跳至主要内容
临床试验/NCT07022769
NCT07022769进行中(未招募)不适用

Comparison of a Large Language Model (LLM)-Facilitated Cognitive Debiasing Strategy Versus LLM-Generated Diagnostic Feedback Alone in Musculoskeletal Specialty Care: A Randomized Controlled Trial

University of Texas at Austin1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年6月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
Trust and Experience with the Clinician Scale (TRECS-7)

研究概览

简要总结

The goal of this clinical trial is to find out whether using an artificial intelligence (AI) tool called a Large Language Model (LLM) can help patients think more clearly about their symptoms and improve their trust and experience during a visit to a musculoskeletal specialist.

The study will answer two main questions:

  1. Does an LLM-guided checklist that encourages patients to reflect on their beliefs about their symptoms improve their trust in the clinician (measured using the TRECS-7 scale)?
  2. Does the checklist improve how patients feel about their consultation overall?

Participants will be randomly assigned to one of two groups:

  • One group will receive an LLM-guided checklist that helps them think more flexibly about their condition.
  • The other group will receive an LLM-generated likely diagnosis and brief explanation of their symptoms.

In both groups, the information from the AI tool will be shared with both the patient and the clinician before the consultation.

Patients in the debiasing (intervention) group will:

  • Complete a short set of questions with help from a researcher
  • Receive a simple summary from the AI that reflects their beliefs and gently challenges any unhelpful thinking
  • Attend their regular specialist appointment
  • Complete a short survey afterwards capturing their thoughts, experience and basic demographics

Patients in the diagnosis-only (control) group will:

  • Describe their symptoms to the AI LLM
  • Receive a likely diagnosis and short explanation based on this description
  • Attend their regular specialist appointment
  • Complete a short survey afterwards capturing their thoughts, experience and basic demographics

详细描述

A patient's experience of physical discomfort and incapability is closely tied to how they interpret bodily sensations. The human mind is a meaning-making system that rapidly forms stories and assumptions about internal experiences. When individuals experience musculoskeletal pain or dysfunction, their initial interpretations often fall into broad cognitive categories: (1) harm that requires rest and protection; (2) threat to valued roles and activities; or (3) the belief that symptom elimination is the sole path to recovery. These automatic, unconscious interpretations can be adaptive in acute or dangerous situations, but they may also lead to biased or inaccurate symptom appraisals. When misaligned with the underlying pathology, such heuristics can exacerbate emotional distress, delay accurate diagnosis, and drive unnecessary investigations or treatments. The challenge, therefore, lies in supporting patients to reframe these beliefs and engage with their symptoms more adaptively.

Cognitive debiasing strategies have emerged as a promising approach to address this concern. These strategies aim to slow down automatic thinking, challenge entrenched assumptions, and promote more flexible, reflective, and value-aligned reasoning. By encouraging a more nuanced understanding of bodily signals, cognitive debiasing may improve the quality of clinical decisions and overall patient experience-offering advantages over traditional educational or informational tools.

Recent advances in Artificial Intelligence (AI), particularly the rise of Large Language Models (LLMs), have opened new possibilities for enhancing cognitive debiasing interventions. LLMs such as ChatGPT can analyze and synthesize patient-reported symptoms and beliefs to generate supportive, plain-language summaries of their thinking. This process may help patients recognize their own interpretive patterns and consider alternative, less distressing explanations for their symptoms. In parallel, LLMs can assist clinicians by flagging potentially unhelpful or distorted beliefs prior to a consultation, allowing for more tailored and empathic communication.

This trial tests whether a structured, LLM-facilitated debiasing intervention can better support accurate symptom appraisal and enhance the clinical encounter, compared to LLM-generated diagnosis alone. This work builds on the recognition that there is wide variation in musculoskeletal care experience and decision-making, with existing tools such as decision aids and question prompt lists often falling short in challenging rigid or unhelpful thinking patterns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (18+)
  • •New or return patient seeking musculoskeletal specialty care at an Orthopedic outpatient clinic
  • •Total combined score on the 6 feelings and thoughts items of > 10* (Appendix 3 of study protocol)
  • •English-speaking
  • •Pre-visit diagnosis of chronic, non-traumatic musculoskeletal condition (including, but not limited to: osteoarthritis, carpal tunnel syndrome, trigger digit, Dupuytren's, De Quervain's, lateral epicondylitis)

排除标准

  • •Any impairment preventing completion of surveys on a tablet

研究组 & 干预措施

LLM-Facilitated Cognitive Debiasing Aid

Experimental

The intervention is a four-part, tablet-based cognitive debiasing aid that uses a Large Language Model (LLM) to help patients reflect on and re-evaluate their beliefs about their symptoms prior to a musculoskeletal specialty care visit. Patient responses are summarized by the LLM in supportive language to promote flexible thinking, and a separate LLM-generated summary of potential unhelpful beliefs is shared with the clinician to guide empathic, individualized communication.

干预措施: LLM-facilitated cognitive debiasing aid (Behavioral)

Usual Care

No Intervention

In the control arm, patients use a tablet-based tool to describe their presenting musculoskeletal symptom, which is transcribed and input into a Large Language Model (LLM). The LLM generates a likely diagnosis with a brief neutral description, which is shared with both the patient and the clinician before the consultation. This approach offers diagnostic feedback without engaging in cognitive debiasing or reflection.

结局指标

主要结局

Trust and Experience with the Clinician Scale (TRECS-7)

时间窗: Measured once, immediately following consultation with the musculoskeletal specialist

The Trust and Experience with the Clinician Scale (TRECS-7) is a validated 7-item scale that measures patients' trust in and experience with their clinician during a medical consultation. Designed to minimize ceiling effects, it enables more sensitive detection of variation in patient experience across different clinical interactions (Brinkman et al.). Each of 7 statements is scored from 0-4 (strongly disagree, disagree, neutral, agree, strongly agree), resulting in a total score between 0 and 28. Higher scores indicate greater perceived trust in the clinician. Source: Brinkman N, Looman R, Jayakumar P, Ring D, Choi S. Is It Possible to Develop a Patient-reported Experience Measure With Lower Ceiling Effect? Clin Orthop Relat Res. 2025 Apr 1;483(4):693-703.

次要结局

  • Subjective Experience Using the LLM(Measured once, immediately following consultation with the musculoskeletal specialist)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Ring

Associate Dean for Comprehensive Care Professor and Associate Chair for Faculty Academic Affairs Department of Surgery and Perioperative Care, Courtesy Professor of Psychiatry and Behavioral Sciences

University of Texas at Austin

研究点 (1)

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