<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/NCT02210442</url>
  </required_header>
  <id_info>
    <org_study_id>11/0047</org_study_id>
    <nct_id>NCT02210442</nct_id>
  </id_info>
  <brief_title>Effectiveness of Educational Games to Implementation Clinical Practice Guidelines to Family Medicine Residents in Spain.</brief_title>
  <acronym>EDUCAGUIA</acronym>
  <official_title>Educaguia Project: Clinical Trial, Randomised by Clusters, to Assess the Effectiveness of a Strategy With Educational Games to Implementation pf Clinical Practice Guidelines to Family Medicine Residents in Spain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gerencia de Atención Primaria, Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondo de Investigacion Sanitaria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gerencia de Atención Primaria, Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter study to evaluate the effectiveness of a teaching strategy based on the&#xD;
      incorporation of educational games with simulated settings versus usual practice based on&#xD;
      diffusion for the implementation of clinical practice guidelines in Family Medicine Residency&#xD;
      Program. The impact of the new strategy will be measured in improving knowledge and skill&#xD;
      acquisition in clinical decision making of Family Medicine Residency Program after 6 months.&#xD;
      Effectiveness will also be measured a month and 12 months after intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To evaluate the effectiveness of educational games to implementation practice&#xD;
      guidelines to acquire skills in clinical decision-making by family medicine residents in&#xD;
      Spain.&#xD;
&#xD;
      Secondary objectives: To describe the strategies utilized in Residency Program in Family&#xD;
      Medicine in Spain to teach the use of practice guidelines. To identify barriers and&#xD;
      facilitators for the use of practice guidelines for family medicine residents.&#xD;
&#xD;
      Setting: Unit Family Medicine in Spain. Study design: Multicentric cluster randomised&#xD;
      controlled clinical trial. Population: Family Medicine Residents of second and third year.&#xD;
      Sample size: 394 residents (197 in each arm). The randomization units will be units&#xD;
      (clusters). The units of analysis are professionals (residents). Variables: Main outcome&#xD;
      variable measured in both groups: assess of skill levels and number of correct answers about&#xD;
      clinical questions in diabetes, anxiety disorders, antibiotic prescription and insomnia&#xD;
      clinical practice guidelines in primary care.&#xD;
&#xD;
      Sociodemographic variables and educational variables for each subject and variables regarding&#xD;
      Residency Program in Family Medicine.&#xD;
&#xD;
      Intervention: EDUCAGUIA plan. Incorporating educational games online for each guideline.&#xD;
&#xD;
      Statistical Analysis: Primary and secondary effectiveness. Adjusting by contextual and&#xD;
      individual variables factors with mixed effects models (lineal regression) (dependent&#xD;
      variable: points obtained in educational games in each guide).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessing clinical decision-making skills</measure>
    <time_frame>Change from Baseline skills at 6 months</time_frame>
    <description>Outcomes of a test designed to assess problem solving and clinical decision making skills about anxiety disorders, diabetes, insomnia and prescription antibiotics prescription after six months after intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing clinical decision-making skills</measure>
    <time_frame>Change from Baseline at 1 month and 12 months</time_frame>
    <description>Outcomes of a test designed to assess problem solving and clinical decision making skills about anxiety disorders, diabetes, insomnia and prescription antibiotics prescription after 1 month and 12 months after intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Educaguia intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implementation of practice clinical guidelines with educational games</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implementation of clinical practice guidelines with standard practice care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>educaguia intervention</intervention_name>
    <description>Health professionals (residents) play with educational games in order to acquire knowledge and skill about management of clinical practice guidelines.</description>
    <arm_group_label>Educaguia intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control group</intervention_name>
    <description>Health professional will learn how to manage a clinical practice guidelines with standard clinical practice.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Second and third year residents in Family Medicine Program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Giving up the Family Medicine Program.&#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>Isabel del Cura, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reserch Unit. Gerencia de Atención Primaria Madrid, Servicio Madrileño de Salud. Madrid. Spain.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gerencia de Atención Primaria</name>
      <address>
        <city>Madrid</city>
        <zip>28035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Del Cura-Gonzalez I, Lopez-Rodriguez JA, Sanz-Cuesta T, Rodriguez-Barrientos R, Martin-Fernandez J, Ariza-Cardiel G, Polentinos-Castro E, Roman-Crespo B, Escortell-Mayor E, Rico-Blazquez M, Hernandez-Santiago V, Azcoaga-Lorenzo A, Ojeda-Ruiz E, Gonzalez-Gonzalez AI, Avila-Tomas JF, Barrio-Cortes J, Molero-Garcia JM, Ferrer-Pena R, Tello-Bernabe ME, Trujillo-Martin M; Educaguia Group. Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters. Implement Sci. 2016 May 17;11:71. doi: 10.1186/s13012-016-0425-3.</citation>
    <PMID>27189180</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>April 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>February 6, 2018</last_update_submitted>
  <last_update_submitted_qc>February 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gerencia de Atención Primaria, Madrid</investigator_affiliation>
    <investigator_full_name>Isabel Del Cura-Gonzalez</investigator_full_name>
    <investigator_title>PhD. MD</investigator_title>
  </responsible_party>
  <keyword>educational games</keyword>
  <keyword>clinical practice guideline</keyword>
  <keyword>family medicine</keyword>
  <keyword>primary health care</keyword>
  <keyword>cluster clinical trial</keyword>
  <!-- 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/NCT02210442
org study id: 11/0047
nct id: NCT02210442
lead sponsor: 
collaborator: 
has dmc: No
A multicenter study to evaluate the effectiveness of a teaching strategy based on the
      incorporation of educational games with simulated settings versus usual practice based on
      diffusion for the implementation of clinical practice guidelines in Family Medicine Residency
      Program. The impact of the new strategy will be measured in improving knowledge and skill
      acquisition in clinical decision making of Family Medicine Residency Program after 6 months.
      Effectiveness will also be measured a month and 12 months after intervention.
Objective: To evaluate the effectiveness of educational games to implementation practice
      guidelines to acquire skills in clinical decision-making by family medicine residents in
      Spain.

      Secondary objectives: To describe the strategies utilized in Residency Program in Family
      Medicine in Spain to teach the use of practice guidelines. To identify barriers and
      facilitators for the use of practice guidelines for family medicine residents.

      Setting: Unit Family Medicine in Spain. Study design: Multicentric cluster randomised
      controlled clinical trial. Population: Family Medicine Residents of second and third year.
      Sample size: 394 residents (197 in each arm). The randomization units will be units
      (clusters). The units of analysis are professionals (residents). Variables: Main outcome
      variable measured in both groups: assess of skill levels and number of correct answers about
      clinical questions in diabetes, anxiety disorders, antibiotic prescription and insomnia
      clinical practice guidelines in primary care.

      Sociodemographic variables and educational variables for each subject and variables regarding
      Residency Program in Family Medicine.

      Intervention: EDUCAGUIA plan. Incorporating educational games online for each guideline.

      Statistical Analysis: Primary and secondary effectiveness. Adjusting by contextual and
      individual variables factors with mixed effects models (lineal regression) (dependent
      variable: points obtained in educational games in each guide).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Assessing clinical decision-making skills
time frame: Change from Baseline skills at 6 months
description: Outcomes of a test designed to assess problem solving and clinical decision making skills about anxiety disorders, diabetes, insomnia and prescription antibiotics prescription after six months after intervention.
measure: Assessing clinical decision-making skills
time frame: Change from Baseline at 1 month and 12 months
description: Outcomes of a test designed to assess problem solving and clinical decision making skills about anxiety disorders, diabetes, insomnia and prescription antibiotics prescription after 1 month and 12 months after intervention.
arm group label: Educaguia intervention
arm group type: Experimental
description: Implementation of practice clinical guidelines with educational games
arm group label: Control group
arm group type: Active Comparator
description: Implementation of clinical practice guidelines with standard practice care
intervention type: Behavioral
intervention name: educaguia intervention
description: Health professionals (residents) play with educational games in order to acquire knowledge and skill about management of clinical practice guidelines.
arm group label: Educaguia intervention
intervention type: Other
intervention name: control group
description: Health professional will learn how to manage a clinical practice guidelines with standard clinical practice.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Isabel del Cura, MD PhD
role: Principal Investigator
affiliation: Reserch Unit. Gerencia de Atención Primaria Madrid, Servicio Madrileño de Salud. Madrid. Spain.
facility: 
country: Spain
citation: Del Cura-Gonzalez I, Lopez-Rodriguez JA, Sanz-Cuesta T, Rodriguez-Barrientos R, Martin-Fernandez J, Ariza-Cardiel G, Polentinos-Castro E, Roman-Crespo B, Escortell-Mayor E, Rico-Blazquez M, Hernandez-Santiago V, Azcoaga-Lorenzo A, Ojeda-Ruiz E, Gonzalez-Gonzalez AI, Avila-Tomas JF, Barrio-Cortes J, Molero-Garcia JM, Ferrer-Pena R, Tello-Bernabe ME, Trujillo-Martin M; Educaguia Group. Effectiveness of a strategy that uses educational games to implement clinical practice guidelines among Spanish residents of family and community medicine (e-EDUCAGUIA project): a clinical trial by clusters. Implement Sci. 2016 May 17;11:71. doi: 10.1186/s13012-016-0425-3.
PMID: 27189180
responsible party type: Principal Investigator
investigator affiliation: Gerencia de Atención Primaria, Madrid
investigator full name: Isabel Del Cura-Gonzalez
investigator title: PhD. MD