Randomized, Controlled Evaluation of a Virtual Human Patient for Provider Training in Motivational Interviewing

September 15, 2020 updated by: Greg Reger, VA Puget Sound Health Care System
The purpose of this study is to evaluate the efficacy of training with a virtual standardized patient on the acquisition and maintenance of motivational interviewing skills compared with traditional academic study.

Study Overview

Detailed Description

Motivational interviewing is an evidence-based counseling approach that aims to increase a patient's motivation to make positive health changes in their lives. A common training method for medical professionals is the use of human standardized patients, who are actors who pretend to be patients for educational interviews. Standardized patients are expensive and it is challenging to maintain an adequate pool of patient actors. Accordingly, after licensure or medical boards, health professionals typically adopt new evidence-based practices, like motivational interviewing, without human standardized patient training experiences. Given the established importance of post-training coaching and feedback to the acquisition of motivational interviewing, innovative training methods are needed. Computer virtual patients may provide a cost-effective alternative that is scalable and supports dissemination of evidence-based practices. This study will evaluate the efficacy of a virtual standardized patient, relative to academic study, for training motivational interviewing among health care professionals from the Department of Veterans Affairs and Department of Defense.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All health care staff (e.g., physicians, nurses, social workers, psychologists) from supporting service lines are eligible to participate in the study.

Exclusion Criteria:

  • 8 hours or more of formal training in MI in the year prior to baseline assessment.
  • Successfully completed participation in the VA Evidence Based Practice roll-out of MI.
  • Served as MI trainers or have conducted research on MI at any time
  • Do not anticipate being available for the full duration of the training study (according to their verbal self-report)

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Virtual Standardized Patient
Training for 45 minutes at each training time point with a computer program that presented a virtual human patient and two simulated patient encounters. The virtual standardized patient involves a branching story line. Participants select 1 of 3 computer-generated response options at each conversational pause: 1) a response that is consistent with the principles and skills of MI, 2) an MI inconsistent response, or 3) a response that is mixed - partly consistent and partly inconsistent with MI.
Computer program that presented a virtual human patient
ACTIVE_COMPARATOR: Academic Study
Study of a summary handout of motivational interviewing concepts and techniques for 45-minutes.
Study of a summary of motivational interviewing concepts and techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time Frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to post-training [approximately 2-weeks after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time Frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Change in Motivational Interviewing Treatment Integrity 4.2.1 from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions
Time Frame: Change in Motivational Interviewing Treatment Integrity 4.2.1 from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
The Motivational Interviewing Treatment Integrity 4.2.1 is a behavioral coding system for motivational interviewing (MI) skill that involves observer ratings of 4 items on a 5-point Likert-type scale and behavior counts. The 5-point scores for Cultivating Change Talk and Softening Sustain Talk are averaged for a Technical Global summary score, and 5-point scores for Partnership and Empathy are averaged for a Relational Global summary score. Behavior counts include simple reflections, complex reflections and questions posed to patients. These behavior counts generate 2 summary scores; the percentage of reflections that are complex reflections and the ratio of reflections to questions. Participants are also categorized as meeting 'fair' and 'good' MI skill proficiency cut points for each of the 4 summary scores.
Change in Motivational Interviewing Treatment Integrity 4.2.1 from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Helpful Responses Questionnaire between the conditions
Time Frame: Change in Helpful Responses Questionnaire from Baseline to post-training [approximately 2-weeks after baseline]
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Change in Helpful Responses Questionnaire from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Time Frame: Change in Helpful Responses Questionnaire from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Change in Helpful Responses Questionnaire from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Helpful Responses Questionnaire between the conditions
Time Frame: Change in Helpful Responses Questionnaire from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Open-response questionnaire measuring reflective listening skills. Six paragraphs representing discrete things people with a problem might say are presented and participants are asked to write the next thing they would say if they wanted to be helpful. Written responses are coded for the complexity of reflective listening.
Change in Helpful Responses Questionnaire from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time Frame: Change in Motivational Interviewing Self-efficacy Scale from Baseline to post-training [approximately 2-weeks after baseline]
14-item self-report measure of motivational interviewing self-efficacy
Change in Motivational Interviewing Self-efficacy Scale from Baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time Frame: Change in Motivational Interviewing Self-efficacy Scale from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
14-item self-report measure of motivational interviewing self-efficacy
Change in Motivational Interviewing Self-efficacy Scale from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Self-efficacy Scale between the conditions
Time Frame: Change in Motivational Interviewing Self-efficacy Scale from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
14-item self-report measure of motivational interviewing self-efficacy
Change in Motivational Interviewing Self-efficacy Scale from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time Frame: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to post-training [approximately 2-weeks after baseline]
Self-reported 3-item measure of MI working knowledge, skills and confidence
Change in Provider Knowledge, Skills, and Confidence Survey from baseline to post-training [approximately 2-weeks after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time Frame: Change in Provider Knowledge, Skills, and Confidence Survey from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Self-reported 3-item measure of MI working knowledge, skills and confidence
Change in Provider Knowledge, Skills, and Confidence Survey from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Knowledge, Skills, and Confidence Survey between the conditions
Time Frame: Change in Provider Knowledge, Skills, and Confidence Survey from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Self-reported 3-item measure of MI working knowledge, skills and confidence
Change in Provider Knowledge, Skills, and Confidence Survey from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time Frame: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to post-training [approximately 2-weeks after baseline]
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time Frame: Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Change in Motivational Interviewing Knowledge and Attitudes Test from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Interviewing Knowledge and Attitudes Test between the conditions
Time Frame: Change in Motivational Interviewing Knowledge and Attitudes Test from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Objective, 14-item test of motivational interviewing knowledge. The measure concludes with a list of MI consistent, inconsistent, or neutral statements and the participant is asked to identify the correct MI principles.
Change in Motivational Interviewing Knowledge and Attitudes Test from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time Frame: Change in Motivational Knowledge Test-Revised from baseline to post-training [approximately 2-weeks after baseline]
Objective, 18-item multiple choice test of motivational interviewing knowledge
Change in Motivational Knowledge Test-Revised from baseline to post-training [approximately 2-weeks after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time Frame: Change in Motivational Knowledge Test-Revised from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Objective, 18-item multiple choice test of motivational interviewing knowledge
Change in Motivational Knowledge Test-Revised from baseline to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Motivational Knowledge Test-Revised between the conditions
Time Frame: Change in Motivational Knowledge Test-Revised from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Objective, 18-item multiple choice test of motivational interviewing knowledge
Change in Motivational Knowledge Test-Revised from post-training [approximately 2-weeks after baseline] to 3-month follow-up training [approximately 3.5-months after baseline]
Difference in Provider Training Satisfaction Survey between the conditions
Time Frame: Post-training [approximately 2-weeks after baseline]
An 11-item satisfaction survey that assesses participants' satisfaction with the training provided and the degree to which the training enhanced their abilities and preparedness to use MI.
Post-training [approximately 2-weeks after baseline]

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Greg Reger, PhD, VA Puget Sound Health Care System

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.

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 (ACTUAL)

October 17, 2016

Primary Completion (ACTUAL)

August 12, 2019

Study Completion (ACTUAL)

August 12, 2019

Study Registration Dates

First Submitted

September 8, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (ACTUAL)

September 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • DM150015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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