NCT05696964

Brief 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

December 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

Same day

First QC Date

December 22, 2022

Last Update Submit

March 1, 2024

Conditions

Keywords

motivational interviewingpatient-clinician relationshipartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Perceptions of psychological safety by patients of participating residents.

    Measured every 3 months up to 4 years.

  • Levels of self-reported patient activation by patients of participating residents.

    Measured every 3 months up to 4 years.

  • HbA1c levels of patients of participating residents.

    Measured every 3 months up to 4 years.

  • Changes in the percentage of time the resident speaks in role plays in motivational interviewing practice.

    Measured every 3 months up to 3 years.

  • Changes in the ratio of open-ended to closed-ended questions used by the resident in role plays in motivational interviewing practice.

    Measured every 3 months up to 3 years.

  • +2 more secondary outcomes

Study Arms (1)

Enhanced Motivational Interviewing Training

EXPERIMENTAL

Participating medical residents will all receive two successive interventions, motivational interviewing (MI) booster training and the use of a dashboard that provides MI metrics. The booster training will make use of an artificial intelligence tool developed by our study team, Real-time Assessment of Dialogue in Motivational Interviewing (ReadMI), that produces metrics on important conversational skills (e.g., talking time, use of open-ended questions). The dashboard will produce these metrics during clinical encounters as a way to provide cuing for the MI approach.

Behavioral: Motivational interviewing training enhanced with artificial intelligence

Interventions

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.

Enhanced Motivational Interviewing Training

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Five Rivers Health Centers

Dayton, Ohio, 45417, United States

Location

Wright State University

Dayton, Ohio, 45435, United States

Location

Related Publications (2)

  • 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.

    PMID: 31210875BACKGROUND
  • 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.

    PMID: 34113205BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Paul J Hershberger, PhD

    Wright State University Boonshoft School of Medicine

    PRINCIPAL INVESTIGATOR
  • Dean A Bricker, MD

    Wright State University Boonshoft School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participating medical residents in the study will receive the same motivational interviewing training. Patients of these medical residents will be recruited to provide data on their perceptions of their relationship with their physician, as well as health indicators, but there is no direct intervention for patients themselves. The target number of patients is 200.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 25, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Deidentified group data will be made available to other researchers but no individual participant data will be shared.

Locations