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

NCT06008418 | Enrolling By Invitation

• 1 other identifier: 202303076RINB
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Communication; Palliative Care

Outcome Measures

Primary Outcomes (8)

• 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.

  immediately before outpatient visit (T0)

• 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.

  immediately before outpatient visit (T0)

• 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).

  24 hours after the outpatient visit (T1)

• 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.

  24 hours after the outpatient visit (T1)

• 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.

  24 hours after the outpatient visit (T1)

• 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.

  24 hours after the outpatient visit (T1)

• 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.

  A week after the outpatient visit (T2)

• 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.

  within 1 year

Study Arms (2)

The LINE Chatbot

EXPERIMENTAL

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.

Behavioral: The LINE Chatbot

Routine

NO INTERVENTION

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.

Interventions

The LINE Chatbot BEHAVIORAL

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.

The LINE Chatbot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• National Taiwan University Hospital

  National Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 23, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 20, 2024

Record last verified: 2024-08

Locations

TW (1)