AzTrials
AzTrials

Physician-Patient RelationsIRMITNCT05696964

Improving Relationships Using Motivational Interviewing

A study testing Motivational interviewing training enhanced with artificial intelligence in people with Physician-Patient Relations and Diabetes Mellitus, Type 2, run by Wright State University at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
What is being tested?
Motivational interviewing training enhanced with artificial intelligence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
1 Feb 2024to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Five Rivers Health Centers

    Dayton, Ohio, 45417

  • Wright State University

    Dayton, Ohio, 45435

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Motivational interviewing training enhanced with artificial intelligence
Keywords
motivational interviewing, patient-clinician relationship, artificial intelligence
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Motivational interviewing training enhanced with artificial intelligenceBehavioural

    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.

Study groups in NCT05696964
Study groupRoleWhat they receive
Enhanced Motivational Interviewing TrainingExperimentalParticipating 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.
Receives: Behavioral: Motivational interviewing training enhanced with artificial intelligence

What is being measured

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

  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: Measured every 3 months up to 4 years.

Secondary outcomes (7)

  1. 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.

    Measured: Measured every 3 months up to 4 years.

  2. 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.

    Measured: Measured every 3 months up to 4 years.

  3. 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.

    Measured: Measured every 3 months up to 4 years.

  4. 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%.

    Measured: Measured every 3 months up to 3 years.

  5. 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.

    Measured: Measured every 3 months up to 3 years.

  6. 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.

    Measured: Measured every 3 months up to 3 years.

  7. 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.

    Measured: Measured every 3 months up to 3 years.

Timeline

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

  1. First posted25 Jan 2023
  2. Study start1 Feb 2024 (estimated)
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Why it stopped: The research study was not funded.

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
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696964
Sponsor's protocol ID
IRB-2022-220
Acronym
IRMIT
Status last verified
Mar 2024
First submitted
22 Dec 2022
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Deidentified group data will be made available to other researchers but no individual participant data will be shared.

Publications

  • 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.

    PubMed 31210875

  • 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.

    PubMed 34113205

Questions about this trial

What is this clinical trial studying?

A study testing Motivational interviewing training enhanced with artificial intelligence in people with Physician-Patient Relations and Diabetes Mellitus, Type 2, 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 2 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: withdrawn, as of the sponsor's last update on 5 Mar 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in perceptions of the patient-clinician relationship by patients of participating residents. (time frame: Measured every 3 months up to 4 years.). 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 NCT05696964, which also lists 2 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 5 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

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