<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/NCT03775551</url>
  </required_header>
  <id_info>
    <org_study_id>C-RG-E1560-P002</org_study_id>
    <secondary_id>20180328</secondary_id>
    <nct_id>NCT03775551</nct_id>
  </id_info>
  <brief_title>Counter-referral System Improvement Collaborative</brief_title>
  <acronym>BIDCR-R</acronym>
  <official_title>Evaluation of the Effectiveness of an Improvement Collaborative Strategy to Improve the Counter-referral System of Patients With Cardiovascular Disease in the Public Healthcare Sector in Argentina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Clinical Effectiveness and Health Policy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Public Health, Argentina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Clinical Effectiveness and Health Policy</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>
      Coordination between different levels of care has been identified as one of the main&#xD;
      components of care among people with chronic diseases. In this sense, an adequate referral&#xD;
      and counter-reference system facilitates the management of the care process with timely&#xD;
      access to the required referral. The objective of this project is to evaluate the&#xD;
      effectiveness of a multicomponent strategy that improves the counter- referral process in&#xD;
      patients with cardiovascular diseases in the public health system.&#xD;
&#xD;
      Population: The study will be carried out in selected hospitals of the provinces of Mendoza,&#xD;
      Tucumán and Salta in Argentina. Patients who have been hospitalized with a diagnosis of heart&#xD;
      failure, hypertension (requires hospitalization) and / or coronary disease (unstable angina)&#xD;
      will be included.&#xD;
&#xD;
      Design and methods: a Randomized clinical study by clusters. 10 hospital will be included: 5&#xD;
      will be randomly assigned to receive an intervention to increase the improve counter referral&#xD;
      rates (improvement cycles) and 5 to the control branch (usual care). 51 participants will be&#xD;
      included in each hospital, in total, 510 participants.&#xD;
&#xD;
      Intervention: An innovative vision is proposed, which combines a participatory and dynamic&#xD;
      methodology based on improvement cycles. This approach includes the implementation of&#xD;
      participatory learning sessions for health providers, involving the effectors of the design&#xD;
      of the intervention. In the intervention branch at least 6 workshops (sessions) will be held&#xD;
      with the members of the care system, in order to identify opportunities for improvement&#xD;
      oriented to the design and application of an innovative intervention based on best practices.&#xD;
      Each one of the sessions will constitute an analysis of the improvement cycle, following the&#xD;
      following steps: 1) Selection of participants of the initial workshop; 2) Development of work&#xD;
      model based on bibliographic review and initial qualitative phase; 3) Initial workshop with&#xD;
      effectors for training in continuous improvement, objectives, interventions and data&#xD;
      collection; 4) Learning workshops to discuss results, applicability of interventions and&#xD;
      modifications to the work plan; 5) Closing session to evaluate preliminary results and&#xD;
      discuss continuity of interventions beyond the project.&#xD;
&#xD;
      Outcomes: 1) consultation in the PHC after hospital discharge; 2) readmission's; 3)&#xD;
      consultations in the hospital; 4) follow-up in the PHC; 5) patient perspective&#xD;
      (satisfaction).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 8, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients visits in a primary health center (PHC) after hospital discharge</measure>
    <time_frame>3 months after enrollment and/or end of study</time_frame>
    <description>proportion of visits made in a primary care center (PHC) after hospital discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effective counter reference performed by physicians</measure>
    <time_frame>3 months after enrollment and/or end of study</time_frame>
    <description>proportion of documented ( written) counter references by hospital physicians to a PHC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to the first consultation in a PHC after the hospital discharge</measure>
    <time_frame>3 months after enrollment and/or .end of study</time_frame>
    <description>mean number of days upon patient hospital discharged to the first visit in a primary care center</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular hospital readmission's</measure>
    <time_frame>3 months after enrollment and/or end of study</time_frame>
    <description>proportion of re-admissions for the same primary admission condition for which the patient was discharged within the first 90 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular re consultations at the second level of care</measure>
    <time_frame>3 months after enrollment and/or end of study</time_frame>
    <description>proportions of cardiovascular consultations at the secondary level of care after hospital discharge that should have been performed at the first level of care related to the condition for which the patient was included and admitted to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients satisfaction with the primary health level measured by adapted PCAT questions</measure>
    <time_frame>4 months</time_frame>
    <description>patients satisfaction with the health care provided at the PHC measured by adapted PTCA questions. The Primary Care Assessment Tool was design to evaluate attainment of features in primary care settings. Attributes identified by the tool are first contact accessibility and use, continuity, and coordination in the primary level. The tool has been adapted and validated in several countries and settings. The global index for evaluation will be composed as the sum of 10 items, ranging from 10 to 40. To facilitate interpretation the score will be transformed to a scale of 0 -100 points ( score =100 x (sum -10)/40-10), with higher score indicating more favorable satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">510</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Quality Improvement</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants belonging to the hospitals assigned to the control group the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC following usual practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Improvement cycle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In participants belonging to the hospitals assigned to the intervention group,the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC using innovative intervention to assure continuity of care and assistant level approach. This innovations will be crafted from the rapid improvement cycles considering the environment and key aspects of the every day care at the participating centers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Improvement cycle</intervention_name>
    <description>at least 6 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices.</description>
    <arm_group_label>Improvement cycle</arm_group_label>
    <other_name>quality improvement cycle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects that only have public health coverage or PAMI&#xD;
&#xD;
          -  Adults over 18 year of age&#xD;
&#xD;
          -  Patients admitted to the hospital with diagnosis of: non valvular heart failure and/or&#xD;
             complicated hypertension ( that requires hospitalization) and/or coronary heart&#xD;
             disease ( unstable angina)&#xD;
&#xD;
          -  Residence in the area of influence of the hospitals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Anticoagulated patients&#xD;
&#xD;
          -  People who are immobilized&#xD;
&#xD;
          -  People who do not give their informed consent&#xD;
&#xD;
          -  People who plan to move in the next 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vilma Irazola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical Effectiveness and Health Policy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ezequiel García Elorrio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Clinical Effectiveness and Health Policy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cintia Spira, MD</last_name>
    <phone>+541147778767</phone>
    <phone_ext>16</phone_ext>
    <email>cspira@iecs.org.ar</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital A Italo Perrupato</name>
      <address>
        <city>San Martín</city>
        <state>Mendoza</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gladys Liliana Roggerone, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Teodoro J. Schestakow</name>
      <address>
        <city>San Rafael</city>
        <state>Mendoza</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ethel Larregle</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Antonio J. Scaravelli</name>
      <address>
        <city>Tunuyán</city>
        <state>Mendoza</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carmelo Fazio</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital N. Joaquín Castellano</name>
      <address>
        <city>Güemes</city>
        <state>Salta</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Estelina Aguirre</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Centro de Salud Zenón J. Santillán</name>
      <address>
        <city>Tucumán</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gustavo Paterlini</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Ángel C. Padilla</name>
      <address>
        <city>Tucumán</city>
        <state>Tucuman</state>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paola Ingratta Giangreco</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Central</name>
      <address>
        <city>Mendoza</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raquel Saa, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Luis Lagomaggiore</name>
      <address>
        <city>Mendoza</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jorge Piasentin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Papa Francisco</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Eugenia Lanuza</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital San Bernardo</name>
      <address>
        <city>Salta</city>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>quality improvement</keyword>
  <keyword>collaborative</keyword>
  <keyword>counter reference</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775551
org study id: C-RG-E1560-P002
secondary id: 20180328
nct id: NCT03775551
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coordination between different levels of care has been identified as one of the main
      components of care among people with chronic diseases. In this sense, an adequate referral
      and counter-reference system facilitates the management of the care process with timely
      access to the required referral. The objective of this project is to evaluate the
      effectiveness of a multicomponent strategy that improves the counter- referral process in
      patients with cardiovascular diseases in the public health system.

      Population: The study will be carried out in selected hospitals of the provinces of Mendoza,
      Tucumán and Salta in Argentina. Patients who have been hospitalized with a diagnosis of heart
      failure, hypertension (requires hospitalization) and / or coronary disease (unstable angina)
      will be included.

      Design and methods: a Randomized clinical study by clusters. 10 hospital will be included: 5
      will be randomly assigned to receive an intervention to increase the improve counter referral
      rates (improvement cycles) and 5 to the control branch (usual care). 51 participants will be
      included in each hospital, in total, 510 participants.

      Intervention: An innovative vision is proposed, which combines a participatory and dynamic
      methodology based on improvement cycles. This approach includes the implementation of
      participatory learning sessions for health providers, involving the effectors of the design
      of the intervention. In the intervention branch at least 6 workshops (sessions) will be held
      with the members of the care system, in order to identify opportunities for improvement
      oriented to the design and application of an innovative intervention based on best practices.
      Each one of the sessions will constitute an analysis of the improvement cycle, following the
      following steps: 1) Selection of participants of the initial workshop; 2) Development of work
      model based on bibliographic review and initial qualitative phase; 3) Initial workshop with
      effectors for training in continuous improvement, objectives, interventions and data
      collection; 4) Learning workshops to discuss results, applicability of interventions and
      modifications to the work plan; 5) Closing session to evaluate preliminary results and
      discuss continuity of interventions beyond the project.

      Outcomes: 1) consultation in the PHC after hospital discharge; 2) readmission's; 3)
      consultations in the hospital; 4) follow-up in the PHC; 5) patient perspective
      (satisfaction).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patients visits in a primary health center (PHC) after hospital discharge
time frame: 3 months after enrollment and/or end of study
description: proportion of visits made in a primary care center (PHC) after hospital discharge
measure: Effective counter reference performed by physicians
time frame: 3 months after enrollment and/or end of study
description: proportion of documented ( written) counter references by hospital physicians to a PHC
measure: Time to the first consultation in a PHC after the hospital discharge
time frame: 3 months after enrollment and/or .end of study
description: mean number of days upon patient hospital discharged to the first visit in a primary care center
measure: Cardiovascular hospital readmission's
time frame: 3 months after enrollment and/or end of study
description: proportion of re-admissions for the same primary admission condition for which the patient was discharged within the first 90 days
measure: Cardiovascular re consultations at the second level of care
time frame: 3 months after enrollment and/or end of study
description: proportions of cardiovascular consultations at the secondary level of care after hospital discharge that should have been performed at the first level of care related to the condition for which the patient was included and admitted to the hospital
measure: Patients satisfaction with the primary health level measured by adapted PCAT questions
time frame: 4 months
description: patients satisfaction with the health care provided at the PHC measured by adapted PTCA questions. The Primary Care Assessment Tool was design to evaluate attainment of features in primary care settings. Attributes identified by the tool are first contact accessibility and use, continuity, and coordination in the primary level. The tool has been adapted and validated in several countries and settings. The global index for evaluation will be composed as the sum of 10 items, ranging from 10 to 40. To facilitate interpretation the score will be transformed to a scale of 0 -100 points ( score =100 x (sum -10)/40-10), with higher score indicating more favorable satisfaction.
arm group label: Control
arm group type: No Intervention
description: The participants belonging to the hospitals assigned to the control group the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC following usual practice.
arm group label: Improvement cycle
arm group type: Experimental
description: In participants belonging to the hospitals assigned to the intervention group,the health providers will give feedback on their health condition and will advise on how to follow up their care after discharge or referral back to PHC using innovative intervention to assure continuity of care and assistant level approach. This innovations will be crafted from the rapid improvement cycles considering the environment and key aspects of the every day care at the participating centers.
intervention type: Behavioral
intervention name: Improvement cycle
description: at least 6 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices.
arm group label: Improvement cycle
other name: quality improvement cycle
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vilma Irazola, MD
role: Principal Investigator
affiliation: Institute for Clinical Effectiveness and Health Policy
last name: Ezequiel García Elorrio, PhD
role: Principal Investigator
affiliation: Institute for Clinical Effectiveness and Health Policy
last name: Cintia Spira, MD
phone: +541147778767
phone ext: 16
email: cspira@iecs.org.ar
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
country: Argentina
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
sharing ipd: Undecided