- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558060
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
Completed
Conditions
Intervention / Treatment
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.
Clinical Trials on Motivational Interviewing
-
University of ManitobaActive, not recruiting
-
Auburn UniversityCompletedCardiac Rehabilitation | Motivational InterviewingUnited States
-
Université de SherbrookeCHU de Quebec-Universite Laval; McGill University Health Centre/Research Institute... and other collaboratorsCompletedMotivational InterviewingCanada
-
University of Colorado, DenverDuke UniversityCompleted
-
Karadeniz Technical UniversityNot yet recruitingMotivational Interviewing (MI)Turkey (Türkiye)
-
Kahramanmaraş İstiklal UniversityRecruitingCOPD | Motivational InterviewingTurkey
-
Gazi UniversityCompletedMotivational Interviewing | Nursing Care | Lumbar Disc SurgeryTurkey (Türkiye)
-
Mersin UniversityCompletedBreastfeeding Counseling Based on Motivational InterviewingTurkey
-
Celal Bayar UniversityCompletedSmoking | Motivational Interviewing | Nursing | School HealthTurkey
-
University of MinnesotaCompleted
Clinical Trials on Virtual Standardized Patient
-
Wang ShalongCompletedMedical Education | Clinical Communication | Breaking Bad News SkillsChina
-
BaycrestCompletedPsychological Distress | End-of-Life | Physical SufferingCanada
-
National Taiwan University HospitalEnrolling by invitationEducation, MedicalTaiwan
-
Institut fuer FrauengesundheitLilly Deutschland GmbH GermanyNot yet recruitingHR+/HER2- Early Breast CancerGermany
-
Sinop UniversityNot yet recruitingCommunication | Satisfaction | Confidence, SelfTurkey
-
Ankara Yildirim Beyazıt UniversityCompleted
-
RANDActive, not recruiting
-
Aybike CiciKafkas UniversityRecruitingColostomy StomaTurkey (Türkiye)
-
Yuksek Ihtisas UniversitySaglik Bilimleri UniversitesiCompletedAnxiety | Self Efficacy | Patient Simulation | Pediatric Nursing | High Fidelity Simulation TrainingTurkey
-
University of RochesterCompleted