clinical decision support system&#xD;
        (eCDSS) with clinicians being the end-users.&#xD;
  &#xD;
        The key digital tool to be used for eCDSS in this study is CogStack which is an open source&#xD;
        information retrieval and extraction system with the capability to offer near real-time&#xD;
        natural language processing (NLP) of electronic health records. The eCDSS will alert&#xD;
        clinicians if patients with documented atrial fibrillation are admitted to the hospital under&#xD;
        their care. Alerts will be triggered by the presence of old or new diagnosis of atrial&#xD;
        fibrillation (AF) on the electronic health records.&#xD;
  &#xD;
        The eCDSS will consist of prompts appearing on patients' electronic health records asking&#xD;
        clinicians to clinically assess the risk of stroke (using CHAD2AD2-VASc tool) and the risk of&#xD;
        bleeding (using the ORBIT tool) and record the scores in clinical notes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 21, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>feasibility and acceptability of the eCDSS</measure>
      <time_frame>before and 3 months post intervention</time_frame>
      <description>Acceptability - Extent to which eCDSS is perceived by clinician users to be appropriate and acceptable in prompting evidence-based atrial fibrillation management, and an effective system for improving atrial fibrillation care (measured by qualitative methods - pre- and post- survey and semi-structured interviews).&#xD;
  Feasibility - Ability to recruit wards and clinicians to the study (measured by retention and participation of clinicians on recruited wards through to end of study)</description>
    </primary_outcome>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Atrial Fibrillation</condition>
    <condition>Stroke</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>electronic clinical decision support system</intervention_name>
      <description>eCDSS will alert clinicians if patients with documented atrial fibrillation are admitted to the hospital under their care.&#xD;
  The eCDSS will consist of prompts appearing on patients' electronic health records asking clinicians to clinically assess the risk of stroke (using CHAD2AD2-VASc tool) and the risk of bleeding (using the ORBIT tool) and record the scores on ePJS. Recommendations include reviewing the stroke and bleeding scores in specific cases, referral to an anticoagulation clinic to reduce AF related stroke risk (a referral template and emails/ telephone of the OAC clinics will be provided) and managing modifiable bleeding risk factors.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          healthcare providers including junior Drs, consultants, and pharmacists on wards&#xD;
          participating in the study (AL1 Ward at Maudsley, Chelsham House at Bethlem, Hayworth Ward&#xD;
          at Ladywell)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Wards will be entered in the study if their respective ward manager agrees to&#xD;
               participate. Clinical staff on participating wards will be eligible to take part in&#xD;
               the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Staff on recruited wards who are not of a clinical or healthcare professional&#xD;
               background&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>South London and Maudsley Nhs Foundation Trust</name>
        <address>
          <city>London</city>
          <zip>BR3 3BX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>electronic clinical decision support system</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06014268
  org study id: IRAS 319691
  nct id: NCT06014268
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Cardiovascular diseases are the leading cause of premature mortality in people with serious
        mental illness (such as schizophrenia, bipolar disorder, schizoaffective disorder) and
        dementia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is associated
        with fivefold increased risk of stroke also contributing to heart failure and death.
  
        Electronic clinical decision support systems (eCDSS) are computer based programs that analyse
        data within electronic health records (EHRs) and provide prompts to assist health care
        providers in implementing evidencebased clinical guidelines. Adoption of an eCDSS to address
        the risk of stroke in people with AF and co-morbid mental illness presents a unique
        opportunity for research but requires evidence of acceptability and feasibility.
  
        This study aims to establish the feasibility and acceptability of an eCDSS
        (Cogstack@Maudsley) for AF-related stroke prevention in Mental Health of Older Adults
        inpatient wards.
  
        First, we will conduct surveys and interviews with clinicians on inpatient wards to scope
        experiences of managing atrial fibrillation in secondary mental healthcare settings and
        attitudes towards use of digital technologies to aid in clinical decision making. A
        feasibility study will then be run to evaluate the acceptability and feasibility of
        implementing eCDSS on inpatient wards. Finally, participating clinicians will be invited to
        take part in a survey and interview which will explore their experiences and attitudes
        towards using the eCDSS.
  Cardiovascular diseases are the leading cause of premature mortality in people with serious
        mental illness (SMI) (such as schizophrenia, bipolar disorder, and schizoaffective disorder)
        and dementia. Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is
        associated with fivefold increased risk of stroke also contributing to heart failure and
        death.
  
        According to the National Institute for Health and Care Excellence (NICE) guidelines, the
        management of AF requires a comprehensive assessment of risk factors for thromboembolic
        (using the CHAD2AD2-VASc tool) and bleeding events (using ORBIT or HAS-BLED tools), and
        long-term treatment with oral anticoagulants (OAC) when appropriate.
  
        Although oral anticoagulation has been effective in reducing the risk of stroke in people
        with AF, underuse continues to be reported, especially in patients with co-morbid SMI and/or
        dementia.
  
        The primary objective of this study is to establish the feasibility and acceptability of an
        eCDSS compromising a real-time computerised alerting and clinical decision support system for
        AF-related stroke prevention in secondary mental healthcare. We will conduct a process
        evaluation to assess the barriers, facilitators, and unintended consequences of implementing
        the system onto an inpatient mental health of older adult ward. Data gathered from this study
        will allow us to refine the system, address potential problems with future successful
        implementation, and inform larger trials.
  
        This feasibility study will be conducted over a period of 3 months in Mental Health of Older
        Adults inpatient wards at South London and Maudsley NHS Foundation Trust.
  
        Wards participating in the study will receive the electronic clinical decision support system
        (eCDSS) with clinicians being the end-users.
  
        The key digital tool to be used for eCDSS in this study is CogStack which is an open source
        information retrieval and extraction system with the capability to offer near real-time
        natural language processing (NLP) of electronic health records. The eCDSS will alert
        clinicians if patients with documented atrial fibrillation are admitted to the hospital under
        their care. Alerts will be triggered by the presence of old or new diagnosis of atrial
        fibrillation (AF) on the electronic health records.
  
        The eCDSS will consist of prompts appearing on patients' electronic health records asking
        clinicians to clinically assess the risk of stroke (using CHAD2AD2-VASc tool) and the risk of
        bleeding (using the ORBIT tool) and record the scores in clinical notes.
  observational model: Other
  time perspective: Prospective
  measure: feasibility and acceptability of the eCDSS
  time frame: before and 3 months post intervention
  description: Acceptability - Extent to which eCDSS is perceived by clinician users to be appropriate and acceptable in prompting evidence-based atrial fibrillation management, and an effective system for improving atrial fibrillation care (measured by qualitative methods - pre- and post- survey and semi-structured interviews).
  Feasibility - Ability to recruit wards and clinicians to the study (measured by retention and participation of clinicians on recruited wards through to end of study)
  intervention type: Other
  intervention name: electronic clinical decision support system
  description: eCDSS will alert clinicians if patients with documented atrial fibrillation are admitted to the hospital under their care.
  The eCDSS will consist of prompts appearing on patients' electronic health records asking clinicians to clinically assess the risk of stroke (using CHAD2AD2-VASc tool) and the risk of bleeding (using the ORBIT tool) and record the scores on ePJS. Recommendations include reviewing the stroke and bleeding scores in specific cases, referral to an anticoagulation clinic to reduce AF related stroke risk (a referral template and emails/ telephone of the OAC clinics will be provided) and managing modifiable bleeding risk factors.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Atrial Fibrillation
  sharing ipd: No