AzTrials
AzTrials

Multiple Chronic ConditionsAIM-PCNCT06597123

AI-Augmented Motivational Interviewing Training for Primary Care

A study testing Basic AI (artificial intelligence)-Augmented Motivational Interviewing Training and Plus AI (artificial intelligence)-Augmented Motivational Interviewing Training in people with Multiple Chronic Conditions and Patient Engagement, run by Wright State University at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study will examine the impact of training primary care providers (PCPs) in motivational interviewing (MI) using artificial intelligence (AI) to augment the training process. MI is a patient-centered approach to engaging patients in their own care. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Basic AI (artificial intelligence)-Augmented Motivational Interviewing Training and Plus AI (artificial intelligence)-Augmented Motivational Interviewing Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesUnited States
Study dates
1 Jul 2025to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Eligible PCPs who opt to not provide informed consent for participation will be excluded from the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paul J Hershberger, PhD contact

937-245-7223

paul.hershberger@wright.edu

Mary Crane, MBA contact

937-245-7218

mary.crane@wright.edu

United States2 sites
  • Premier Health

    Dayton, Ohio, 45409

    Joseph P Allen, MD, jpallen@premierhealth.com

    Brian M Schulze, bmschulze@premierhealth.com

  • Wright State University

    Dayton, Ohio, 45435

    Paul J Hershberger, PhD, 937-245-7223, paul.hershberger@wright.edu

    Mary Crane, MBA, 937-245-7218, mary.crane@wright.edu

Other trials in United States

About this study

This study will examine the impact of training primary care providers (PCPs) in motivational interviewing (MI) using artificial intelligence (AI) to augment the training process. MI is a patient-centered approach to engaging patients in their own care. There will be a control group and two intervention groups, with the intervention groups receiving a different amount of MI training. The hypothesis is that the AI-augmented MI training will result in improved patient outcomes, improved clinician wellbeing, and reduced behavioral manifestation of clinician biases. This mixed-methods project will also collect qualitative data from structured interviews and focus groups with participating PCPs to examine perceived facilitators and barriers to the use of the MI approach in primary care.

Read the 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.

Being tested
Basic AI (artificial intelligence)-Augmented Motivational Interviewing Training, Plus AI (artificial intelligence)-Augmented Motivational Interviewing Training
Keywords
Motivational Interviewing, Artificial Intelligence, Multiple Chronic Conditions, Clinician Wellbeing, Biases, Patient Engagement
Medical subject headings
Multiple Chronic Conditions, Patient Participation, Burnout, Professional, Bias, Implicit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic AI (artificial intelligence)-Augmented Motivational Interviewing TrainingBehavioural

    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.

  • Plus AI (artificial intelligence)-Augmented Motivational Interviewing TrainingBehavioural

    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.

Study groups in NCT06597123
Study groupRoleWhat they receive
Control GroupNo interventionThe 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.
BASIC AI-Augmented Motivational Interviewing TrainingActive comparatorThe 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.
Receives: Behavioral: Basic AI (artificial intelligence)-Augmented Motivational Interviewing Training
PLUS AI-Augmented Motivational Interviewing TrainingActive comparatorThe 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.
Receives: Behavioral: Plus AI (artificial intelligence)-Augmented Motivational Interviewing Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MI Communication Metrics

    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.

    Measured: Months 4-7, Months 16-20, Months 30-33

  2. MI Spirit

    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.

    Measured: Months 4-7, Months 16-20, Months 30-33

Secondary outcomes (9)
  1. Bias Manifestation

    Dougall GPT will be used to identify the number of biases evident in a role play with a standardized patient.

    Measured: Months 4-7, Months 16-20, Months 30-33

  2. Mini Z (Zero) Burnout Scale 2.0

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  3. Aggregated Patient Data for Each Participating PCP

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  4. Perceived Stress Scale (PSS)

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  5. Brief Resilience Scale (BRS)

    Six-item scale (5 pt Likert scale) assessing responses to stressful periods. Scores range from 6-30 with higher scores indicating more resilience.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  6. Clinician Support for Patient Activation Measure (CS-PAM)

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  7. Stress Mindset Measure (SMM)

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  8. MI Survey Measure

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

  9. Diversity Awareness Self-Reflection Tool (DASRT)

    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.

    Measured: Months 4-5, Months 16-17, Months 25-26, Months 32-33

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Primary care provider (PCP) participants will be randomly assigned to intervention (IG) or control (CG) groups, with the Basic IG receiving two ReadMI (Real-time Evaluation of Dialogue in Motivational Interviewing)-supported motivational interviewing (MI) trainings and the Plus IG receiving four MI trainings. Plus will receive two MI trainings at the same time as Basic and will receive two additional MI trainings one year later.
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06597123
Sponsor's protocol ID
25-0047-P0001
Acronym
AIM-PC
Status last verified
Sep 2024
First submitted
5 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Only aggregate participant data will be made available to other researchers.

Publications

  • 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.

    PubMed 24001658
  • 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.

    PubMed 38443862
  • 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.

    PubMed 34457961
  • 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.

    PubMed 23576243
  • 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.

    PubMed 33860162

Questions about this trial

What is this clinical trial studying?

A study testing Basic AI (artificial intelligence)-Augmented Motivational Interviewing Training and Plus AI (artificial intelligence)-Augmented Motivational Interviewing Training in people with Multiple Chronic Conditions and Patient Engagement, run by Wright State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paul J Hershberger, PhD (937-245-7223, paul.hershberger@wright.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MI Communication Metrics (time frame: Months 4-7, Months 16-20, Months 30-33). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06597123, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in