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Improving Relationships Using Motivational Interviewing (IRMIT)

Primary Purpose

Physician-Patient Relations, Diabetes Mellitus, Type 2

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational interviewing training enhanced with artificial intelligence
Sponsored by
Wright State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physician-Patient Relations focused on measuring motivational interviewing, patient-clinician relationship, artificial intelligence

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Five Rivers Health Centers
  • Wright State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enhanced Motivational Interviewing Training

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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%.
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.
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.
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.

Full Information

First Posted
December 22, 2022
Last Updated
January 20, 2023
Sponsor
Wright State University
Collaborators
Five Rivers Health Centers, Kennesaw State University
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1. Study Identification

Unique Protocol Identification Number
NCT05696964
Brief Title
Improving Relationships Using Motivational Interviewing
Acronym
IRMIT
Official Title
A Multilevel Approach to Improving Patient-Clinician Relationships and Outcomes in African American Patients With Diabetes Using Artificial Intelligence-Enhanced Motivational Interviewing Training
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wright State University
Collaborators
Five Rivers Health Centers, Kennesaw State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physician-Patient Relations, Diabetes Mellitus, Type 2
Keywords
motivational interviewing, patient-clinician relationship, artificial intelligence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Motivational Interviewing Training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational interviewing training enhanced with artificial intelligence
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in perceptions of the patient-clinician relationship by patients of participating residents.
Description
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.
Time Frame
Measured every 3 months up to 4 years.
Secondary Outcome Measure Information:
Title
Perceptions of psychological safety by patients of participating residents.
Description
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.
Time Frame
Measured every 3 months up to 4 years.
Title
Levels of self-reported patient activation by patients of participating residents.
Description
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.
Time Frame
Measured every 3 months up to 4 years.
Title
HbA1c levels of patients of participating residents.
Description
This measures the amount of blood sugar (glucose) attached to hemoglobin, and functions as an indicators of how well diabetes is being controlled.
Time Frame
Measured every 3 months up to 4 years.
Title
Changes in the percentage of time the resident speaks in role plays in motivational interviewing practice.
Description
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%.
Time Frame
Measured every 3 months up to 3 years.
Title
Changes in the ratio of open-ended to closed-ended questions used by the resident in role plays in motivational interviewing practice.
Description
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.
Time Frame
Measured every 3 months up to 3 years.
Title
Changes in the ratio of reflections to questions used by the resident in role plays in motivational interviewing practice.
Description
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.
Time Frame
Measured every 3 months up to 3 years.
Title
Changes in the "spirit of motivational interviewing" rating given to the resident by the facilitator in role plays in motivational interviewing practice.
Description
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.
Time Frame
Measured every 3 months up to 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul J Hershberger, PhD
Phone
937-245-7223
Email
paul.hershberger@wright.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dean A Bricker, MD
Phone
937-208-2010
Email
dean.bricker@wright.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Hershberger, PhD
Organizational Affiliation
Wright State University Boonshoft School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean A Bricker, MD
Organizational Affiliation
Wright State University Boonshoft School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Five Rivers Health Centers
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina McFarlane-El, MBA,MPH
Phone
937-281-6800
Email
gina.mcfarlane-el@frhc.org
First Name & Middle Initial & Last Name & Degree
Mamle Anim, MD
Phone
937-281-6800
Email
mamle.anim@frhc.org
Facility Name
Wright State University
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45435
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul J Hershberger, PhD
Phone
937-245-7223
Email
paul.hershberger@wright.edu
First Name & Middle Initial & Last Name & Degree
Dean A Bricker, MD
Phone
937-208-2010
Email
dean.bricker@wright.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified group data will be made available to other researchers but no individual participant data will be shared.
Citations:
PubMed Identifier
31210875
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.
Results Reference
background
PubMed Identifier
34113205
Citation
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.
Results Reference
background

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Improving Relationships Using Motivational Interviewing

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