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/NCT06021730</url>
    </required_header>
    <id_info>
      <org_study_id>22072004</org_study_id>
      <nct_id>NCT06021730</nct_id>
    </id_info>
    <brief_title>Impact of After Visit Instructions on Patient Comprehension</brief_title>
    <official_title>Utilization and Utility of Patient After-Visit Instructions at a University Rheumatology Outpatient Clinic: Status and Randomized Prospective Pilot Intervention Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rush University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rush University Medical Center</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>
        This prospective study aims to analyze the influence of standardized after visit instructions&#xD;
        (AVI) and teach back (TB) method on patients' understanding of health information. The study&#xD;
        divided routine clinic patients into three groups: standard care, standardized AVI, and&#xD;
        standardized AVI with TB. Patient health literacy, satisfaction, and AVI comprehension were&#xD;
        gauged through surveys and post-visit follow-up calls. The investigators hypothesized that&#xD;
        there would be an improvement in patient comprehension with the standardized AVI or TB when&#xD;
        compared to controls.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study seeks to investigate the discharge practices of the Rheumatology clinic and&#xD;
        analyze whether variations in these practices impact patient satisfaction, enhance their&#xD;
        comprehension of their disease, and potentially influence the progression of their condition.&#xD;
        Participants agreeing to take part in this study will be engaged for a duration of up to&#xD;
        three (3) weeks, encompassing two study visits-one during their regular clinic appointment&#xD;
        and another through a telephone study visit.&#xD;
  &#xD;
        During the initial in-person visit, participants will complete a health literacy survey&#xD;
        before their appointment and a satisfaction survey afterward. Approximately 1-2 weeks&#xD;
        following the in-person visit, participants will receive a telephone call to respond to&#xD;
        questions regarding their visit. More details of the study are outlined below.&#xD;
  &#xD;
        Prior to commencing the study, participants will be asked to provide their consent by signing&#xD;
        a form indicating their willingness to take part. The participants will then be randomly&#xD;
        allocated to one of three study groups: the Control Group, the After Visit Instructions (AVI)&#xD;
        Group, or the AVI with teach back (TB) group.&#xD;
  &#xD;
        Throughout the course of the study, participants will engage in various activities. First,&#xD;
        they will complete a health literacy form, designed to assess their familiarity with commonly&#xD;
        used terms in rheumatology clinics. This will take place prior to the standard clinic visit&#xD;
        and is expected to last around 5 minutes.&#xD;
  &#xD;
        During the regular clinic visit, participants will follow different protocols based on their&#xD;
        assigned group:&#xD;
  &#xD;
          -  Participants in the Control Group will experience their usual clinic visit.&#xD;
  &#xD;
          -  Those in the AVI Group will receive a personalized set of After Visit Instructions (AVI)&#xD;
             that detail any changes in their care. This additional interaction is anticipated to&#xD;
             last approximately 2 minutes.&#xD;
  &#xD;
          -  Individuals in the AVI with TB Group will be asked to explain, in their own words, the&#xD;
             modifications made during their visit. This interaction is expected to take an extra 1&#xD;
             minute.&#xD;
  &#xD;
        After the clinic visit, all participants will complete a satisfaction survey, assessing both&#xD;
        the provider's performance and their contentment with the discharge process. This survey is&#xD;
        estimated to take around 3 minutes to complete.&#xD;
  &#xD;
        During the follow-up period, participants will receive a phone call 1-2 weeks after their&#xD;
        clinic visit to respond to inquiries regarding their appointment experience and the discharge&#xD;
        process. This telephone interview is anticipated to take around 10 minutes and aims to gather&#xD;
        valuable insights.&#xD;
  &#xD;
        Furthermore, foundational data will be extracted from participants' electronic medical&#xD;
        records. This information will encompass details such as gender, date of birth, ethnicity,&#xD;
        race, specific disease information, ongoing medications, and data from forms filled out&#xD;
        before each visit that provide a comprehensive view of disease activity.&#xD;
  &#xD;
        This study incorporates medical data from electronic medical records while ensuring&#xD;
        confidentiality. Risks include potential loss of privacy, although safeguards are&#xD;
        implemented. The study may extend the clinic visit by a maximum of 15 minutes, with no other&#xD;
        anticipated risks.&#xD;
  &#xD;
        Potential benefits include enhanced discharge practices, including standardized AVI templates&#xD;
        and the &quot;teach back&quot; method, which could improve disease comprehension and management&#xD;
        adherence. However, responses to interventions can vary, so outcomes cannot be&#xD;
        pre-determined.&#xD;
  &#xD;
        Participation in the control group offers no anticipated benefits. This study is not a&#xD;
        treatment study, and the only alternative to participation is non-participation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Actual">May 12, 2023</completion_date>
    <primary_completion_date type="Actual">April 28, 2023</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>Patient Comprehension Survey</measure>
      <time_frame>1-2 weeks after initial visit</time_frame>
      <description>This is a telephone survey that will assess patients comprehension of disease over three main categories: disease state, medication changes, and referral/imaging/lab requests. Each category will be measure concordance of the patients understanding with what was written in the note in the form of a percentage from 0% to 100%. A higher percentage means a better understanding of ones disease.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction Survey</measure>
      <time_frame>Will receive in email or in person immediately after initial visit</time_frame>
      <description>Patient satisfaction will be assessed through a in person or email survey that will assess multiple elements of satisfaction. A higher score indicates a higher level of satisfaction.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">75</enrollment>
    <condition>After Visit Instructions</condition>
    <condition>Patient Education</condition>
    <condition>Teach-Back Communication</condition>
    <condition>Patient Comprehension</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients received standard after visit procedure based on the provider</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standardized After Visit Instructions Only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The standardized after visit instructions (AVI) only group included patients receiving typed standardized AVI which included a text template that providers used to write customized AVI for the patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standardized After Visit Instructions &amp; Teach Back</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The standardized AVI &amp; teach back (TB) group included standardized written AVI with the patient repeating to the provider which changes and future management had been agreed upon during the visit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standardized After Visit Instructions Only</intervention_name>
      <description>The intervention took a standardized approach to after visit instructions which included a customizable template that would review patients conditions, changes in any medications, and any future labs, imaging, or referrals.</description>
      <arm_group_label>Standardized After Visit Instructions Only</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standardized After Visit Instructions &amp; Teach Back</intervention_name>
      <description>This intervention included the Standardized After Visit Instructions and included teach back, a process by which patients restate in their own words their understanding of their condition, what was discussed in the visit, and what potential changes were made</description>
      <arm_group_label>Standardized After Visit Instructions &amp; Teach Back</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients seen in the Rush University Medical Center Rheumatology Clinic&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tele-medicine visits&#xD;
  &#xD;
            -  English is not the primary language. This is due to inability of all providers to&#xD;
               provide custom AVI due to language limitations&#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>Sobia Hassan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Rush University Medical Center Associate Professor Rheumatology Department</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Rush University Medical Center Division of Rheumatology</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>After Visit Summary</keyword>
    <keyword>Readability</keyword>
    <keyword>REALM</keyword>
    <keyword>A-REALM</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>October 17, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT06021730/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>November 10, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT06021730/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06021730
  org study id: 22072004
  nct id: NCT06021730
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This prospective study aims to analyze the influence of standardized after visit instructions
        (AVI) and teach back (TB) method on patients' understanding of health information. The study
        divided routine clinic patients into three groups: standard care, standardized AVI, and
        standardized AVI with TB. Patient health literacy, satisfaction, and AVI comprehension were
        gauged through surveys and post-visit follow-up calls. The investigators hypothesized that
        there would be an improvement in patient comprehension with the standardized AVI or TB when
        compared to controls.
  This study seeks to investigate the discharge practices of the Rheumatology clinic and
        analyze whether variations in these practices impact patient satisfaction, enhance their
        comprehension of their disease, and potentially influence the progression of their condition.
        Participants agreeing to take part in this study will be engaged for a duration of up to
        three (3) weeks, encompassing two study visits-one during their regular clinic appointment
        and another through a telephone study visit.
  
        During the initial in-person visit, participants will complete a health literacy survey
        before their appointment and a satisfaction survey afterward. Approximately 1-2 weeks
        following the in-person visit, participants will receive a telephone call to respond to
        questions regarding their visit. More details of the study are outlined below.
  
        Prior to commencing the study, participants will be asked to provide their consent by signing
        a form indicating their willingness to take part. The participants will then be randomly
        allocated to one of three study groups: the Control Group, the After Visit Instructions (AVI)
        Group, or the AVI with teach back (TB) group.
  
        Throughout the course of the study, participants will engage in various activities. First,
        they will complete a health literacy form, designed to assess their familiarity with commonly
        used terms in rheumatology clinics. This will take place prior to the standard clinic visit
        and is expected to last around 5 minutes.
  
        During the regular clinic visit, participants will follow different protocols based on their
        assigned group:
  
          -  Participants in the Control Group will experience their usual clinic visit.
  
          -  Those in the AVI Group will receive a personalized set of After Visit Instructions (AVI)
             that detail any changes in their care. This additional interaction is anticipated to
             last approximately 2 minutes.
  
          -  Individuals in the AVI with TB Group will be asked to explain, in their own words, the
             modifications made during their visit. This interaction is expected to take an extra 1
             minute.
  
        After the clinic visit, all participants will complete a satisfaction survey, assessing both
        the provider's performance and their contentment with the discharge process. This survey is
        estimated to take around 3 minutes to complete.
  
        During the follow-up period, participants will receive a phone call 1-2 weeks after their
        clinic visit to respond to inquiries regarding their appointment experience and the discharge
        process. This telephone interview is anticipated to take around 10 minutes and aims to gather
        valuable insights.
  
        Furthermore, foundational data will be extracted from participants' electronic medical
        records. This information will encompass details such as gender, date of birth, ethnicity,
        race, specific disease information, ongoing medications, and data from forms filled out
        before each visit that provide a comprehensive view of disease activity.
  
        This study incorporates medical data from electronic medical records while ensuring
        confidentiality. Risks include potential loss of privacy, although safeguards are
        implemented. The study may extend the clinic visit by a maximum of 15 minutes, with no other
        anticipated risks.
  
        Potential benefits include enhanced discharge practices, including standardized AVI templates
        and the "teach back" method, which could improve disease comprehension and management
        adherence. However, responses to interventions can vary, so outcomes cannot be
        pre-determined.
  
        Participation in the control group offers no anticipated benefits. This study is not a
        treatment study, and the only alternative to participation is non-participation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Patient Comprehension Survey
  time frame: 1-2 weeks after initial visit
  description: This is a telephone survey that will assess patients comprehension of disease over three main categories: disease state, medication changes, and referral/imaging/lab requests. Each category will be measure concordance of the patients understanding with what was written in the note in the form of a percentage from 0% to 100%. A higher percentage means a better understanding of ones disease.
  measure: Patient Satisfaction Survey
  time frame: Will receive in email or in person immediately after initial visit
  description: Patient satisfaction will be assessed through a in person or email survey that will assess multiple elements of satisfaction. A higher score indicates a higher level of satisfaction.
  arm group label: Control
  arm group type: No Intervention
  description: Patients received standard after visit procedure based on the provider
  arm group label: Standardized After Visit Instructions Only
  arm group type: Experimental
  description: The standardized after visit instructions (AVI) only group included patients receiving typed standardized AVI which included a text template that providers used to write customized AVI for the patient.
  arm group label: Standardized After Visit Instructions & Teach Back
  arm group type: Active Comparator
  description: The standardized AVI & teach back (TB) group included standardized written AVI with the patient repeating to the provider which changes and future management had been agreed upon during the visit.
  intervention type: Behavioral
  intervention name: Standardized After Visit Instructions Only
  description: The intervention took a standardized approach to after visit instructions which included a customizable template that would review patients conditions, changes in any medications, and any future labs, imaging, or referrals.
  arm group label: Standardized After Visit Instructions Only
  intervention type: Behavioral
  intervention name: Standardized After Visit Instructions & Teach Back
  description: This intervention included the Standardized After Visit Instructions and included teach back, a process by which patients restate in their own words their understanding of their condition, what was discussed in the visit, and what potential changes were made
  arm group label: Standardized After Visit Instructions & Teach Back
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sobia Hassan, MD
  role: Principal Investigator
  affiliation: Rush University Medical Center Associate Professor Rheumatology Department
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No
  provided document: 
  provided document: 