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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05696964
Other study ID # IRB-2022-220
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date February 1, 2024

Study information

Verified date March 2024
Source Wright State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research aims to optimize patient-clinician relationships through motivational interviewing training in a Federally Qualified Health Center (FQHC) to improve health outcomes for African American patients with Type 2 diabetes.


Description:

Motivational Interviewing (MI) is an evidence-based approach that has been demonstrated to increase both the patient engagement and activation necessary for effective management of chronic conditions, but is underutilized due to the inadequate training of and implementation by health professionals. This research aims to optimize patient-clinician relationships through MI training in a Federally Qualified Health Center (FQHC) to improve health outcomes for African American patients with Type 2 diabetes. MI training and cuing in this study will make use of a human-artificial intelligence (AI) teaming solution, Real-time Assessment of Dialogue in Motivational Interviewing (ReadMI), a tool that uses natural language processing to provide automatic and immediate metrics relevant for patient-clinician interaction.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Eligible participants are residents in Family Medicine and Internal Medicine residency programs at Wright State University who will be recruited to participate in the study. Exclusion Criteria: - None Note: Patients of these participating residents will be invited to participate in the study by providing survey and health data at specified intervals, but these patients will not be the direct recipients of any intervention in this study. Eligible patients will be self-identifying African American individuals ages 18 and over with a diagnosis of Type 2 diabetes, and are patients of either Family Medicine or Internal Medicine residents participating in this study. The target number of patients is 200.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational interviewing training enhanced with artificial intelligence
The training in motivational interviewing that medical residents will receive will make use of an artificial intelligence measurement tool, Real-time Assessment of Dialogue in Motivational Interviewing (ReadMI), that produces a spectrum of relevant MI metrics.

Locations

Country Name City State
United States Five Rivers Health Centers Dayton Ohio
United States Wright State University Dayton Ohio

Sponsors (3)

Lead Sponsor Collaborator
Wright State University Five Rivers Health Centers, Kennesaw State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hershberger PJ, Pei Y, Bricker DA, Crawford TN, Shivakumar A, Vasoya M, Medaramitta R, Rechtin M, Bositty A, Wilson JF. Advancing Motivational Interviewing Training with Artificial Intelligence: ReadMI. Adv Med Educ Pract. 2021 Jun 4;12:613-618. doi: 10.2147/AMEP.S312373. eCollection 2021. — View Citation

Vasoya MM, Shivakumar A, Pappu S, Murphy CP, Pei Y, Bricker DA, Wilson JF, Castle A, Hershberger PJ. ReadMI: An Innovative App to Support Training in Motivational Interviewing. J Grad Med Educ. 2019 Jun;11(3):344-346. doi: 10.4300/JGME-D-18-00839.1. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in perceptions of the patient-clinician relationship by patients of participating residents. The Patient-Doctor Relationship Questionnaire-9 (PDRQ-9) will be used to assess the patient's subjective perception of the quality of the patient-clinician relationship.The PDRQ-9 consists of 9 statements, for which there are response options ranging from 1 (not at all appropriate) to 5 (totally appropriate). Scores range from 9 to 45 with higher scores being more desirable. Measured every 3 months up to 4 years.
Secondary Perceptions of psychological safety by patients of participating residents. The Patient Psychological Safety Scale, developed by the investigators, contains 13 items for which responses can range from 1 (Strongly disagree) to 5 (Strongly agree). Four items are reverse-scored. The minimum value is 13 and the maximum value is 65. Higher scores mean greater perceptions of psychological safety, a desired state. Measured every 3 months up to 4 years.
Secondary Levels of self-reported patient activation by patients of participating residents. The Patient Activation Measure (PAM-13) will be used to assess the patient's knowledge, skills, and confidence which is integral to managing their own health. The PAM-13 consists of 13 statement for which each has four response options, ranging from 1 (Disagree strongly) to 4 (Agree strongly), as well as a not applicable (n/a) option. Scores range from 13 to 52, with higher scores being more desirable. Measured every 3 months up to 4 years.
Secondary HbA1c levels of patients of participating residents. This measures the amount of blood sugar (glucose) attached to hemoglobin, and functions as an indicators of how well diabetes is being controlled. Measured every 3 months up to 4 years.
Secondary Changes in the percentage of time the resident speaks in role plays in motivational interviewing practice. Clinician motivational interviewing skills will be measured using Real-time Evaluation of Dialogue in Motivational Interviewing (ReadMI), software that produces communication metrics, including the percentage of time the clinician speaks versus the patient speaking time. Percentage can range fro 0% to 100%, with the most desirable range being 33%. Measured every 3 months up to 3 years.
Secondary Changes in the ratio of open-ended to closed-ended questions used by the resident in role plays in motivational interviewing practice. Clinician motivational interviewing skills will be measured using Real-time Evaluation of Dialogue in Motivational Interviewing (ReadMI), software that produces communication metrics, including the ratio of open-ended to closed-ended questions. Ratios can range from 0 to infinity, with the most desirable ration being in the 5:1 or higher range. Measured every 3 months up to 3 years.
Secondary Changes in the ratio of reflections to questions used by the resident in role plays in motivational interviewing practice. Clinician motivational interviewing skills will be measured using Real-time Evaluation of Dialogue in Motivational Interviewing (ReadMI), software that produces communication metrics, including the ratio of reflective statements to questions. Ratios can range from 0 to infinity, with the most desirable ratio being greater than 1. Measured every 3 months up to 3 years.
Secondary Changes in the "spirit of motivational interviewing" rating given to the resident by the facilitator in role plays in motivational interviewing practice. The "spirit of motivational interviewing" rating refers to the facilitator's perception of the degree to which the clinician communicates with the patient in a manner that is aimed as creating a need for change on the part of the patient, highlights the patient's autonomy and choice, and minimizes default use of education and advice. Ratings are on a 1 to 10 scale, with 10 being the most desirable rating. Measured every 3 months up to 3 years.
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