- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06597123
AI-Augmented Motivational Interviewing Training for Primary Care (AIM-PC)
Study Overview
Status
Conditions
Detailed Description
Motivational interviewing (MI) is an evidence-based patient-centered approach that has been demonstrated to be effective in increasing patient engagement in their own care. Using MI, a clinician is compassionate curious to understand patients' perspective on their behavior, and conversationally guides them to discover a need for behavior change. However, MI is not widely utilized in primary care practices and challenging to teach, in part because many primary care providers (PCPs) take a direct approach with their patients by educating and advising them regarding steps to improve their health. However, simply telling patient what to do tends to be ineffective, leading to frustration on the part of both patients and PCPs.
To help implement the MI approach more widely, our team has developed an artificial intelligence (AI) augmented tool for MI skill development, ReadMI™ (Real-time Assessment of Dialogue in Motivational Interviewing). The goal of this project is to: 1) examine the association of AI-measured proficiency in MI to patient outcomes, PCP wellbeing, and PCP manifestations of bias, and 2) to determine the extent to which AI-augmented MI skills training can impact the same outcome, wellbeing, and bias manifestation variables in a randomized controlled trial (RCT). This mixed-methods project will also employ structured interviews and focus groups of participating PCPs to collect qualitative data for better understanding both facilitators and barriers to the implementation of MI in primary care.
The overall hypothesis is that PCPs with the strongest MI proficiencies will have patients with better outcomes, and that those PCPs will also demonstrate less burnout and less manifestation of bias. Additionally, it is hypothesized that making use of AI in MI training will be seen by PCPs as a facilitator to the use of MI in their practices.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul J Hershberger, PhD
- Phone Number: 937-245-7223
- Email: paul.hershberger@wright.edu
Study Contact Backup
- Name: Mary Crane, MBA
- Phone Number: 937-245-7218
- Email: mary.crane@wright.edu
Study Locations
-
-
Ohio
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Dayton, Ohio, United States, 45435
- Wright State University
-
Contact:
- Paul J Hershberger, PhD
- Phone Number: 937-245-7223
- Email: paul.hershberger@wright.edu
-
Contact:
- Mary Crane, MBA
- Phone Number: 937-245-7218
- Email: mary.crane@wright.edu
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Dayton, Ohio, United States, 45409
- Premier Health
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Contact:
- Joseph P Allen, MD
- Email: jpallen@premierhealth.com
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Contact:
- Brian M Schulze
- Email: bmschulze@premierhealth.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary care providers (physicians, physician assistants, and nurse practitioners) employed in primary care practices of the Premier Physician Network of Premier Health (southwest Ohio) are eligible to participate.
Exclusion Criteria:
- Eligible PCPs who opt to not provide informed consent for participation will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The control group (CG) will provide survey data and complete role plays with standardized patients for motivational interviewing (MI) assessment at designated project intervals.
Premier Physician Network data for these primary care providers (PCPs) will also be obtained at these intervals.
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|
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Active Comparator: BASIC AI-Augmented Motivational Interviewing Training
The Basic intervention group will provide survey data and complete role plays with standardized patients for motivational interviewing (MI) assessment at designated project intervals.
Premier Physician Network data for these primary care providers (PCPs) will also be obtained at these intervals.
Basic PCPs will participate in a didactics session on MI, and subsequently complete two AI (artificial intelligence)-augmented MI training sessions that involve role-play practice of MI.
|
Basic participants will participate in two motivational interviewing (MI) training sessions that involve role-play practice of MI.
Artificial intelligence (AI) will be used to provide metrics on MI-skills (percentage of the time the clinician talks, use of open-ended questions, use of closed-ended questions, use of reflective statements, use of 0-10 scales) as measured by the ReadMI™ tool (Real-time Evaluation of Dialogue in Motivational Interviewing), and both the spirit of MI and presence of bias as measured by Dougall GPT.
|
|
Active Comparator: PLUS AI-Augmented Motivational Interviewing Training
The Plus intervention group will provide survey data and complete role plays with standardized patients for motivational interviewing (MI) assessment at designated project intervals.
Premier Physician Network data for these primary care providers (PCPs) will also be obtained at these intervals.
Plus intervention group PCPs will participate in a didactics session on MI, and subsequently complete four AI (artificial intelligence)-augmented MI training sessions that involve role-play practice of MI.
|
Plus participants will participate in four motivational interviewing (MI) training sessions that involve role-play practice of MI.
Artificial intelligence (AI) will be used to provide metrics on MI-skills (percentage of the time the clinician talks, use of open-ended questions, use of closed-ended questions, use of reflective statements, use of 0-10 scales) as measured by the ReadMI™ tool, and both the spirit of MI and presence of bias as measured by Dougall GPT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MI Communication Metrics
Time Frame: Months 4-7, Months 16-20, Months 30-33
|
Motivational interviewing skills/metrics (percentage of time the clinician speaks, number of open-ended questions, number of close-ended questions, number of reflective statements, number of 0-10 scales).
Each of the metrics is the total number of occurrences.
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Months 4-7, Months 16-20, Months 30-33
|
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MI Spirit
Time Frame: Months 4-7, Months 16-20, Months 30-33
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Using a 0-10 scale, the spirit of motivational interviewing (MI) in a role play with a standardized patient will be measured by two artificial intelligence (AI) tools respectively: ReadMI and Dougall GPT.
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Months 4-7, Months 16-20, Months 30-33
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bias Manifestation
Time Frame: Months 4-7, Months 16-20, Months 30-33
|
Dougall GPT will be used to identify the number of biases evident in a role play with a standardized patient.
|
Months 4-7, Months 16-20, Months 30-33
|
|
Mini Z (Zero) Burnout Scale 2.0
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
Ten survey questions (5 pt Likert scale) assessing perceived burnout and factors contributing to burnout.
Scores range from 10-50, with 10 indicating the least amount of burnout.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
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Aggregated Patient Data for Each Participating PCP
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
Data routinely collected by the Premier Physician Network for participating primary care providers (PCPs).
All measures are percentages of patients 0% - 100%) indicating that their PCP listened, explained things clearly, and would recommend the PCP).
Also, percentages of patients (0%-100%) of patients with poor hemoglobin A1c control, with hypertension control, and completing recommended screenings for each participating PCP are provided.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
|
Perceived Stress Scale (PSS)
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
Scale with 10 items (4 pt Likert scale) measuring perceived experience of stress.
Scores range from 0-40 with 0 being the least amount of stress.
|
Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
|
Brief Resilience Scale (BRS)
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
Six-item scale (5 pt Likert scale) assessing responses to stressful periods.
Scores range from 6-30 with higher scores indicating more resilience.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
|
Clinician Support for Patient Activation Measure (CS-PAM)
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
This 13-item scale (response options range from 1 = not important to 4 = extremely important) assesses PCP (primary care provider) attitudes and self-reported behaviors related the patient engagement in the management of their health conditions.
Scores are translated into a 1-100 scale (Rasch methods) with higher scores indicating more positive beliefs about patients' invovlement in their care.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
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Stress Mindset Measure (SMM)
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
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This 8-item (5 pt Likert scale ranging from 0=strongly disagree to 4=strongly agree) measures perspectives on stress as debilitating versus enhancing.
Scores range from 0 to 32 with higher scores indicating a mindset that stress is enhancing.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
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MI Survey Measure
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
|
Three items (5 pt Likert scale) assess PCP (primary care provider) attitudes regarding the impact of motivational interviewing (MI) training on confidence, intent to use/incorporation of the MI approach, and importance of MI training for other PCPs.
Scores range from 3 to 15 with higher scores indicating more positive regard for MI.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
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Diversity Awareness Self-Reflection Tool (DASRT)
Time Frame: Months 4-5, Months 16-17, Months 25-26, Months 32-33
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SeventeenValues and Attitudes items (three response alternatives for each item ranging from 1=things I do often to 3=things I do rarely) from the Diversity Awareness Self-Reflection Tool will be used to assess PCP (primary care provider) self-awareness of their attitudes and behavior toward patient of diverse backgrounds.
Scores range from 17 to 51 with lower scores indicating a higher degree of diversity competency.
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Months 4-5, Months 16-17, Months 25-26, Months 32-33
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul J Hershberger, PhD, Wright State University Boonshoft School of Medicine
Publications and helpful links
General Publications
- Chapman EN, Kaatz A, Carnes M. Physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities. J Gen Intern Med. 2013 Nov;28(11):1504-10. doi: 10.1007/s11606-013-2441-1. Epub 2013 Apr 11.
- Lundahl B, Moleni T, Burke BL, Butters R, Tollefson D, Butler C, Rollnick S. Motivational interviewing in medical care settings: a systematic review and meta-analysis of randomized controlled trials. Patient Educ Couns. 2013 Nov;93(2):157-68. doi: 10.1016/j.pec.2013.07.012. Epub 2013 Aug 1.
- Hershberger PJ, Pei Y, Bricker DA, Crawford TN, Shivakumar A, Castle A, Conway K, Medaramitta R, Rechtin M, Wilson JF. Motivational interviewing skills practice enhanced with artificial intelligence: ReadMI. BMC Med Educ. 2024 Mar 5;24(1):237. doi: 10.1186/s12909-024-05217-4.
- Hershberger PJ, Bricker DA, Conway K, Torcasio MH. Turning "Lose-Lose" into "Win-Win": What Is Good for Them Is Good for Us! Med Sci Educ. 2021 Mar 30;31(3):1177-1181. doi: 10.1007/s40670-021-01280-4. eCollection 2021 Jun.
- Hershberger PJ, Martensen LS, Crawford TN, Bricker DA. Promoting Motivational Interviewing in Primary Care: More Than Intention. PRiMER. 2021 Feb 4;5:7. doi: 10.22454/PRiMER.2021.287928. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-0047-P0001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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