Patient Aid for Theory-Driven Health Communication (PATH): Translating Goal-Power Theory Into an Instrument and Generative AI Support for Palliative Care Communication
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5)
研究概览
简要总结
The goal of this clinical trial is to learn whether an artificial intelligence (AI)-supported communication tool can help improve communication between people receiving palliative care and their healthcare providers. The study will also evaluate a new questionnaire designed to measure the quality of healthcare communication.
The main questions this study aims to answer are:
- Can the new questionnaire accurately measure the quality of communication between participants and healthcare providers?
- Does using the AI-supported communication tool, called NurseChat+, help participants feel more confident and prepared before meeting with their healthcare team?
- Does NurseChat+ improve the quality of communication during palliative care visits?
Researchers will compare participants who use NurseChat+ together with their usual care to participants who receive usual care alone to see whether the tool improves communication outcomes.
The study will be conducted in three stages. First, researchers will develop and test a questionnaire that measures healthcare communication. Next, they will develop and refine the NurseChat+ tool. Finally, they will test the tool in adults receiving palliative care at National Taiwan University Hospital.
Participants in the final stage of the study will be randomly assigned to one of two groups. One group will use NurseChat+ before their scheduled medical visits in addition to receiving usual care, while the other group will receive usual care only. Participants will complete questionnaires about their communication experiences during the study.
详细描述
Effective health communication is essential to patient well-being, yet the field is constrained by major theoretical and methodological gaps. Existing theories tend to address isolated communication phenomena and lack an integrative framework spanning the full continuum of patient-provider interaction. As a result, many measurement instruments lack a clear theoretical foundation and demonstrate inconsistent psychometric quality. In parallel, most AI-supported communication tools are technology-driven rather than theory-driven, and few have undergone rigorous clinical evaluation. Palliative care represents a high-stakes clinical context in which communication quality is central to outcomes, making it an ideal setting to test theory-based generative artificial intelligence (GenAI) communication interventions.
Grounded in the Goal-Power Theory of Communication developed by the applicant, this four-year project adopts a mixed-methods design to develop and evaluate a theory-based communication measurement instrument and a GenAI-supported communication aid, NurseChat+. The project comprises three sequential phases: (1) instrument development and validation, (2) intervention development and pilot testing, and (3) clinical evaluation using a randomized controlled trial (RCT). Phase 1 aims to develop and psychometrically validate a theory-based instrument for assessing health communication quality. Instrument development and validation will follow the MEASURE framework, including expert content validation and field testing with approximately 500 participants recruited from clinical settings within the National Taiwan University Hospital system. Phase 2 aims to develop and preliminarily validate the NurseChat+ using a user-centered design approach. A pilot usability and feasibility study will be conducted using a one-group pretest-posttest design with a minimum of 20 healthy adults to assess acceptability, usability, and preliminary effects on communication self-efficacy. Phase 3 will conduct a parallel-group, superiority RCT with an embedded mixed-methods design in palliative care outpatient and home care settings at National Taiwan University Hospital. Eligible adult patients receiving palliative care will be randomly allocated in a 1:1 ratio to the intervention group (NurseChat+ plus usual care) or the control group (usual care alone). The target sample size is 240 participants (120 per group). Intervention participants will use NurseChat+ prior to scheduled medical encounters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (Self-responding)
- •Inclusion Criteria:
- •Age 18 years or older.
- •Diagnosed with an advanced disease requiring consultation with outpatient palliative care clinics or home care services.
- •Able to self-complete the study questionnaires.
排除标准
- •Group 2: Caregivers (Proxy-responding) (Invited only when the patient meets the clinical criteria but is unable to self-complete the questionnaires)
- •Inclusion Criteria:
- •Age 18 years or older.
- •Identified as the primary family caregiver of a patient with an advanced disease requiring palliative care.
- •Exclusion Criteria:
- •Professional or paid caregivers.
- •Unable to complete the study questionnaires.
研究组 & 干预措施
NurseChat+ plus usual care
Participants in the experimental group will be invited to interact with NurseChat+ on an iPad provided by the research team before beginning their medical consultation. Successful completion of the intervention is defined as either a minimum of ten minutes of NurseChat+ use or completion of a full round of patient input, data retrieval, and response generation
干预措施: NurseChat+ (Behavioral)
Usual Care
Participants in the control group will receive usual palliative care without access to the NurseChat+ intervention. Usual care includes standard clinical consultations and communication with healthcare providers as provided in routine practice.
结局指标
主要结局
Change from Baseline in Communication Self-Efficacy via the 5-item Perceived Efficacy in Patient-Physician Interaction Scale (PEPPI-5)
时间窗: Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: immediately following the medical consultation or the interaction with GenAI communication aid).
【Randomized Control Trial \& Pilot study】The PEPPI-5 is a 5-item self-report instrument used to measure a patient's perceived self-efficacy in communicating with their physician. Each item is scored on a 5-point Likert scale from 1 (not at all confident) to 5 (very confident). The total score ranges from 5 to 25, with higher scores indicating higher levels of communication self-efficacy. Outcome will be assessed as the change in scores from T0 to T1.
Quality of Health Communication via the Phase-One Developed Instrument
时间窗: Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).
Evaluated using a newly developed and validated communication-quality instrument generated in Phase One of the study. This instrument is designed to comprehensively assess the specific communication quality, patterns, and clinical encounter effectiveness between healthcare providers and palliative care patients/families when aided by GenAI communication aid. The instrument is currently undergoing development and psychometric validation. The finalized total score will be structured such that higher scores will mathematically indicate a superior quality of health communication and better communication patterns.
次要结局
- System Usability Scale (SUS) Score of NurseChat+(Post-test (immediately after the interaction with GenAI communication aid).)
- Inventory of Technology Acceptance Model (ITAM) Score(Post-test ( immediately after the interaction with GenAI communication aid))
- Evaluation of User Experience via the User Experience Questionnaire (UEQ)(Post-test (immediately after the interaction with GenAI communication aid))
- Improvement in Symptom Burden via the Edmonton Symptom Assessment System (ESAS)(Baseline (T0: within 12 hours prior to the scheduled consultation) and Post-test (T1: post-consultation follow-up within 24-72 hours).)
- Patient Overall and Communication Satisfaction via the Chinese Patients' Satisfaction Scale (C-PSS)(Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).)
- Patient Satisfaction with Decision Making via the Satisfaction with Decision (SWD) Scale(Post-test follow-up (T1: 24-72 hours after the consultation via telephone interview).)