- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07602725
Original Medical Notes Versus AI Plain-Language Summaries
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:
- Does reading a plain-language summary change how patients feel about their doctor or their clinic experience?
- 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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?
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Emily H Jaarsma, MD
- Numer telefonu: 7472879601
- E-mail: emily.jaarsma@austin.utexas.edu
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Aktywny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Trust and Experience with the Clinician Scale (TRECS-7)
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Emotional response to medical note
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: David Ring, MD, PhD, Dell Medical School, University of Texas at Austin, TX, United States
Publikacje i pomocne linki
Publikacje ogólne
- Park J, Saha S, Chee B, Taylor J, Beach MC. Physician Use of Stigmatizing Language in Patient Medical Records. JAMA Netw Open. 2021 Jul 1;4(7):e2117052. doi: 10.1001/jamanetworkopen.2021.17052.
- Delbanco T, Walker J, Bell SK, Darer JD, Elmore JG, Farag N, Feldman HJ, Mejilla R, Ngo L, Ralston JD, Ross SE, Trivedi N, Vodicka E, Leveille SG. Inviting patients to read their doctors' notes: a quasi-experimental study and a look ahead. Ann Intern Med. 2012 Oct 2;157(7):461-70. doi: 10.7326/0003-4819-157-7-201210020-00002.
- Walker J, Leveille S, Bell S, Chimowitz H, Dong Z, Elmore JG, Fernandez L, Fossa A, Gerard M, Fitzgerald P, Harcourt K, Jackson S, Payne TH, Perez J, Shucard H, Stametz R, DesRoches C, Delbanco T. OpenNotes After 7 Years: Patient Experiences With Ongoing Access to Their Clinicians' Outpatient Visit Notes. J Med Internet Res. 2019 May 6;21(5):e13876. doi: 10.2196/13876.
- Gerard M, Chimowitz H, Fossa A, Bourgeois F, Fernandez L, Bell SK. The Importance of Visit Notes on Patient Portals for Engaging Less Educated or Nonwhite Patients: Survey Study. J Med Internet Res. 2018 May 24;20(5):e191. doi: 10.2196/jmir.9196.
- Bell SK, Mejilla R, Anselmo M, Darer JD, Elmore JG, Leveille S, Ngo L, Ralston JD, Delbanco T, Walker J. When doctors share visit notes with patients: a study of patient and doctor perceptions of documentation errors, safety opportunities and the patient-doctor relationship. BMJ Qual Saf. 2017 Apr;26(4):262-270. doi: 10.1136/bmjqs-2015-004697. Epub 2016 May 18.
- Vranceanu AM, Elbon M, Adams M, Ring D. The emotive impact of medical language. Hand (N Y). 2012 Sep;7(3):293-6. doi: 10.1007/s11552-012-9419-z.
- Bala S, Keniston A, Burden M. Patient Perception of Plain-Language Medical Notes Generated Using Artificial Intelligence Software: Pilot Mixed-Methods Study. JMIR Form Res. 2020 Jun 5;4(6):e16670. doi: 10.2196/16670.
- 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. doi: 10.1097/CORR.0000000000003262. Epub 2024 Oct 25.
- Santesso N, Rader T, Wells GA, O'Connor AM, Brooks PM, Driedger M, Gallois C, Kristjansson E, Lyddiatt A, O'Leary G, Prince M, Stacey D, Wale J, Welch V, Wilson AJ, Tugwell PS. Responsiveness of the Effective Consumer Scale (EC-17). J Rheumatol. 2009 Sep;36(9):2087-91. doi: 10.3899/jrheum.090363.
- Brinkman N, Broekman M, Teunis T, Choi S, Ring D, Jayakumar P. A New Measure of Quantified Social Health Is Associated With Levels of Discomfort, Capability, and Mental and General Health Among Patients Seeking Musculoskeletal Specialty Care. Clin Orthop Relat Res. 2025 Apr 1;483(4):647-663. doi: 10.1097/CORR.0000000000003394. Epub 2025 Feb 5.
- Teunis T, Al Salman A, Koenig K, Ring D, Fatehi A. Unhelpful Thoughts and Distress Regarding Symptoms Limit Accommodation of Musculoskeletal Pain. Clin Orthop Relat Res. 2022 Feb 1;480(2):276-283. doi: 10.1097/CORR.0000000000002006.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00008863
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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