Improving Relationships Using Motivational Interviewing (IRMIT)

March 1, 2024 updated by: Wright State University

A Multilevel Approach to Improving Patient-Clinician Relationships and Outcomes in African American Patients With Diabetes Using Artificial Intelligence-Enhanced Motivational Interviewing Training

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Motivational Interviewing Training
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in perceptions of the patient-clinician relationship by patients of participating residents.
Time Frame: Measured every 3 months up to 4 years.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceptions of psychological safety by patients of participating residents.
Time Frame: Measured every 3 months up to 4 years.
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.
Levels of self-reported patient activation by patients of participating residents.
Time Frame: Measured every 3 months up to 4 years.
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.
HbA1c levels of patients of participating residents.
Time Frame: Measured every 3 months up to 4 years.
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.
Changes in the percentage of time the resident speaks in role plays in motivational interviewing practice.
Time Frame: Measured every 3 months up to 3 years.
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.
Changes in the ratio of open-ended to closed-ended questions used by the resident in role plays in motivational interviewing practice.
Time Frame: Measured every 3 months up to 3 years.
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.
Changes in the ratio of reflections to questions used by the resident in role plays in motivational interviewing practice.
Time Frame: Measured every 3 months up to 3 years.
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.
Changes in the "spirit of motivational interviewing" rating given to the resident by the facilitator in role plays in motivational interviewing practice.
Time Frame: Measured every 3 months up to 3 years.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wright State University

Collaborators

Kennesaw State University
Five Rivers Health Centers

Investigators

  • Principal Investigator: Paul J Hershberger, PhD, Wright State University Boonshoft School of Medicine
  • Principal Investigator: Dean A Bricker, MD, Wright State University Boonshoft School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Actual)

February 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2022-220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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