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CommunicationNCT06008418

Using Mixed-methods Approach to Explore Health Communication in Hospice Out-Patient Settings

A study testing The LINE Chatbot in people with Communication and Palliative Care, run by National Taiwan University Hospital at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Communication, Palliative Care
What is being tested?
The LINE Chatbot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteTaiwan
Study dates
1 Aug 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • terminally ill with a life expectancy of 6 months or less
  • 18-year-old or older
  • able to communicate using Mandarin or Taiwanese

Who cannot join

  • Patients who are not able to use electronic devices due to physical, psychological, or cognitive issues will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 10051

Other trials in Taiwan

About this study

Official title: Using Mixed-methods Approach to Explore Health Communication in Hospice Out-Patient Settings (HOUSE): From Middle-range Theory to Clinical Practice

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.

Read the detailed description

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.

Being tested
The LINE Chatbot
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The LINE ChatbotBehavioural

    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.

Study groups in NCT06008418
Study groupRoleWhat they receive
The LINE ChatbotExperimentalParticipants 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.
Receives: Behavioral: The LINE Chatbot
RoutineNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Communication self-efficacy(before)

    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.

    Measured: immediately before outpatient visit (T0)

  2. Symptoms and quality of life(before)

    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.

    Measured: immediately before outpatient visit (T0)

  3. Subjects satisfaction

    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).

    Measured: 24 hours after the outpatient visit (T1)

  4. Communication self-efficacy(after)

    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.

    Measured: 24 hours after the outpatient visit (T1)

  5. Decision making process

    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.

    Measured: 24 hours after the outpatient visit (T1)

  6. Invalidation experience

    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.

    Measured: 24 hours after the outpatient visit (T1)

  7. Symptoms and quality of life(after)

    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.

    Measured: A week after the outpatient visit (T2)

  8. Provider-patient communication dynamic experience

    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.

    Measured: within 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start1 Aug 2023
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008418
Sponsor's protocol ID
202303076RINB
Status last verified
Aug 2024
First submitted
30 Jul 2023
Last updated
20 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing The LINE Chatbot in people with Communication and Palliative Care, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Communication self-efficacy(before) (time frame: immediately before outpatient visit (T0)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.

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Clinical Trial NCT06008418 | AzTrials