NCT04558060

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

September 8, 2020

Last Update Submit

September 15, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Difference in Motivational Interviewing Treatment Integrity 4.2.1 between the conditions

    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

    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

    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 Outcomes (16)

  • Difference in Helpful Responses Questionnaire between the conditions

    Change in Helpful Responses Questionnaire from Baseline to post-training [approximately 2-weeks after baseline]

  • Difference in Helpful Responses Questionnaire between the conditions

    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

    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

    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

    Change in Motivational Interviewing Self-efficacy Scale from Baseline to 3-month follow-up training [approximately 3.5-months after baseline]

  • +11 more secondary outcomes

Study Arms (2)

Virtual Standardized Patient

EXPERIMENTAL

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

Academic Study

ACTIVE COMPARATOR

Study of a summary handout of motivational interviewing concepts and techniques for 45-minutes.

Other: Academic Study

Interventions

Computer program that presented a virtual human patient

Virtual Standardized Patient

Study of a summary of motivational interviewing concepts and techniques.

Academic Study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Reger GM, Norr AM, Rizzo AS, Sylvers P, Peltan J, Fischer D, Trimmer M, Porter S, Gant P, Baer JS. Virtual Standardized Patients vs Academic Training for Learning Motivational Interviewing Skills in the US Department of Veterans Affairs and the US Military: A Randomized Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2017348. doi: 10.1001/jamanetworkopen.2020.17348.

Study Officials

  • Greg Reger, PhD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Motivational interviewing skill is coded by assessors blind to training condition and assessment time point.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Associate Chief of Staff

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 22, 2020

Study Start

October 17, 2016

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

September 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share