Telesimulation and Behavioral Health

March 15, 2022 updated by: Pacific Northwest University of Health Sciences

Telesimulation and Behavioral Health: Assessment of the Integration of the Abbreviated Checklist Contextual Interview Observation Form-Adult (CIOF-A) as a Learning Tool in Interprofessional Practice & Education: A Pilot Study

This study proposes to assess attitudes, perceived proficiency, and knowledge related to telemedicine by implementing telesimulation behavioral health scenarios in a cohort of healthcare students using the Contextual Interview Observation Form.

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

According to Mental Health America, 1 in 5 adults have a mental health condition. Mental health is associated with higher incidence of chronic diseases, lower use of medical care, and one of five most costly conditions in the US in 2006 according to the American Psychological Association. The Accreditation Council for Graduate Medical Education (ACGME) has called for residents to develop an understanding of social-behavioral sciences as a basis for patient care. ACGME advises that the curriculum is extended to physical aspects of patient care as well as the emotional, social and behavioral aspects. The Society of Teachers of Family Medicine (STFM) has also suggested the importance of the psychosocial realm. According to both the ACGME and STFM, being able to glean the necessary information is an integral part of being a family doctor.

The need for healthcare providers, medical students, and residents to possess basic interviewing, counseling and agenda setting skills to ascertain the pertinent contextual (e.g., familial, social, cultural, spiritual, etc.), health behavior, and health risk factors of patients' lives, is vital to close the gap on behavioral health and chronic diseases. In order to evaluate learners' interviewing skills, the Contextual Interview Observation Form (CIOF) an observation tool was developed using Robinson, Gould, and Strosahl's (2010) interview format. The CIOF can be used to teach a contextual interview "procedure" that is organized in a logical manner with a practical format. This "contextual interview" provides a no-cost format for the learner to capture the context of patients' behaviorally influenced health concerns and is applicable during the 4-year curriculum as well as during the clerkship years.

Many Americans lack access to health care, with an even greater shortage of access to mental health providers, especially in rural and underserved areas. Improving access to behavioral health providers and recognition of mental illness via telemedicine, could lead to improved patient outcomes and cost. However, in the pedagogical course of medical education, the investigators do not provide a robust platform for teaching telemedicine. Implementing the CIOF in a telesimulation format will allow for healthcare providers, behavior health providers, medical students, and residents to practice and experience providing basic interviewing and counseling via telemedicine. According to McCoy et al, telesimulation is "a process by which telecommunication and simulation resources are utilized to provide education, training, and/or assessment to learners at an off-site location. Off-site location refers to a distant site that would preclude the education, training, and/or assessment without the use of telecommunication resources."

Pacific Northwest University of Health Sciences educates and trains healthcare professionals emphasizing service among rural and medically underserved communities throughout the Northwest. Specifically, the investigators cover rural and underserved areas in Alaska, Washington, Oregon, Montana, and Idaho. PNWU's envisioned Institute for Interprofessional Practice & Education (IIPE) focuses on cultivating healthcare teams from a variety of professional backgrounds to enhance person-centered health care. One goal of PNWU's strategic plan is to expand graduate level educational opportunities. In response to that goal, the Yakima Valley Interprofessional Practice and Education Collaborative (YVIPEC) was established in the fall of 2014 to promote the highest quality health care in the region through a culture of inclusive and collaborative interprofessional education, practice, and scholarship. Interprofessional education (IPE) fosters a team-based approach to health care which is the approach used in rural health clinics and is reported to be critical to success in working in medically underserved areas. These collaborations include:

  • Pacific Northwest University of Health Sciences (PNWU), Doctor of Osteopathic Medicine;
  • Heritage University (HU), Physician Assistant Program and Nursing Program;
  • Washington State University (WSU), Nursing Program and Pharmacy Program;
  • Central Washington University (CWU), Paramedicine Program and Dietetics Program;
  • Washington State Allied Health Center of Excellence, located at Yakima Valley College

The current PNWU College of Osteopathic Medicine (COM) curriculum includes CLIN 618, which is a second year requirement and presents a multidimensional approach to the understanding of the most common clinical entities in psychiatry and behavioral medicine. Third and fourth year courses includes BEHCS 701 Behavioral Medicine rotation which is designed for students to learn and practice skills necessary for working with patients in a mental health setting. Incorporating the COIF via telesimulation would give students, residents, and faculty the experience for use beyond course requirements and prepare them for the future of healthcare.

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.
43

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Yakima, Washington, United States, 98901
        • Pacific Northwest University of Health Sciences

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

18 years to 33 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any enrolled student at a participating program in the Yakima Valley Interprofessional Collaborative
  • Age 18-33 (focusing on the Millennial Generation)

Exclusion Criteria:

  • Able to read, write, and speak English due to the pilot nature of the study
  • Have no pending litigation with any education entity within the YVIPEC

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 Assignment
  • Masking: None (Open Label)

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.
Active Comparator: Face-to-Face
Face-to-Face Group: At the beginning of the session self-efficacy will be measured. This group will receive an instructor-led 45 minute long lecture on how to evaluate work, love, and play behavioral health form on a standardized patient. A face-to- face standardized patient scenario will test the participant on the application of work, love, and play assessment. In this scenario, the participant will meet a standardized patient in the exam room to discuss a behavioral health concern. At the end of each session (approximately 2 hours later), self-efficacy will be measured.
Other: Face-to-face
Use of face-to-face patient interview using contextual interview format.
Active Comparator: Robot
Robot Group: At the beginning of the session self-efficacy will be measured. This group will receive an instructor-led 45 minute long lecture on how to evaluate work, love, and play behavioral health form on a standardized patient. A robot (telesimulated) standardized patient scenario will test the participant on the application of work, love, and play assessment. In this scenario, the participant will meet a standardized patient in the exam room via a robot to discuss a behavioral health concern. At the end of each session (approximately 2 hours later), self-efficacy will be measured.
Other: Robot
Use of a telesimulation robot using contextual interview format.

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
Changes in Self-Efficacy in Patient Centeredness Questionnaire (SEPCQ27) 27-item
Time Frame: Baseline and approximately 2-hours after baseline
The SEPCQ is designed to measure confidence levels at delivering patient-centered care (A 7-point Likert scale was used with "0" (to a very low degree) and "6" (To a very high degree)
Baseline and approximately 2-hours 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.
Pacific Northwest University of Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Association of Colleges of Osteopathic Medicine - AACOM

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: Lisa Munoz, MPH, Pacific Northwest University of Health Sciences

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.
November 30, 2017

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.
June 30, 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.
September 23, 2020

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).
August 24, 2018

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 5, 2018

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 7, 2018

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.
March 16, 2022

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.
March 15, 2022

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.
March 1, 2022

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.
  • 2017-020

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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