<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/NCT01685541</url>
  </required_header>
  <id_info>
    <org_study_id>HHSA29010007</org_study_id>
    <nct_id>NCT01685541</nct_id>
  </id_info>
  <brief_title>Evaluation of Computer Generated After Visit Summaries</brief_title>
  <official_title>Evaluation of Computer Generated After Visit Summaries to Support Patient-Centered Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The electronic medical record (EMR) offers a new method to provide patients with information&#xD;
      about their visits with a clinician. The EMR can generate personalized and patient specific&#xD;
      handouts at the end of the visit that can recap the topics covered during that visit. These&#xD;
      After Visit Summaries (AVS) can be automatically generated with information contained in the&#xD;
      patient's chart. The AVS has the potential to improve patient retention of information needed&#xD;
      for adherence to treatment plans, and follow-up instructions, and to facilitate information&#xD;
      transfer between healthcare settings. However, the content and formatting of the AVS to&#xD;
      optimize patients' information retention and satisfaction with the visit is not known. In&#xD;
      this study, we will develop and test in a randomized trial three different versions of an AVS&#xD;
      to determine the AVS content that maximizes patient satisfaction and retention of information&#xD;
      on the AVS,and adherence to physician instructions. The three versions of the AVS developed&#xD;
      from patient and physician input will be compared to a control condition which consists of&#xD;
      current practice in each setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will conduct an experiment in the four selected primary care clinics to test objectively&#xD;
      the effect of three levels of AVS content on patient recall of personal visit information,&#xD;
      satisfaction with the information received from their providers, and uses of the information&#xD;
      after their visits.&#xD;
&#xD;
      The four clinics were selected to provide a diverse patient sample with regard to&#xD;
      socioeconomic status, race/ethnicity and language preference. The study is planned to have a&#xD;
      total of 68 patients in each AVS form group (272 total), and 136 patients in each language&#xD;
      group. In our previous research in these SPUR-Net clinics, we found that it is very difficult&#xD;
      to recruit Spanish-language preference individuals in private practice settings. The great&#xD;
      majority of persons of Hispanic ethnicity who attend private practice clinics prefer to&#xD;
      communicate in English. For this reason, we will not attempt to recruit Spanish-speakers from&#xD;
      the Baylor Family Medicine Clinic. Patients will be approached, and if they agree to&#xD;
      participate they will be consented for the study. At the end of the visit, each study patient&#xD;
      will be randomized either to the control group or one of the three experimental groups. The&#xD;
      RA will accomplish this by opening a sealed envelope that contains the randomly generated&#xD;
      group assignment. For the experimental AVS's, the RA will select and generate the appropriate&#xD;
      study AVS in Epic. For the control group, the AVS that is currently being used in that clinic&#xD;
      will be printed and distributed to the patient. All research subjects will then be contacted&#xD;
      in 24 hours, and then again in 2-3 weeks to study the following outcomes.&#xD;
&#xD;
      We are not able to test a control condition that withholds an AVS altogether, in as much as&#xD;
      JACHO standards governing some of the participating clinics require an AVS of some kind.&#xD;
&#xD;
      Primary Outcome: The primary outcome measure will be the amount of information recalled by&#xD;
      patients at two time points: 2 days after the primary care visit, and 2-3 weeks after the&#xD;
      visit. The recall test will consist of two parts. Part 1 will involve recall of the general&#xD;
      categories of information contained on the AVS. Sample questions are:&#xD;
&#xD;
        -  Did the form have information about your blood pressure?&#xD;
&#xD;
        -  Did the form have information about your medications?&#xD;
&#xD;
        -  Did the form have a list of your health problems?&#xD;
&#xD;
      The responses will be scored as correct or incorrect, depending on the version of the AVS&#xD;
      randomly assigned to the patient. The final version of the recall test will be developed&#xD;
      after the focus group analysis, when a final determination of the content of the three forms&#xD;
      of the AVS is completed.&#xD;
&#xD;
      Part 2 of the recall test will ask the patient to generate the list of medications prescribed&#xD;
      and instructions given. This represents the content of the minimum information AVS (Form 3),&#xD;
      which can be answered by all study participants. The patients' answers will be recorded in&#xD;
      the data base verbatim, and at the completion of data collection, the investigators will&#xD;
      develop scoring rules to assign a score to each item. These rules will account for informal&#xD;
      names for medications (such as &quot;water pill,&quot; &quot;sugar pill,&quot; etc.). The score on this part will&#xD;
      be the percent of medication information correctly recalled, including name of pill (formal&#xD;
      or informal), number of doses to be taken per day, and timing of dose. The total test score&#xD;
      will be the percent of items correctly recalled. The two parts can be analyzed separately and&#xD;
      as a total score.&#xD;
&#xD;
      Secondary Outcomes&#xD;
&#xD;
      Patient Satisfaction with the AVS will be assessed with a 9-item questionnaire adapted from a&#xD;
      longer patient satisfaction scale developed by researchers in Baylor's Department of Family&#xD;
      and Community Medicine for evaluating patient responses to educational materials. Response&#xD;
      options to a series of questions regarding satisfaction with various characteristics of the&#xD;
      AVS range from &quot;strongly agree&quot; to &quot;strongly disagree.&quot; Two open ended questions will provide&#xD;
      patients the opportunity to mention elements of the AVS, or their reaction to it, that might&#xD;
      not have been anticipated by the research team. The form will be available in both English&#xD;
      and Spanish versions.&#xD;
&#xD;
      Adherence to Treatment will be assessed to examine whether the different AVS formats&#xD;
      influence patients' self-reported adherence to the provider's recommendations. We will use a&#xD;
      general measure of adherence that summarizes information about the patient's tendency to&#xD;
      adhere to medical recommendations, regardless of type of treatment recommended. The items in&#xD;
      this measure are:&#xD;
&#xD;
        1. I had a hard time doing what the doctor suggested I do;&#xD;
&#xD;
        2. I found it easy to do the things my doctor suggested I do;&#xD;
&#xD;
        3. I was unable to do what was necessary to follow my doctor's treatment plans;&#xD;
&#xD;
        4. I followed my doctor's suggestions exactly; and&#xD;
&#xD;
        5. Generally speaking, how often during the past 4 weeks were you able to do what the&#xD;
           doctor told you?&#xD;
&#xD;
      Response options for each item range from &quot;none of the time&quot; to &quot;all of the time.&quot; The&#xD;
      general adherence scale was constructed by averaging responses to the five items and&#xD;
      transforming the result linearly to a 0-100 distribution. This scale, developed in&#xD;
      conjunction with the Health Outcomes Study, has demonstrated good internal reliability&#xD;
      approaching .80, and acceptable stability over time. Standard back translation procedures&#xD;
      have been used to construct an equivalent Spanish version.&#xD;
&#xD;
      Other Study Variables&#xD;
&#xD;
      Health Literacy will be assessed with the Short Test of Functional Health Literacy in Adults&#xD;
      (S-TOFHLA)in order to account for the effect of functional health literacy on response to the&#xD;
      AVS. Patients' health literacy skills are increasingly recognized as a critical variable in&#xD;
      primary care research. The S-TOFHLA is a timed reading comprehension test that measures&#xD;
      patients' ability to read and understand passages describing common medical instructions. It&#xD;
      is available in English and Spanish versions, takes approximately 7 minutes for patients to&#xD;
      complete, and is scored on a scale of 0 to 36. Patients are categorized as having adequate&#xD;
      health literacy if the S-TOFHLA score is 23-36, marginal health literacy if it is 17-22, and&#xD;
      inadequate health literacy if the score is 0-16.&#xD;
&#xD;
      Demographic and Health variables will be collected, including such standard variables as age,&#xD;
      sex, race/ethnicity, and number of years of education completed. In order to adjust analyses&#xD;
      for disease severity, we will document the total number of health problems included in the&#xD;
      patient's problem list on the day of their study visit. In addition, because the salience of&#xD;
      the AVS may be related to the presence or absence of an acute condition, we will classify&#xD;
      each visit as to whether the problem list for the visit includes chronic conditions only, and&#xD;
      acute condition only, or a combination of acute and chronic problems. This categorical&#xD;
      variable will be included as a covariate in the outcomes analysis.&#xD;
&#xD;
      Analysis&#xD;
&#xD;
      If the potential confounders are evenly distributed across the study groups, the differences&#xD;
      among groups on the primary and secondary outcome measures will be tested by one-way ANOVA or&#xD;
      Chi-square analysis as appropriate for continuous or discrete variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <phase>Phase 3</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>Recall of After Visit Summary Content</measure>
    <time_frame>2 days post visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the After Visit Summary</measure>
    <time_frame>2 days post visit</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adherence to physician treatment recommendations</measure>
    <time_frame>2 days post visit and 2 weeks post visit</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">272</enrollment>
  <condition>Primary Care Patients With Chronic Conditions</condition>
  <arm_group>
    <arm_group_label>Maximum AVS Content</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AVS includes patient name, visit date, chief complaining, allergies, immunizations, vital signs, medications, problem list, lab order, physician contact information, referrals, instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate AVS content</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AVS includes patient name, visit date, vital signs, medications, diagnosis, problem list, physician contact information, referrals, instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Minimum AVS content</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AVS contains patient name, visit date, medications, diagnosis, physician contact information, referrals, instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (Usual AVS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Content differed by clinic site</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Maximum After Visit Summary Content</intervention_name>
    <arm_group_label>Maximum AVS Content</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intermediate After Visit Summary Content</intervention_name>
    <arm_group_label>Intermediate AVS content</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Minimum After Visit Summary Content</intervention_name>
    <arm_group_label>Minimum AVS content</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual AVS</intervention_name>
    <arm_group_label>Control Group (Usual AVS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Adult 21 or over&#xD;
&#xD;
          -  At least one previous visit to the clinic&#xD;
&#xD;
          -  Has one chronic condition require medications&#xD;
&#xD;
          -  Willing to participate and answer questionnaires by phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No previous visits to the clinic&#xD;
&#xD;
          -  Unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Valory Pavlik</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01685541
org study id: HHSA29010007
nct id: NCT01685541
lead sponsor: 
collaborator: 
has dmc: No
The electronic medical record (EMR) offers a new method to provide patients with information
      about their visits with a clinician. The EMR can generate personalized and patient specific
      handouts at the end of the visit that can recap the topics covered during that visit. These
      After Visit Summaries (AVS) can be automatically generated with information contained in the
      patient's chart. The AVS has the potential to improve patient retention of information needed
      for adherence to treatment plans, and follow-up instructions, and to facilitate information
      transfer between healthcare settings. However, the content and formatting of the AVS to
      optimize patients' information retention and satisfaction with the visit is not known. In
      this study, we will develop and test in a randomized trial three different versions of an AVS
      to determine the AVS content that maximizes patient satisfaction and retention of information
      on the AVS,and adherence to physician instructions. The three versions of the AVS developed
      from patient and physician input will be compared to a control condition which consists of
      current practice in each setting.
We will conduct an experiment in the four selected primary care clinics to test objectively
      the effect of three levels of AVS content on patient recall of personal visit information,
      satisfaction with the information received from their providers, and uses of the information
      after their visits.

      The four clinics were selected to provide a diverse patient sample with regard to
      socioeconomic status, race/ethnicity and language preference. The study is planned to have a
      total of 68 patients in each AVS form group (272 total), and 136 patients in each language
      group. In our previous research in these SPUR-Net clinics, we found that it is very difficult
      to recruit Spanish-language preference individuals in private practice settings. The great
      majority of persons of Hispanic ethnicity who attend private practice clinics prefer to
      communicate in English. For this reason, we will not attempt to recruit Spanish-speakers from
      the Baylor Family Medicine Clinic. Patients will be approached, and if they agree to
      participate they will be consented for the study. At the end of the visit, each study patient
      will be randomized either to the control group or one of the three experimental groups. The
      RA will accomplish this by opening a sealed envelope that contains the randomly generated
      group assignment. For the experimental AVS's, the RA will select and generate the appropriate
      study AVS in Epic. For the control group, the AVS that is currently being used in that clinic
      will be printed and distributed to the patient. All research subjects will then be contacted
      in 24 hours, and then again in 2-3 weeks to study the following outcomes.

      We are not able to test a control condition that withholds an AVS altogether, in as much as
      JACHO standards governing some of the participating clinics require an AVS of some kind.

      Primary Outcome: The primary outcome measure will be the amount of information recalled by
      patients at two time points: 2 days after the primary care visit, and 2-3 weeks after the
      visit. The recall test will consist of two parts. Part 1 will involve recall of the general
      categories of information contained on the AVS. Sample questions are:

        -  Did the form have information about your blood pressure?

        -  Did the form have information about your medications?

        -  Did the form have a list of your health problems?

      The responses will be scored as correct or incorrect, depending on the version of the AVS
      randomly assigned to the patient. The final version of the recall test will be developed
      after the focus group analysis, when a final determination of the content of the three forms
      of the AVS is completed.

      Part 2 of the recall test will ask the patient to generate the list of medications prescribed
      and instructions given. This represents the content of the minimum information AVS (Form 3),
      which can be answered by all study participants. The patients' answers will be recorded in
      the data base verbatim, and at the completion of data collection, the investigators will
      develop scoring rules to assign a score to each item. These rules will account for informal
      names for medications (such as "water pill," "sugar pill," etc.). The score on this part will
      be the percent of medication information correctly recalled, including name of pill (formal
      or informal), number of doses to be taken per day, and timing of dose. The total test score
      will be the percent of items correctly recalled. The two parts can be analyzed separately and
      as a total score.

      Secondary Outcomes

      Patient Satisfaction with the AVS will be assessed with a 9-item questionnaire adapted from a
      longer patient satisfaction scale developed by researchers in Baylor's Department of Family
      and Community Medicine for evaluating patient responses to educational materials. Response
      options to a series of questions regarding satisfaction with various characteristics of the
      AVS range from "strongly agree" to "strongly disagree." Two open ended questions will provide
      patients the opportunity to mention elements of the AVS, or their reaction to it, that might
      not have been anticipated by the research team. The form will be available in both English
      and Spanish versions.

      Adherence to Treatment will be assessed to examine whether the different AVS formats
      influence patients' self-reported adherence to the provider's recommendations. We will use a
      general measure of adherence that summarizes information about the patient's tendency to
      adhere to medical recommendations, regardless of type of treatment recommended. The items in
      this measure are:

        1. I had a hard time doing what the doctor suggested I do;

        2. I found it easy to do the things my doctor suggested I do;

        3. I was unable to do what was necessary to follow my doctor's treatment plans;

        4. I followed my doctor's suggestions exactly; and

        5. Generally speaking, how often during the past 4 weeks were you able to do what the
           doctor told you?

      Response options for each item range from "none of the time" to "all of the time." The
      general adherence scale was constructed by averaging responses to the five items and
      transforming the result linearly to a 0-100 distribution. This scale, developed in
      conjunction with the Health Outcomes Study, has demonstrated good internal reliability
      approaching .80, and acceptable stability over time. Standard back translation procedures
      have been used to construct an equivalent Spanish version.

      Other Study Variables

      Health Literacy will be assessed with the Short Test of Functional Health Literacy in Adults
      (S-TOFHLA)in order to account for the effect of functional health literacy on response to the
      AVS. Patients' health literacy skills are increasingly recognized as a critical variable in
      primary care research. The S-TOFHLA is a timed reading comprehension test that measures
      patients' ability to read and understand passages describing common medical instructions. It
      is available in English and Spanish versions, takes approximately 7 minutes for patients to
      complete, and is scored on a scale of 0 to 36. Patients are categorized as having adequate
      health literacy if the S-TOFHLA score is 23-36, marginal health literacy if it is 17-22, and
      inadequate health literacy if the score is 0-16.

      Demographic and Health variables will be collected, including such standard variables as age,
      sex, race/ethnicity, and number of years of education completed. In order to adjust analyses
      for disease severity, we will document the total number of health problems included in the
      patient's problem list on the day of their study visit. In addition, because the salience of
      the AVS may be related to the presence or absence of an acute condition, we will classify
      each visit as to whether the problem list for the visit includes chronic conditions only, and
      acute condition only, or a combination of acute and chronic problems. This categorical
      variable will be included as a covariate in the outcomes analysis.

      Analysis

      If the potential confounders are evenly distributed across the study groups, the differences
      among groups on the primary and secondary outcome measures will be tested by one-way ANOVA or
      Chi-square analysis as appropriate for continuous or discrete variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Recall of After Visit Summary Content
time frame: 2 days post visit
measure: Satisfaction with the After Visit Summary
time frame: 2 days post visit
measure: Adherence to physician treatment recommendations
time frame: 2 days post visit and 2 weeks post visit
arm group label: Maximum AVS Content
arm group type: Experimental
description: AVS includes patient name, visit date, chief complaining, allergies, immunizations, vital signs, medications, problem list, lab order, physician contact information, referrals, instructions
arm group label: Intermediate AVS content
arm group type: Experimental
description: AVS includes patient name, visit date, vital signs, medications, diagnosis, problem list, physician contact information, referrals, instructions
arm group label: Minimum AVS content
arm group type: Experimental
description: AVS contains patient name, visit date, medications, diagnosis, physician contact information, referrals, instructions
arm group label: Control Group (Usual AVS)
arm group type: Active Comparator
description: Content differed by clinic site
intervention type: Other
intervention name: Maximum After Visit Summary Content
arm group label: Maximum AVS Content
intervention type: Other
intervention name: Intermediate After Visit Summary Content
arm group label: Intermediate AVS content
intervention type: Other
intervention name: Minimum After Visit Summary Content
arm group label: Minimum AVS content
intervention type: Other
intervention name: Usual AVS
arm group label: Control Group (Usual AVS)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Valory Pavlik
investigator title: Associate Professor
mesh term: Chronic Disease