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Original Medical Notes Versus AI Plain-Language Summaries

2026年5月18日 更新者:David Ring、University of Texas at Austin

Patient Experience and Trust When Viewing Original Medical Notes Versus Large Language Model (LLM)-Generated Plain Language Summaries

The goal of this clinical trial is to learn how patients feel when reading their medical notes. The study compares reading the original doctor's note with reading a simpler, Artificial Intelligence (AI)-generated version written in plain language in adults receiving musculoskeletal specialty care.

The main questions the study aims to answer are:

  1. Does reading a plain-language summary change how patients feel about their doctor or their clinic experience?
  2. Does the type of note affect how comfortable, reassured, or worried patients feel?

Researchers will compare patients who read their original clinic note with patients who read an Artificial Intelligence (AI)-generated plain-language summary to see whether simpler language changes patient understanding, trust, or emotional responses.

Participants will:

  • Read either their original clinic note or a plain-language summary of the note
  • Complete short questionnaires about their experience, emotions, and trust in their clinician
  • Optionally provide written comments about how it felt to read the information

研究概览

详细说明

Background As patient access to electronic medical records becomes more widespread, understanding how individuals emotionally respond to their clinical documentation has become increasingly important. A qualitative study analyzing 600 medical encounter notes authored by 138 clinicians identified distinct patterns of language reflecting clinicians' attitudes toward patients. Five categories of negative language were described (questioning credibility, disapproval, stereotyping, labeling patients as "difficult," and unilateral decision-making), alongside six categories of positive language (compliments, approval, self-disclosure, minimizing blame, personalization, and collaborative decision-making). Prior research has demonstrated that access to clinical notes ('open notes') can influence patient experience, with potential benefits including improved understanding, greater trust, enhanced perceived quality of care, and increased engagement in self-care and health management. These benefits appear particularly pronounced with patients with lower education attainment or those from ethnic minority groups. Despite this, fewer than half of clinicians routinely discuss shared notes with patients during visits.

Rationale Language choices within clinical documentation may meaningfully shape how patients perceive their diagnosis, their relationship with healthcare providers, and their emotional well-being. For example, in a survey study of 100 healthy companions of orthopedic hand surgery patients, participants evaluated 19 commonly used medical terms and their synonyms using the Self-Assessment Manikin (SAM). Terms such as "pain" was rated more negatively than alternatives such as "discomfort" or "ache", while "rupture" elicited a more negative response than "tear" or "defect". These findings suggest that frequently used clinical terminology may also unintentionally elicit negative emotional reactions. Patients may be particularly vulnerable to language-related distress when reading their own medical records. The tone, complexity, and structure of these notes, especially in surgical specialties, may impact patient trust and overall comfort, and, in some cases, may unintentionally erode trust or intensify anxiety. Emerging evidence suggests that plain-language summaries might mitigate these effects. In a small study of 20 participants, artificial intelligence was used to generate plain-language medical notes, which were perceived as more useful, supportive of the patient-clinician relationship, and empowering for patients' understanding in their health. Although the importance and benefits of accessible visit notes have been well established, there remains limited empirical evidence regarding the optimal tone, structure, and language of medical documentation from the patient perspective.

Hypotheses

Primary hypothesis:

There are no factors associated with patient ratings of trust and experience with the clinician (TRECS), including whether patients viewed their original medical record entry or an LLM-generated plain language summary based on a curated version of the record (where PHI is removed) prior to the visit and other patient factors (demographics, mental health clusters).

Secondary hypotheses:

There are no factors associated with emotional responses to viewing one's own medical record entry, including whether patients view the original entry or an LLM-generated plain language summary based on a curated version of the record (where PHI is removed) prior to the visit and other patient factors (demographics, mental health clusters).

Qualitative hypothesis:

What themes does an LLM identify in patient verbatim comments regarding viewing their medical record entry or an LLM plain language summary?

研究类型

介入性

注册 (估计的)

135

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adult (18-89)
  • Seeking outpatient musculoskeletal specialty care
  • English language literacy
  • Return patient to the clinic

Exclusion criteria:

- Any impairment precluding completion of a survey on a tablet

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention (LLM-simplified notes)
Participants randomized to the intervention arm will review a plain-language summary generated from a curated version of their prior musculoskeletal clinic note using a large language model (LLM). All protected health information (PHI) and identifying information will be removed prior to LLM processing. The summary will be designed to simplify medical terminology and improve readability while maintaining the original clinical meaning of the note. The specific LLM used has not yet been finalized but will likely consist of the most current version of ChatGPT and/or Perplexity available through institutionally approved platforms at the time of the study. Participants will review the summary on an iPad prior to their clinic visit and complete questionnaires assessing trust, experience, and emotional responses.
The intervention consists of presenting participants with an LLM-generated plain-language summary of a prior musculoskeletal clinic note. The summary will be produced from a curated version of the original documentation after removal of all protected health information (PHI), macros, and administrative content. Physical therapy notes will be excluded, and normal examination or imaging findings may be simplified (e.g., "Exam otherwise normal"). The LLM will be instructed to preserve clinical meaning while reducing jargon and improving readability. The summary will be concise, neutral in tone, and written in patient-friendly language without adding new medical information or altering clinical recommendations. The specific LLM platform is not yet finalized but will likely use the most current version of ChatGPT and/or Perplexity available through institutional access.
有源比较器:Control (Original medical note)
Participants randomized to the control arm will review the original clinical note from their prior musculoskeletal clinic visit. The note will be presented in its original format without language simplification. Participants will review the note on an iPad prior to their clinic visit and complete questionnaires assessing trust, experience, and emotional responses.
Participants randomized to the control arm will review the original clinical note from their prior musculoskeletal clinic visit. The note will be presented in its original format without language simplification. Participants will review the note on an iPad prior to their clinic visit and complete questionnaires assessing trust, experience, and emotional responses.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Trust and Experience with the Clinician Scale (TRECS-7)
大体时间:Immediately after visit

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.

Time Frame: Measured once, immediately following consultation with the musculoskeletal specialist

Immediately after visit

次要结果测量

结果测量
措施说明
大体时间
Emotional response to medical note
大体时间:Immediately after intervention
Emotional responses to viewing one's own medical record will be assessed using 0-100 sliding scales measuring emotional comfort, anxiety, perceived clinician caring, and perceived impact on communication with the clinician. Higher or lower scores will reflect participants' position between paired emotional anchors including sad/happy, worried/at ease, doctor is caring/doctor is not caring, uncomfortable/comfortable, and affects communication/does not affect communication.
Immediately after intervention
Themes identified by the LLM in verbatim text
大体时间:Collected immediately after intervention/control
Themes identified from participant verbatim comments regarding their experience reading the study material. Participants will respond to the free-text prompt: "How did you feel reading your medical records before the visit with the clinician? (Please elaborate)" Responses will be analyzed using a large language model (LLM) to identify recurring themes related to understanding, emotional reactions, perceived trust, clarity of information, comfort or distress, and anticipated impact on communication with the clinician.
Collected immediately after intervention/control

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:David Ring, MD, PhD、Dell Medical School, University of Texas at Austin, TX, United States

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年2月1日

研究注册日期

首次提交

2026年5月9日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • STUDY00008863

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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