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/NCT06008418</url>
    </required_header>
    <id_info>
      <org_study_id>202303076RINB</org_study_id>
      <nct_id>NCT06008418</nct_id>
    </id_info>
    <brief_title>Using Mixed-methods Approach to Explore Health Communication in Hospice Out-Patient Settings</brief_title>
    <official_title>Using Mixed-methods Approach to Explore Health Communication in Hospice Out-Patient Settings (HOUSE): From Middle-range Theory to Clinical Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Science and Technology Council</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>National Taiwan University Hospital</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>
        This research project aims to investigate health communication in hospice outpatient settings&#xD;
        and translate findings into practice by designing and testing a communication aid utilizing&#xD;
        health information technology. The specific aims are to: (1) identify the attributes,&#xD;
        antecedents, consequences, and implications of the concept of illness invalidation; (2)&#xD;
        construct a theoretical framework to describe patient-healthcare provider communication; and&#xD;
        (3) based on the theoretical framework, establish a tailored communication aid using health&#xD;
        information technology; and investigate its effects on patient outcomes, including (a)&#xD;
        satisfaction, (b) communication self-efficacy, (c) illness invalidation, (d) shared-decision&#xD;
        making experience, (e) health-related quality of life, and (f) emergency room visits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While health communication is an established field with numerous publications over decades,&#xD;
        it is still hard to conceptualize health communication, including the antecedences and&#xD;
        consequences of real communication episodes. Before the mid-1900s, the concept of health&#xD;
        communication was more like a &quot;common sense&quot; or was pushed to the background as the focus of&#xD;
        medicine was on body systems or cell structure, rather than the whole person. Also, the&#xD;
        asymmetric nature of the patient-physician relationship contributes to the ignorance of the&#xD;
        quality of health communication. Along with the rise of the idea of &quot;marketing,&quot; health&#xD;
        communication became a distinct field when hospitals considered patients as consumers since&#xD;
        1960s. Health communication is defined as &quot;a multifaceted and multidisciplinary field of&#xD;
        research, theory, and practice concerned with reaching different populations and groups to&#xD;
        exchange health-related information…in order to influence, engage, empower, and support&#xD;
        individuals, communities, health care professions…&quot; By 1990s, the development and importance&#xD;
        of the field of health communication was established as the ideal of patient-centered care&#xD;
        has become the norm. The number of relevant research has grown since then and reached a peak&#xD;
        in 2018. Interestingly, the amount of published health communication studies has decreased&#xD;
        continuously after 2019, despite the constant focus on patient-centered, patient empowerment,&#xD;
        and shared-decision making. There is even fewer studies addressed populations with diverse&#xD;
        culture background or frontline health communication scenarios. The lack of updated evidence&#xD;
        in the field contributes to the fragmental knowledge, including not reflecting the impacts of&#xD;
        social and technology changes on health communication and theories that can be easily applied&#xD;
        to clinical practice.&#xD;
  &#xD;
        The lack of interpersonal communication theories considering real-life medical encounters. As&#xD;
        described in the definition of health communication, health communication is a&#xD;
        multidisciplinary field which can be observed from its complicated theory background.&#xD;
        Theories related to interpersonal health communication were often borrowed from behavioral&#xD;
        and social science, medical models, or interpersonal communication filed. These theories can&#xD;
        be roughly categorized in to two groups: theories that are more related to interpersonal or&#xD;
        mass communication. The two groups were distinguished based on accessibility and message&#xD;
        personalization. Because this research project focus on patient-provider communication, the&#xD;
        following paragraphs mainly discuss evidence related to interpersonal communication which&#xD;
        limits accessibility to a smaller group of people and enable more personalized message.&#xD;
  &#xD;
        Except for some theories developed in the interpersonal communication field, most theories&#xD;
        that were used to guide health communication research does not address communication&#xD;
        directly. For example, health believe model, a theory established in behavioral and social&#xD;
        science, has been frequently used to observe the impacts of health communication.&#xD;
        Nevertheless, none of the key concepts of health believe model was directly linked to&#xD;
        communication. Although communication certainly plays important roles in health beliefs, it&#xD;
        is difficult to evaluate or improve real patient-provider communication based on health&#xD;
        believe model. Although theories developed by interpersonal communication scholars do address&#xD;
        communication goals, process, or outcomes directly, there is still a gap between theory and&#xD;
        practice. For example, the majority of these interpersonal communication theories were tested&#xD;
        in non-medical encounters. Medical encounters differ than other types of encounters in its&#xD;
        therapeutic relationship, unequal power, and special goals and environment. It is hard to&#xD;
        apply findings derived from other types of encounters to medical encounters. The remaining&#xD;
        few interpersonal theories that specifically address medical encounters, such as uncertainty&#xD;
        management theories, action-implicative discourse analysis theory, and multiple goals theory,&#xD;
        are probably the most appropriate framework to guide practice and research relevant to real&#xD;
        patient-provider communication. However, these theories either only look at special, single&#xD;
        concept (e.g., uncertainty in uncertainty management theories, goals in multiple goals&#xD;
        theory) or belong to grand theory without describing specific relationships between concepts.&#xD;
        There is a scant of literature or framework describe patient-provider communication as a&#xD;
        whole, including special concepts and their relationships.&#xD;
  &#xD;
        Challenges to patient-provider communication are changing and continue to exist. In the early&#xD;
        21st century, one of the major communication problems between provider and patient is related&#xD;
        to physician dominance and physician-centered. While the concept of patient-centered care has&#xD;
        been advocated, recent research still indicate that physicians failed to elicit patients'&#xD;
        agenda in over half of the medical encounters. Similar to international scholars' findings,&#xD;
        previous study also showed questionable communication quality in Taiwan's outpatient&#xD;
        settings. Specifically, while patients and caregivers had high level of agreement regarding&#xD;
        symptom evaluation, the agreement of symptom evaluation between patients and healthcare&#xD;
        providers was not optimal. These challenges support the needs to continuously and intensely&#xD;
        examine patient-provider communication theory and practice.&#xD;
  &#xD;
        The overall aim of this research project is to investigate health communication in hospice&#xD;
        outpatient settings and translate findings into practice by designing and testing a&#xD;
        communication aid utilizing health information technology. The specific aims are to: (1)&#xD;
        identify the attributes, antecedents, consequences, and implication of the concept of illness&#xD;
        invalidation; (2) construct a theoretical framework to describe patient-healthcare provider&#xD;
        communication; and (3) based on the theoretical framework, establish a tailored communication&#xD;
        aid using health information technology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Once the patients agree to participate and provide written consent, participants will be assigned to a comparison group or treatment group according to the time of their outpatient appointment. Specifically, during the nine-month period of recruitment, the comparison group participants will be recruited during the first half of the period; and the experimental group will be recruited in the next half of the period. The reason of assigning participants according to time rather than randomization is because of the possible contamination. Because the intervention is designed to be interactive, the intervention will affect not only participating patients' communication behavior but also the physician's behavior.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Communication self-efficacy(before)</measure>
      <time_frame>immediately before outpatient visit (T0)</time_frame>
      <description>Before the outpatient visit, communication self-efficacy will be measured by Perceived Efficacy in Patient-Physician Interactions Scales (Chinese version). Knowing the patients' baseline of self-efficacy in &quot;obtaining medical information and attention to their medical concerns from physicians&quot;. Ranging from 0 to 10, patients rate from no confidence to extremely confidence to interact with healthcare providers. The total score range between 0 and 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Symptoms and quality of life(before)</measure>
      <time_frame>immediately before outpatient visit (T0)</time_frame>
      <description>Before the outpatient visit, health-related quality of life will be measured by European Organization for Research and Treatment of Cancer (Taiwan Chinese version). Knowing the patients' baseline of functions, symptoms, and overall quality of life. Patients' function and symptom sub-scales are measured by a 4-point Likert scales while overall quality of life sub-scale is measured by a 7-point Likert scales. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Subjects satisfaction</measure>
      <time_frame>24 hours after the outpatient visit (T1)</time_frame>
      <description>After 24 hours of the outpatient visit and using the LINE chatbot device, satisfaction will be measured by the Chinese Patients' Satisfaction Scale.&#xD;
  It contains eight aspects (i.e., professionalism, hospitality, patience, efficiency, respect, responsibility, fairness, and ethics) of patients' satisfaction by using a 5-point Likert scale (a higher score means more satisfaction).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Communication self-efficacy(after)</measure>
      <time_frame>24 hours after the outpatient visit (T1)</time_frame>
      <description>After 24 hours of the outpatient visit and using the LINE chatbot device, communication self-efficacy will be measured by Perceived Efficacy in Patient-Physician Interactions Scales (Chinese version). Change from the patients' baseline of self-efficacy in &quot;obtaining medical information and attention to their medical concerns from physicians&quot;. Ranging from 0 to 10, patients rate from no confidence to extremely confidence to interact with healthcare providers. The total score range between 0 and 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Decision making process</measure>
      <time_frame>24 hours after the outpatient visit (T1)</time_frame>
      <description>After 24 hours of the outpatient visit and using the LINE chatbot device, the quality of shared-decision making will be measured by the 9-item Shared Decision-Making Questionnaire. Shared-decision making uses a 6-point Likert scale (from completely disagree to completely agree). The total raw score is between 0 and 45 and will be transformed to range from 0 to 100 by multiplying the raw score by 20/9.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Invalidation experience</measure>
      <time_frame>24 hours after the outpatient visit (T1)</time_frame>
      <description>After 24 hours of the outpatient visit and using the LINE chatbot device, invalidation experience will be assessed by the Illness Invalidation Inventory. The outcome of patients' perceptions of discounting and lack of understanding will use a 5-point Likert scale questionnaire. Total score range between 8 and 40 with a higher score representing a higher level of invalidation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Symptoms and quality of life(after)</measure>
      <time_frame>A week after the outpatient visit (T2)</time_frame>
      <description>After a week of outpatient visit, health-related quality of life as assessed by European Organization for Research and Treatment of Cancer (Taiwan Chinese version). Change from the baseline of patients' functions, symptoms, and overall quality of life. Patients' function and symptom sub-scales are measured by a 4-point Likert scales while overall quality of life sub-scale is measured by a 7-point Likert scales. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Provider-patient communication dynamic experience</measure>
      <time_frame>within 1 year</time_frame>
      <description>A grounded theory approach will be used to construct a theoretical framework for provider-patient communication. The process is fundamental to human experience and advocates developing theories grounded in data. The aim focuses on exploring provider-patient communication, which is a dynamic process.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">184</enrollment>
    <condition>Communication</condition>
    <condition>Palliative Care</condition>
    <arm_group>
      <arm_group_label>The LINE Chatbot</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants of the experimental group are required to use the Chatbot before discussing with their physicians.&#xD;
  Outcome variables are mainly measured at three points: baseline (immediately before the outpatient visit), 24 hours within the outpatient visit, and a week after. At baseline, participants provide their demographic information and complete questionnaires to evaluate their communication self-efficacy and quality of life. After 24 hours, participants are invited to evaluate their satisfaction, communication self-efficacy, shared-decision making process, and the experience of illness invalidation. After a week, the research assistant will remind the participant to evaluate their quality of life. Finally, a retrospective chart review will be conducted one month after the visit to confirm any emergency department visits. Except for the demographic variables (i.e., age, sex, educational level, and diagnosis) and emergency visits.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Routine</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The comparison group participants will receive routine care (i.e., oral instruction regarding the overall process of outpatient department visits).&#xD;
  Outcome variables are mainly measured at three points: baseline (immediately before the outpatient visit), 24 hours within the outpatient visit, and a week after. At baseline, participants provide their demographic information and complete questionnaires to evaluate their communication self-efficacy and quality of life. After 24 hours, participants are invited to evaluate their satisfaction, communication self-efficacy, shared-decision making process, and the experience of illness invalidation. After a week, the research assistant will remind the participant to evaluate their quality of life. Finally, a retrospective chart review will be conducted one month after the visit to confirm any emergency department visits. Except for the demographic variables (i.e., age, sex, educational level, and diagnosis) and emergency visits.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The LINE Chatbot</intervention_name>
      <description>The chatbot approach is selected as it uses artificial intelligence to simulate conversations with users. The information can be collected or distributed and even through these conversations trigger human actions. LINE is one of the most widely used freeware applications in Taiwan and its chatbot function is well-organized and relatively easy to modify, adapt, and use. The design of the chatbot aims at the two elements above, ensuring goal alignment and enhancing power sharing, by guiding participants to complete three activities: specifying their goals for today's discussions, providing patient-reported outcomes by self-rating their health-related quality of life, and learning question prompt list based on their needs.</description>
      <arm_group_label>The LINE Chatbot</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. terminally ill with a life expectancy of 6 months or less&#xD;
  &#xD;
            2. 18-year-old or older&#xD;
  &#xD;
            3. able to communicate using Mandarin or Taiwanese&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who are not able to use electronic devices due to physical, psychological, or&#xD;
               cognitive issues will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>National Taiwan University Hospital</last_name>
      <role>Study Chair</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>10051</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06008418
  org study id: 202303076RINB
  nct id: NCT06008418
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This research project aims to investigate health communication in hospice outpatient settings
        and translate findings into practice by designing and testing a communication aid utilizing
        health information technology. The specific aims are to: (1) identify the attributes,
        antecedents, consequences, and implications of the concept of illness invalidation; (2)
        construct a theoretical framework to describe patient-healthcare provider communication; and
        (3) based on the theoretical framework, establish a tailored communication aid using health
        information technology; and investigate its effects on patient outcomes, including (a)
        satisfaction, (b) communication self-efficacy, (c) illness invalidation, (d) shared-decision
        making experience, (e) health-related quality of life, and (f) emergency room visits.
  While health communication is an established field with numerous publications over decades,
        it is still hard to conceptualize health communication, including the antecedences and
        consequences of real communication episodes. Before the mid-1900s, the concept of health
        communication was more like a "common sense" or was pushed to the background as the focus of
        medicine was on body systems or cell structure, rather than the whole person. Also, the
        asymmetric nature of the patient-physician relationship contributes to the ignorance of the
        quality of health communication. Along with the rise of the idea of "marketing," health
        communication became a distinct field when hospitals considered patients as consumers since
        1960s. Health communication is defined as "a multifaceted and multidisciplinary field of
        research, theory, and practice concerned with reaching different populations and groups to
        exchange health-related information…in order to influence, engage, empower, and support
        individuals, communities, health care professions…" By 1990s, the development and importance
        of the field of health communication was established as the ideal of patient-centered care
        has become the norm. The number of relevant research has grown since then and reached a peak
        in 2018. Interestingly, the amount of published health communication studies has decreased
        continuously after 2019, despite the constant focus on patient-centered, patient empowerment,
        and shared-decision making. There is even fewer studies addressed populations with diverse
        culture background or frontline health communication scenarios. The lack of updated evidence
        in the field contributes to the fragmental knowledge, including not reflecting the impacts of
        social and technology changes on health communication and theories that can be easily applied
        to clinical practice.
  
        The lack of interpersonal communication theories considering real-life medical encounters. As
        described in the definition of health communication, health communication is a
        multidisciplinary field which can be observed from its complicated theory background.
        Theories related to interpersonal health communication were often borrowed from behavioral
        and social science, medical models, or interpersonal communication filed. These theories can
        be roughly categorized in to two groups: theories that are more related to interpersonal or
        mass communication. The two groups were distinguished based on accessibility and message
        personalization. Because this research project focus on patient-provider communication, the
        following paragraphs mainly discuss evidence related to interpersonal communication which
        limits accessibility to a smaller group of people and enable more personalized message.
  
        Except for some theories developed in the interpersonal communication field, most theories
        that were used to guide health communication research does not address communication
        directly. For example, health believe model, a theory established in behavioral and social
        science, has been frequently used to observe the impacts of health communication.
        Nevertheless, none of the key concepts of health believe model was directly linked to
        communication. Although communication certainly plays important roles in health beliefs, it
        is difficult to evaluate or improve real patient-provider communication based on health
        believe model. Although theories developed by interpersonal communication scholars do address
        communication goals, process, or outcomes directly, there is still a gap between theory and
        practice. For example, the majority of these interpersonal communication theories were tested
        in non-medical encounters. Medical encounters differ than other types of encounters in its
        therapeutic relationship, unequal power, and special goals and environment. It is hard to
        apply findings derived from other types of encounters to medical encounters. The remaining
        few interpersonal theories that specifically address medical encounters, such as uncertainty
        management theories, action-implicative discourse analysis theory, and multiple goals theory,
        are probably the most appropriate framework to guide practice and research relevant to real
        patient-provider communication. However, these theories either only look at special, single
        concept (e.g., uncertainty in uncertainty management theories, goals in multiple goals
        theory) or belong to grand theory without describing specific relationships between concepts.
        There is a scant of literature or framework describe patient-provider communication as a
        whole, including special concepts and their relationships.
  
        Challenges to patient-provider communication are changing and continue to exist. In the early
        21st century, one of the major communication problems between provider and patient is related
        to physician dominance and physician-centered. While the concept of patient-centered care has
        been advocated, recent research still indicate that physicians failed to elicit patients'
        agenda in over half of the medical encounters. Similar to international scholars' findings,
        previous study also showed questionable communication quality in Taiwan's outpatient
        settings. Specifically, while patients and caregivers had high level of agreement regarding
        symptom evaluation, the agreement of symptom evaluation between patients and healthcare
        providers was not optimal. These challenges support the needs to continuously and intensely
        examine patient-provider communication theory and practice.
  
        The overall aim of this research project is to investigate health communication in hospice
        outpatient settings and translate findings into practice by designing and testing a
        communication aid utilizing health information technology. The specific aims are to: (1)
        identify the attributes, antecedents, consequences, and implication of the concept of illness
        invalidation; (2) construct a theoretical framework to describe patient-healthcare provider
        communication; and (3) based on the theoretical framework, establish a tailored communication
        aid using health information technology.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Once the patients agree to participate and provide written consent, participants will be assigned to a comparison group or treatment group according to the time of their outpatient appointment. Specifically, during the nine-month period of recruitment, the comparison group participants will be recruited during the first half of the period; and the experimental group will be recruited in the next half of the period. The reason of assigning participants according to time rather than randomization is because of the possible contamination. Because the intervention is designed to be interactive, the intervention will affect not only participating patients' communication behavior but also the physician's behavior.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Communication self-efficacy(before)
  time frame: immediately before outpatient visit (T0)
  description: Before the outpatient visit, communication self-efficacy will be measured by Perceived Efficacy in Patient-Physician Interactions Scales (Chinese version). Knowing the patients' baseline of self-efficacy in "obtaining medical information and attention to their medical concerns from physicians". Ranging from 0 to 10, patients rate from no confidence to extremely confidence to interact with healthcare providers. The total score range between 0 and 100.
  measure: Symptoms and quality of life(before)
  time frame: immediately before outpatient visit (T0)
  description: Before the outpatient visit, health-related quality of life will be measured by European Organization for Research and Treatment of Cancer (Taiwan Chinese version). Knowing the patients' baseline of functions, symptoms, and overall quality of life. Patients' function and symptom sub-scales are measured by a 4-point Likert scales while overall quality of life sub-scale is measured by a 7-point Likert scales. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.
  measure: Subjects satisfaction
  time frame: 24 hours after the outpatient visit (T1)
  description: After 24 hours of the outpatient visit and using the LINE chatbot device, satisfaction will be measured by the Chinese Patients' Satisfaction Scale.
  It contains eight aspects (i.e., professionalism, hospitality, patience, efficiency, respect, responsibility, fairness, and ethics) of patients' satisfaction by using a 5-point Likert scale (a higher score means more satisfaction).
  measure: Communication self-efficacy(after)
  time frame: 24 hours after the outpatient visit (T1)
  description: After 24 hours of the outpatient visit and using the LINE chatbot device, communication self-efficacy will be measured by Perceived Efficacy in Patient-Physician Interactions Scales (Chinese version). Change from the patients' baseline of self-efficacy in "obtaining medical information and attention to their medical concerns from physicians". Ranging from 0 to 10, patients rate from no confidence to extremely confidence to interact with healthcare providers. The total score range between 0 and 100.
  measure: Decision making process
  time frame: 24 hours after the outpatient visit (T1)
  description: After 24 hours of the outpatient visit and using the LINE chatbot device, the quality of shared-decision making will be measured by the 9-item Shared Decision-Making Questionnaire. Shared-decision making uses a 6-point Likert scale (from completely disagree to completely agree). The total raw score is between 0 and 45 and will be transformed to range from 0 to 100 by multiplying the raw score by 20/9.
  measure: Invalidation experience
  time frame: 24 hours after the outpatient visit (T1)
  description: After 24 hours of the outpatient visit and using the LINE chatbot device, invalidation experience will be assessed by the Illness Invalidation Inventory. The outcome of patients' perceptions of discounting and lack of understanding will use a 5-point Likert scale questionnaire. Total score range between 8 and 40 with a higher score representing a higher level of invalidation.
  measure: Symptoms and quality of life(after)
  time frame: A week after the outpatient visit (T2)
  description: After a week of outpatient visit, health-related quality of life as assessed by European Organization for Research and Treatment of Cancer (Taiwan Chinese version). Change from the baseline of patients' functions, symptoms, and overall quality of life. Patients' function and symptom sub-scales are measured by a 4-point Likert scales while overall quality of life sub-scale is measured by a 7-point Likert scales. Higher scores for symptom scales represent more intense symptoms while higher scores for function scales and quality of life mean better function and quality level.
  measure: Provider-patient communication dynamic experience
  time frame: within 1 year
  description: A grounded theory approach will be used to construct a theoretical framework for provider-patient communication. The process is fundamental to human experience and advocates developing theories grounded in data. The aim focuses on exploring provider-patient communication, which is a dynamic process.
  arm group label: The LINE Chatbot
  arm group type: Experimental
  description: Participants of the experimental group are required to use the Chatbot before discussing with their physicians.
  Outcome variables are mainly measured at three points: baseline (immediately before the outpatient visit), 24 hours within the outpatient visit, and a week after. At baseline, participants provide their demographic information and complete questionnaires to evaluate their communication self-efficacy and quality of life. After 24 hours, participants are invited to evaluate their satisfaction, communication self-efficacy, shared-decision making process, and the experience of illness invalidation. After a week, the research assistant will remind the participant to evaluate their quality of life. Finally, a retrospective chart review will be conducted one month after the visit to confirm any emergency department visits. Except for the demographic variables (i.e., age, sex, educational level, and diagnosis) and emergency visits.
  arm group label: Routine
  arm group type: No Intervention
  description: The comparison group participants will receive routine care (i.e., oral instruction regarding the overall process of outpatient department visits).
  Outcome variables are mainly measured at three points: baseline (immediately before the outpatient visit), 24 hours within the outpatient visit, and a week after. At baseline, participants provide their demographic information and complete questionnaires to evaluate their communication self-efficacy and quality of life. After 24 hours, participants are invited to evaluate their satisfaction, communication self-efficacy, shared-decision making process, and the experience of illness invalidation. After a week, the research assistant will remind the participant to evaluate their quality of life. Finally, a retrospective chart review will be conducted one month after the visit to confirm any emergency department visits. Except for the demographic variables (i.e., age, sex, educational level, and diagnosis) and emergency visits.
  intervention type: Behavioral
  intervention name: The LINE Chatbot
  description: The chatbot approach is selected as it uses artificial intelligence to simulate conversations with users. The information can be collected or distributed and even through these conversations trigger human actions. LINE is one of the most widely used freeware applications in Taiwan and its chatbot function is well-organized and relatively easy to modify, adapt, and use. The design of the chatbot aims at the two elements above, ensuring goal alignment and enhancing power sharing, by guiding participants to complete three activities: specifying their goals for today's discussions, providing patient-reported outcomes by self-rating their health-related quality of life, and learning question prompt list based on their needs.
  arm group label: The LINE Chatbot
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: National Taiwan University Hospital
  role: Study Chair
  affiliation: National Taiwan University Hospital
  facility: 
  country: Taiwan
  responsible party type: Sponsor