<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/NCT03302572</url>
  </required_header>
  <id_info>
    <org_study_id>15/101</org_study_id>
    <nct_id>NCT03302572</nct_id>
  </id_info>
  <brief_title>Effectiveness Brief Information Advanced Directives Primary Care</brief_title>
  <official_title>Effectiveness of a Brief Information About Advanced Directives in Primary Care: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina</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>
      The knowledge and completion of advanced directives (ADs) by the population is generally low.&#xD;
      Primary care could develop a very important role to inform and assist in the preparation of&#xD;
      this document because of its accessibility.&#xD;
&#xD;
      Objective: To evaluate the effectiveness of an oral brief information and a brochure&#xD;
      administered in primary care to improve the proportion of ADs records.&#xD;
&#xD;
      Design: Randomized clinical trial. Ambit: 7 offices from a urban health center which serves&#xD;
      about 25,000 users older than 18 years.&#xD;
&#xD;
      Material and methods It will be administered randomly triptych and oral brief information&#xD;
      about the existence of advance directives for people over 18 to attend the appointment of&#xD;
      their family doctor for any reason (intervention group). It will be given the possibility of&#xD;
      more extensive information if they wish and collaboration will be offered for the advance&#xD;
      directive according to patient preferences. The control group will not receive any&#xD;
      information. Follow-up: 3 months. Variables will be: number of people interested in ADs,&#xD;
      number of ADs made and demographic data (gender, age, education level, race, comorbidities,&#xD;
      religion, testament) in both groups. Statistical analysis: multiple linear regression,&#xD;
      Poisson and Cox as response analyzed, with the intervention/control group as the main&#xD;
      variable adjusting for potential confounders. Bivariate comparison using Student t test or&#xD;
      Mann-Whitney test (continuous variables) and chi-square or Fisher's exact test (categorical&#xD;
      variables). 165 subjects were required in the control group and 165 in the intervention&#xD;
      group.&#xD;
&#xD;
      Conclusion: positive results of this study will bring out the brief information managed by&#xD;
      family physicians increases the number of ADs thus facilitating the right to autonomy of the&#xD;
      patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 3, 2016</start_date>
  <completion_date type="Anticipated">March 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2018</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interest in or performance of advance directives</measure>
    <time_frame>In 3 months</time_frame>
    <description>Proportion of people interested in or performance of Advance Directives in 3 months in the adult population. They will be obtained at the moment that the patient shows interest in the intervention of when they performance the Advance Directives, or if not, by asking by appointment or by telephone within 3 months of their recruitment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline characteristics of those who perform or are interested in Advanced Directives</measure>
    <time_frame>In 3 months</time_frame>
    <description>Evaluate the baseline characteristics of those who perform or are interested in Advanced Directives (whether they are in the control or intervention group).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline characteristics of those performing Advanced directives in intervention group</measure>
    <time_frame>In 3 months</time_frame>
    <description>To assess the baseline characteristics of those performing the Advanced Directives and those not within the intervention group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons to performance Advanced directives</measure>
    <time_frame>In 3 months</time_frame>
    <description>Evaluate the reasons why patients finally formalize the document by open question (will be categorized if there is a limited number of responses, otherwise the reasons will be described qualitatively).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">330</enrollment>
  <condition>Primary Care</condition>
  <condition>Advance Directives</condition>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>Brief information group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be given brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who fall into a control group will only be attended to their reason for visiting and will be asked for the necessary data to obtain the independent variables if they do not appear in their history. If the patient in this group wants the information, he will be excluded from the study because he &quot;refuses to participate.&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brief information group</intervention_name>
    <description>Patients will be given oral brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.</description>
    <arm_group_label>Brief information group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years old who go to their family doctor by appointment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Patients with language barrier&#xD;
&#xD;
          -  Patients younger than 18 years (advanced directives not provided for by law)&#xD;
&#xD;
          -  Patients with altered decision-making ability according to computerized clinical&#xD;
             history by coding in health problems or mentioned in a clinical course of computerized&#xD;
             medical history : cognitive impairment, dementia, mental retardation diagnosed.&#xD;
             Although there are studies on attitudes towards advanced directives of people with&#xD;
             early cognitive impairment (Minimental&gt; 18), it was decided to discard because the&#xD;
             intervention should be brief. The cited study also concludes that this type of&#xD;
             patients prefer to delegate decisions to the family.&#xD;
&#xD;
          -  Patients who come spontaneously to their family doctor.&#xD;
&#xD;
          -  Patients who have already been recruited previously in the study. Patients who may&#xD;
             visit by appointment only on more than one occasion will only participate once and&#xD;
             subsequent visits for recruitment will be excluded. In addition, there will be no&#xD;
             reinforcement of the study intervention in these visits.&#xD;
&#xD;
          -  Patients who have already formalized the advanced directives.&#xD;
&#xD;
          -  Patients who do not wish to participate in the study.&#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>Yolanda Rando</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Català de la Salut</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yolanda Rando</last_name>
    <phone>+34616678030</phone>
    <email>yolanrando@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institu Català de la Salut</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <state>Barcelona</state>
        <zip>08905</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yolanda Rando</last_name>
      <phone>+34616678030</phone>
      <email>yolanrando@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 4, 2017</last_update_submitted>
  <last_update_submitted_qc>October 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>primary care</keyword>
  <keyword>advance directives</keyword>
  <keyword>randomized controlled trial</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>For confidentiality</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03302572/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03302572/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03302572
org study id: 15/101
nct id: NCT03302572
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The knowledge and completion of advanced directives (ADs) by the population is generally low.
      Primary care could develop a very important role to inform and assist in the preparation of
      this document because of its accessibility.

      Objective: To evaluate the effectiveness of an oral brief information and a brochure
      administered in primary care to improve the proportion of ADs records.

      Design: Randomized clinical trial. Ambit: 7 offices from a urban health center which serves
      about 25,000 users older than 18 years.

      Material and methods It will be administered randomly triptych and oral brief information
      about the existence of advance directives for people over 18 to attend the appointment of
      their family doctor for any reason (intervention group). It will be given the possibility of
      more extensive information if they wish and collaboration will be offered for the advance
      directive according to patient preferences. The control group will not receive any
      information. Follow-up: 3 months. Variables will be: number of people interested in ADs,
      number of ADs made and demographic data (gender, age, education level, race, comorbidities,
      religion, testament) in both groups. Statistical analysis: multiple linear regression,
      Poisson and Cox as response analyzed, with the intervention/control group as the main
      variable adjusting for potential confounders. Bivariate comparison using Student t test or
      Mann-Whitney test (continuous variables) and chi-square or Fisher's exact test (categorical
      variables). 165 subjects were required in the control group and 165 in the intervention
      group.

      Conclusion: positive results of this study will bring out the brief information managed by
      family physicians increases the number of ADs thus facilitating the right to autonomy of the
      patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Interest in or performance of advance directives
time frame: In 3 months
description: Proportion of people interested in or performance of Advance Directives in 3 months in the adult population. They will be obtained at the moment that the patient shows interest in the intervention of when they performance the Advance Directives, or if not, by asking by appointment or by telephone within 3 months of their recruitment
measure: Baseline characteristics of those who perform or are interested in Advanced Directives
time frame: In 3 months
description: Evaluate the baseline characteristics of those who perform or are interested in Advanced Directives (whether they are in the control or intervention group).
measure: Baseline characteristics of those performing Advanced directives in intervention group
time frame: In 3 months
description: To assess the baseline characteristics of those performing the Advanced Directives and those not within the intervention group
measure: Reasons to performance Advanced directives
time frame: In 3 months
description: Evaluate the reasons why patients finally formalize the document by open question (will be categorized if there is a limited number of responses, otherwise the reasons will be described qualitatively).
arm group label: Brief information group
arm group type: Experimental
description: Patients will be given brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.
arm group label: Control group
arm group type: No Intervention
description: Patients who fall into a control group will only be attended to their reason for visiting and will be asked for the necessary data to obtain the independent variables if they do not appear in their history. If the patient in this group wants the information, he will be excluded from the study because he "refuses to participate."
intervention type: Other
intervention name: Brief information group
description: Patients will be given oral brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.
arm group label: Brief information group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yolanda Rando
role: Principal Investigator
affiliation: Institut Català de la Salut
last name: Yolanda Rando
phone: +34616678030
email: yolanrando@gmail.com
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Sponsor
sharing ipd: No
ipd description: For confidentiality
provided document: 
provided document: 