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/NCT06037096</url>
    </required_header>
    <id_info>
      <org_study_id>Attend-PE</org_study_id>
      <nct_id>NCT06037096</nct_id>
    </id_info>
    <brief_title>Implementation of a Structured Post-pulmonary Embolism Follow-up Model</brief_title>
    <official_title>Implementation of a Structured Post-pulmonary Embolism Follow-up Model in a Danish Hospital Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aalborg University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Aalborg University Hospital</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>
        Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary&#xD;
        embolism (PE) is the third most common cardiovascular disease and is associated with&#xD;
        substantial short- and long-term morbidity and mortality and high costs of care. In addition&#xD;
        negative physical and mental complications following VTE are common. However in terms of PE,&#xD;
        there are no structured follow-up programs in Denmark and there is considerable variation in&#xD;
        practice patterns of post-PE management both within and between countries.&#xD;
  &#xD;
        The Attend-PE project aims to develop, test and implement a structured follow-up model in a&#xD;
        hospital setting for patients with pulmonary embolism. The Attend-PE is a pre-post&#xD;
        intervention study and will estimate the effectiveness of implementing the structured care&#xD;
        model on a national level.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The pre-post intervention study aims to measure potential change in self-reported and&#xD;
        clinical outcomes before and after the developed Attend-PE follow-up model has been&#xD;
        implemented.&#xD;
  &#xD;
        For the pre-intervention period, patient-reported questionnaires and registry data will be&#xD;
        collected on all persons having received a CT-verified diagnosis of PE in the period March&#xD;
        2022 - March 2023. At 6 and 12 months following the PE event, the patients will receive an&#xD;
        online letter with an invitation to complete an online questionnaire. The questionnaire&#xD;
        includes validated patient-reported outcome measures and questions about sociodemographic&#xD;
        factors. Furthermore, for all patients who have been invited to participate, register data&#xD;
        will be retrieved on use of health care services, sick leave, prescription medication, as&#xD;
        well as information on hospital of admission. Thus, the last PROM and register data for the&#xD;
        12-month follow-up will be retrieved in March 2024.&#xD;
  &#xD;
        From April 2023 - September 2023 implementation of the Attend-PE model takes place on a&#xD;
        national level, with a project team managing training of personnel and supporting the&#xD;
        re-organization of care at the participating hospitals. 18 Danish hospitals have agreed to&#xD;
        participate.&#xD;
  &#xD;
        Following the implementation of the Attend-PE model, the post-intervention period is&#xD;
        initiated. From September 2023 - September 2024 a data collection period similar to the&#xD;
        pre-intervention period will take place, with patient-reported questionnaires forwarded to&#xD;
        patients following a diagnosis of PE at 6 and 12 months, and data from registries being&#xD;
        collected in the same time period. Thus, the last 12-month follow-up is expected to be&#xD;
        completed in September 2025.&#xD;
  &#xD;
        Detailed description of Attend-PE model:&#xD;
  &#xD;
          -  During hospitalization patients are given standardized patient information. This&#xD;
             includes a written leaflet, oral information and links for online information (e.g.,&#xD;
             videos). An assessment of need for cancer screening is made, and in case of symptomatic&#xD;
             DVT compressions stockings are provided. Before discharge patients are referred to a VTE&#xD;
             clinic.&#xD;
  &#xD;
          -  Following discharge, patients and their relatives are invited to participate in a 2-hour&#xD;
             group-based patient education session, ideally taking place within the first 2 weeks&#xD;
             after discharge. This is managed by a nurse, physician and/or allied health professional&#xD;
             and includes education about the condition, treatment, symptom management, physical and&#xD;
             mental health, importance of physical activity and social support, and an overview of&#xD;
             the care pathway. Time is given for questions and discussion with peers.&#xD;
  &#xD;
          -  Following the patient education, an individual follow-up consultation is offered,&#xD;
             depending on an assessment of the individual patient's needs. This allows for a&#xD;
             recapitulation of the previous information given, and specific questions or worries&#xD;
             related to the individual patients' situation.&#xD;
  &#xD;
          -  At three months' post-discharge, patients are invited for a consultation with a&#xD;
             physician at the VTE clinic. Prior to the consultation, the patient completes an online&#xD;
             questionnaire in the waiting room, including validated questionnaires about treatment&#xD;
             satisfaction (Anti-Clot Treatment Scale) and physical and mental wellbeing (Pulmonary&#xD;
             Embolism Quality of Life with cascading questions about dyspnea (MRC), anxiety (GAD-7)&#xD;
             and depression (PHQ-9). The physician uses the patient's responses actively during the&#xD;
             consultation for discussion of continued treatment and assessment of whether further&#xD;
             referral is required, i.e. to physiotherapist for assessment of physical function and&#xD;
             rehabilitation needs, or to the GP for assessment of anxiety or depression and potential&#xD;
             treatment hereof. If CTEPH is suspected, referral for VQ scan and/or echochardiography&#xD;
             is made. Finally, referral for genetic testing may be considered if thrombophilia is&#xD;
             suspected. For patients with provoked PE where medical treatment is completed at 3&#xD;
             months, and where none of the above referrals are required, patients are referred to&#xD;
             their GP with standardized a discharge summary for the GP, and information material for&#xD;
             the patient.&#xD;
  &#xD;
          -  For patients continuing medical treatment, a new consultation with a nurse is planned at&#xD;
             6 months, depending on the patients' needs. Core elements are adjustment of medication&#xD;
             and assessment of physical and psychosocial well-being.&#xD;
  &#xD;
          -  For patients with individual needs due to complex health conditions, frailty, few&#xD;
             psychosocial resources or similar, extra consultations may be provided during follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 15, 2022</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Pre-post intervention study</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>42 item covering health-related quality of life after pulmonary embolism. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in EuroQol 5 Dimensions (EQ-5D)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering general Health in five dimension. The scores fall on a scale of -0.757 (worst health state) to 1.0 (best health state).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Post-VTE Functional Status Scale (PFVS)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering functional status in 5 categories of functional limitations. In total 5 grades of functional limitations, where 1 is the worst grade and 5 is the best grade.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Anti-Clot Treatment Scale (ACTS)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering satisfaction with anticoagulant treatment (12-item ACTS Burdens scale and 3-item ACTS Benefits scale). 5-point to 7-point scales, where higher scores indicate higher satisfaction with treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in General Anxiety Disorder-7 (GAD7)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering anxiety. Score from 0-3 and total score range from 0 to 21, where 21 is the worst outcome and 0 is the best outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering depression. Score from 0-3 and total score range from 0 to 27, where 27 is the worst outcome and 0 is the best outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Patient Activation Measure (PAM)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering individual's knowledge, skills and confidence integral to managing one's own health and healthcare on a 4-point likert scale. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Work Productivity and Activity Impairment questionnaire (WPAI:GH, v2.0.)</measure>
      <time_frame>Change from baseline to 6 month follow-up</time_frame>
      <description>Covering work productivity and activity impairment (6 questions). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Pulmonary Embolism</condition>
    <arm_group>
      <arm_group_label>Attend-PE</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Attend-PE model</intervention_name>
      <description>A pulmonary embolism follow-up care model consisting of structured elements for follow-up after discharge from hospital.</description>
      <arm_group_label>Attend-PE</arm_group_label>
      <other_name>A structured post-pulmonary embolism follow-up model</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  CT-verified diagnosis of PE&#xD;
  &#xD;
            -  Expected survival at least 12 months at the time of PE&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anette A. Højen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aalborg University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Nanna Rolving</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aarhus University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Søren P. Johnsen</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aalborg University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anette A. Højen</last_name>
      <phone>+4529299114</phone>
      <email>a.wind@rn.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stine F. Lindegaard</last_name>
      <phone>+4525545415</phone>
      <email>s.lindegaard@rn.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Aalborg University Hospital</name>
        <address>
          <city>Aalborg</city>
          <zip>9000</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anette A. Højen</last_name>
        <phone>+4529299114</phone>
        <email>a.wind@rn.dk</email>
      </contact>
      <contact_backup>
        <last_name>Stine F. Lindegaard</last_name>
        <phone>+4525545415</phone>
        <email>s.lindegaard@rn.dk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aalborg University Hospital</investigator_affiliation>
      <investigator_full_name>Stine Foged Lindegaard</investigator_full_name>
      <investigator_title>Research assistant, Cand.scient.san.publ</investigator_title>
    </responsible_party>
    <keyword>Implementation</keyword>
    <keyword>Health related quality of life</keyword>
    <keyword>Intervention</keyword>
    <keyword>Pulmonary embolism</keyword>
    <keyword>Health care model</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pulmonary Embolism</mesh_term>
      <mesh_term>Embolism</mesh_term>
    </condition_browse>
    <!-- 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/NCT06037096
  org study id: Attend-PE
  nct id: NCT06037096
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary
        embolism (PE) is the third most common cardiovascular disease and is associated with
        substantial short- and long-term morbidity and mortality and high costs of care. In addition
        negative physical and mental complications following VTE are common. However in terms of PE,
        there are no structured follow-up programs in Denmark and there is considerable variation in
        practice patterns of post-PE management both within and between countries.
  
        The Attend-PE project aims to develop, test and implement a structured follow-up model in a
        hospital setting for patients with pulmonary embolism. The Attend-PE is a pre-post
        intervention study and will estimate the effectiveness of implementing the structured care
        model on a national level.
  The pre-post intervention study aims to measure potential change in self-reported and
        clinical outcomes before and after the developed Attend-PE follow-up model has been
        implemented.
  
        For the pre-intervention period, patient-reported questionnaires and registry data will be
        collected on all persons having received a CT-verified diagnosis of PE in the period March
        2022 - March 2023. At 6 and 12 months following the PE event, the patients will receive an
        online letter with an invitation to complete an online questionnaire. The questionnaire
        includes validated patient-reported outcome measures and questions about sociodemographic
        factors. Furthermore, for all patients who have been invited to participate, register data
        will be retrieved on use of health care services, sick leave, prescription medication, as
        well as information on hospital of admission. Thus, the last PROM and register data for the
        12-month follow-up will be retrieved in March 2024.
  
        From April 2023 - September 2023 implementation of the Attend-PE model takes place on a
        national level, with a project team managing training of personnel and supporting the
        re-organization of care at the participating hospitals. 18 Danish hospitals have agreed to
        participate.
  
        Following the implementation of the Attend-PE model, the post-intervention period is
        initiated. From September 2023 - September 2024 a data collection period similar to the
        pre-intervention period will take place, with patient-reported questionnaires forwarded to
        patients following a diagnosis of PE at 6 and 12 months, and data from registries being
        collected in the same time period. Thus, the last 12-month follow-up is expected to be
        completed in September 2025.
  
        Detailed description of Attend-PE model:
  
          -  During hospitalization patients are given standardized patient information. This
             includes a written leaflet, oral information and links for online information (e.g.,
             videos). An assessment of need for cancer screening is made, and in case of symptomatic
             DVT compressions stockings are provided. Before discharge patients are referred to a VTE
             clinic.
  
          -  Following discharge, patients and their relatives are invited to participate in a 2-hour
             group-based patient education session, ideally taking place within the first 2 weeks
             after discharge. This is managed by a nurse, physician and/or allied health professional
             and includes education about the condition, treatment, symptom management, physical and
             mental health, importance of physical activity and social support, and an overview of
             the care pathway. Time is given for questions and discussion with peers.
  
          -  Following the patient education, an individual follow-up consultation is offered,
             depending on an assessment of the individual patient's needs. This allows for a
             recapitulation of the previous information given, and specific questions or worries
             related to the individual patients' situation.
  
          -  At three months' post-discharge, patients are invited for a consultation with a
             physician at the VTE clinic. Prior to the consultation, the patient completes an online
             questionnaire in the waiting room, including validated questionnaires about treatment
             satisfaction (Anti-Clot Treatment Scale) and physical and mental wellbeing (Pulmonary
             Embolism Quality of Life with cascading questions about dyspnea (MRC), anxiety (GAD-7)
             and depression (PHQ-9). The physician uses the patient's responses actively during the
             consultation for discussion of continued treatment and assessment of whether further
             referral is required, i.e. to physiotherapist for assessment of physical function and
             rehabilitation needs, or to the GP for assessment of anxiety or depression and potential
             treatment hereof. If CTEPH is suspected, referral for VQ scan and/or echochardiography
             is made. Finally, referral for genetic testing may be considered if thrombophilia is
             suspected. For patients with provoked PE where medical treatment is completed at 3
             months, and where none of the above referrals are required, patients are referred to
             their GP with standardized a discharge summary for the GP, and information material for
             the patient.
  
          -  For patients continuing medical treatment, a new consultation with a nurse is planned at
             6 months, depending on the patients' needs. Core elements are adjustment of medication
             and assessment of physical and psychosocial well-being.
  
          -  For patients with individual needs due to complex health conditions, frailty, few
             psychosocial resources or similar, extra consultations may be provided during follow-up.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Pre-post intervention study
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Change in The Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
  time frame: Change from baseline to 6 month follow-up
  description: 42 item covering health-related quality of life after pulmonary embolism. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.
  measure: Change in EuroQol 5 Dimensions (EQ-5D)
  time frame: Change from baseline to 6 month follow-up
  description: Covering general Health in five dimension. The scores fall on a scale of -0.757 (worst health state) to 1.0 (best health state).
  measure: Change in Post-VTE Functional Status Scale (PFVS)
  time frame: Change from baseline to 6 month follow-up
  description: Covering functional status in 5 categories of functional limitations. In total 5 grades of functional limitations, where 1 is the worst grade and 5 is the best grade.
  measure: Change in Anti-Clot Treatment Scale (ACTS)
  time frame: Change from baseline to 6 month follow-up
  description: Covering satisfaction with anticoagulant treatment (12-item ACTS Burdens scale and 3-item ACTS Benefits scale). 5-point to 7-point scales, where higher scores indicate higher satisfaction with treatment.
  measure: Change in General Anxiety Disorder-7 (GAD7)
  time frame: Change from baseline to 6 month follow-up
  description: Covering anxiety. Score from 0-3 and total score range from 0 to 21, where 21 is the worst outcome and 0 is the best outcome.
  measure: Change in Patient Health Questionnaire (PHQ-9)
  time frame: Change from baseline to 6 month follow-up
  description: Covering depression. Score from 0-3 and total score range from 0 to 27, where 27 is the worst outcome and 0 is the best outcome.
  measure: Change in Patient Activation Measure (PAM)
  time frame: Change from baseline to 6 month follow-up
  description: Covering individual's knowledge, skills and confidence integral to managing one's own health and healthcare on a 4-point likert scale. Transformed scale show score from 0-100, where 0 is the worst outcome and 100 is the best outcome.
  measure: Change in Work Productivity and Activity Impairment questionnaire (WPAI:GH, v2.0.)
  time frame: Change from baseline to 6 month follow-up
  description: Covering work productivity and activity impairment (6 questions). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
  arm group label: Attend-PE
  arm group type: Experimental
  intervention type: Other
  intervention name: Attend-PE model
  description: A pulmonary embolism follow-up care model consisting of structured elements for follow-up after discharge from hospital.
  arm group label: Attend-PE
  other name: A structured post-pulmonary embolism follow-up model
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anette A. Højen
  role: Principal Investigator
  affiliation: Aalborg University Hospital
  last name: Nanna Rolving
  role: Principal Investigator
  affiliation: Aarhus University Hospital
  last name: Søren P. Johnsen
  role: Principal Investigator
  affiliation: Aalborg University
  last name: Anette A. Højen
  phone: +4529299114
  email: a.wind@rn.dk
  last name: Stine F. Lindegaard
  phone: +4525545415
  email: s.lindegaard@rn.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Aalborg University Hospital
  investigator full name: Stine Foged Lindegaard
  investigator title: Research assistant, Cand.scient.san.publ
  mesh term: Pulmonary Embolism
  mesh term: Embolism