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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Virtual Standardized Patient
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.
Other: Academic Study
Study of a summary of motivational interviewing concepts and techniques.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Puget Sound Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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