NCT06108037

Brief Summary

The purpose of this study is to understand how patients feel about the use of computer programs to create responses when they send electronic messages to their doctors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,454

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2023

Completed
Last Updated

December 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 23, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

Artificial IntelligenceGenerative Artificial Intelligence

Outcome Measures

Primary Outcomes (3)

  • Patient satisfaction, as measured by survey

    Likert-scale responses to satisfaction question: "I am satisfied with this interaction", on a scale from 1-5 with answer options of Strongly Disagree (1), Disagree (2), Neither agree nor disagree (3), Agree (4), and Strongly agree (5).

    Up to 2 weeks

  • Patient attitudes towards utility, as measured by survey

    Likert-scale responses to utility question: "The information is useful", on a scale from 1-5 with answer options of Strongly Disagree (1), Disagree (2), Neither agree nor disagree (3), Agree (4), and Strongly agree (5).

    Up to 2 weeks

  • Patient empathy, as measured by survey

    Likert-scale responses to empathy question: "I feel cared for during this interaction", on a scale from 1-5 with answer options of Strongly Disagree (1), Disagree (2), Neither agree nor disagree (3), Agree (4), and Strongly agree (5).

    Up to 2 weeks

Study Arms (6)

Arm A

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm A receives AHN in Send 1, BAIC in Send 2, and CHH in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Arm B

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm B receives BHC in Send 1, CAIH in Send 2, and AAIN in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Arm C

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm C receives CHC in Send 1, AHH in Send 2, and BAIN in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Arm D

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm D receives AAIH in Send 1, BHN in Send 2, and CAIC in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Arm E

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm E receives BAIH in Send 1, CHN in Send 2, and AHC in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Arm F

OTHER

Each arm will receive 3 clinical scenarios spaced over time across 3 Sends. The 6 groups (Arms A-F) will be arranged with naming conventions as such: * First letter = A, B, or C where A = scenario 1, B = scenario 2, and C = scenario 3. * Second letter(s) = H or AI, where H = human response and AI = AI-written response to the patient question posed. * Third letter(s) = N, C, or H, where N = no disclosure, C = computer disclosure, and H = human disclosure. This refers to the disclosure at the bottom of the response message whereby the author is or is not disclosed. Arm F receives CAIN in Send 1, AAIC in Send 2, and BHH in Send 3

Behavioral: Generative AI for electronic communication and disclosure

Interventions

We will use a large language model such as GPT 3.5 to automatically generate responses to fictional messages to a physician. We will disclose whether the message was generated using this technology or not. There are 3 clinical scenarios and 6 pairs of human/AI response and human disclosure/AI disclosure/not disclosed that will test patient attitudes toward this technology.

Arm AArm BArm CArm DArm EArm F

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of the Duke Health Listens patient advocacy community

You may not qualify if:

  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

  • Ayers JW, Poliak A, Dredze M, Leas EC, Zhu Z, Kelley JB, Faix DJ, Goodman AM, Longhurst CA, Hogarth M, Smith DM. Comparing Physician and Artificial Intelligence Chatbot Responses to Patient Questions Posted to a Public Social Media Forum. JAMA Intern Med. 2023 Jun 1;183(6):589-596. doi: 10.1001/jamainternmed.2023.1838.

    PMID: 37115527BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Anand Chowdhury, MD, MMCi

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not be aware of the arm they are assigned to. There is no care provider or outcomes assessor in this study, as the patients will report their own perceptions in a survey.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: * Participants will be randomly allocated to one of six arms. * Over the course of the study period, there will be multiple rounds of surveys, which will consist of a clinical scenario, a response (human or AI generated), and a disclosure statement (none, human, or AI). * All respondents within an arm will be assigned to a sequence of response-disclosure pairs prior to the first round of surveys.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 30, 2023

Study Start

October 31, 2023

Primary Completion

December 11, 2023

Study Completion

December 11, 2023

Last Updated

December 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

The investigators will not collect individual patient identifiers, and aggregate data will be reported

Locations