University of California Davis Health
Sacramento, California, 95817, United States
NCT Number: NCT06778486
The goal of this clinical trial is to assess the use of a generative artificial intelligence large language model chatbot in improving decision making factors in patients with hip and knee osteoarthritis. The main questions it aims to answer are:
Does the use of an artificial intelligence chatbot have an effect on decisional conflict and anxiety related to decision making? Are changes in decisional conflict correlated with changes in patient reported outcomes? Are changes in decisional conflict correlated with health literacy? Participants will interact with an artificial intelligence chatbot prior to their clinic visit with an orthopaedic surgeon, using a structured prompt.
This study is active but is not currently recruiting participants.
Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Sacramento, California, 95817, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention is a generative artificial intelligence large language model chatbot that has a structured prompt with fill-in-the-blank style questions that the participant will complete.
Time frame: At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.
16 questions with Likert scale style answers ranging from 0 to 4. The raw score is converted to a score out of 100. The score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Time frame: At three time points: Within one week after the clinic visit, 1 month after the clinic visit, 6 months after the clinic visit.
21 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (low anxiety) to 63 (high anxiety).
Time frame: At enrollment
7 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (total knee disability) to 100 (perfect knee health).
Time frame: At enrollment
6 questions with Likert scale style answers ranging from 0 to 4. The raw score is the sum of the answers, which is converted to a score out of 100. The score ranges from 0 (total hip disability) to 100 (perfect hip health).
Time frame: At enrollment
10 questions with Likert scale style answers ranging from 1 to 5 and 1 question about pain with answers from 0 to 10. The questions are grouped into 4 sub-groups corresponding to physical and mental health main groups, in addition to the pain score. The raw scores are a sum of the answers for both physical and mental health range from 4 (poor physical or mental health) to 20 (best possible physical or mental health). The raw score is then converted to a t-score using the associated tables with the range 16.2 (worst possible physical or mental health) to 67.7 (best possible physical or mental health). The t-score is interpreted in comparison to the general population that has a mean of 50 and standard deviation of 10.
Time frame: At enrollment
3 questions evaluating pain and different time points, each with answers ranging from 0 (no pain) to 100 (worst pain imaginable).
Time frame: At enrollment
Both questions 1 and 2 have Likert scale style answers from 1 (limited ability to navigate healthcare scenarios independently) to 5 (adequate ability to navigate healthcare scenarios independently).
Time frame: At enrollment
This measure involves participants answering a series of questions based on their interpretation of a nutrition label. It includes 5 primary questions with an additional conditional question, making up to 6 questions in total, depending on the participant's responses. This assessment is designed to evaluate health literacy, specifically the ability to understand and apply nutritional information. The score is the sum of the correct answers, ranging from 0 (indicating limited health literacy) to 6 (indicating adequate health literacy).
Time frame: At enrollment
9 questions each with 4 answers, in addition to an "I don't know" selection. The total score is the sum of the correct answers ranging from 0 (poor musculoskeletal health literacy) to 9 (excellent musculoskeletal health literacy).
Time frame: At the first clinic visit after enrollment
7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. The test is administered in-person by a clinician. The participant is given a list of words by a clinician and asked to pronounce the words. The clinician listens and evaluates the number of words the participant pronounces correctly and the total score is based on the number of words that are correctly pronounced. A higher score is indicative of higher health literacy. The maximum score of 7 is correlated with high health literacy equivalent to high school education or greater, and a participants ability to read most patient education materials. The minimum score of 0 is associated with low health literacy equivalent to third grade education or below, and a participants inability to read most low-literacy patient education materials.
Time frame: Within 1 month of AI chatbot use
This test will be used to evaluate the readability of the chatbot outputs that are presented to the participants, and will be conducted by an investigator. This test analyzes free text and determines a readability score ranging from 0 (very difficult to read) to 100 (very easy to read), and corresponds to the education level required to read the text.
Time frame: Within 1 month of AI chatbot use
This test will be used to evaluate the readability of the chatbot outputs that are presented to the participants and it will be conducted by an investigator. This test analyzes free text and determines a readability score with a minimum of 4.1721 and a maximum that is theoretically infinite. The number of the score is equivalent to the approximate school grade level required to read the text.
Time frame: Within 1 week of AI chatbot use
This safety evaluation tool will be used by a physician to assess chatbot outputs that are presented to the participant with a Likert scale ranging from 0 (no likelihood of harm) to 5 (high likelihood of harm).
University of California, Davis
Other
CHAT-OA: Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients
Acronym: CHAT-OA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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