Self EfficacyNCT03661372
Telesimulation and Behavioral Health
A study testing Robot and Face-to-face in people with Self Efficacy, run by Pacific Northwest University of Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Self Efficacy
- What is being tested?
- Robot and Face-to-face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2017to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Any enrolled student at a participating program in the Yakima Valley Interprofessional Collaborative
- Age 18-33 (focusing on the Millennial Generation)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Northwest University of Health Sciences
Yakima, Washington, 98901
About this study
Official title: 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.
Read the 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.
- Conditions
- Self Efficacy
- Being tested
- Robot, Face-to-face
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotOther
Use of a telesimulation robot using contextual interview format.
Face-to-faceOther
Use of face-to-face patient interview using contextual interview format.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-Face | Active comparator | 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. Receives: Other: Face-to-face |
| Robot | Active comparator | 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. Receives: Other: Robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Self-Efficacy in Patient Centeredness Questionnaire (SEPCQ27) 27-item
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)
Measured: Baseline and approximately 2-hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Nov 2017
- Primary completion30 Jun 2019
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Northwest University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Colleges of Osteopathic Medicine - AACOM
- Responsible party
- Sponsor
- Investigators
- Lisa Munoz, MPH, Principal investigator, Pacific Northwest University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661372
- Sponsor's protocol ID
- 2017-020
- Status last verified
- Mar 2022
- First submitted
- 24 Aug 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Accreditation Council for Graduate Medical Education (ACGME). (2014, July 1). ACGME program requirements for graduate medical education in family medicine. Retrieved from http://www.acgme.org/acgmeweb/Portals/0/PFAssets/Program Requirements/120_family_medicine_07012014.pdf
Schirmer, J. M., Taylor, D., & Zylstra, R. (2008). New Set of Core Principles of Behavioral Medicine. Society of Teachers of Family Medicine.
Robinson, P. J., Gould, D. A., & Strosahl, K. D. (2010). Real behavior change in primary care: Improving patient outcomes & increasing job satisfaction. Oakland, CA: New Harbinger Publications, Inc.
McCoy CE, Sayegh J, Alrabah R, Yarris LM. Telesimulation: An Innovative Tool for Health Professions Education. AEM Educ Train. 2017 Feb 17;1(2):132-136. doi: 10.1002/aet2.10015. eCollection 2017 Apr.
PubMed 30051023Miller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). New York, NY: The Guilford Press.
Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
PubMed 21768583Rosasco J, Hanson Z, Kramer J, Steele L, Beachy B, Gothard MD, Ahmed R, McCarroll ML. A Randomized Study Using Telepresence Robots for Behavioral Health in Interprofessional Practice and Education. Telemed J E Health. 2021 Jul;27(7):755-762. doi: 10.1089/tmj.2020.0245. Epub 2020 Oct 21.
PubMed 33090088
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03661372
- Acronym / sponsor ID
- 2017-020
- Conditions
- Self Efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Pacific Northwest University of Health SciencesUniversity, hospital or other
- Collaborators
- American Association of Colleges of Osteopathic Medicine - AACOM
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Face-to-Face | Active comparator | Other: Face-to-faceFace-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. |
| Robot | Active comparator | Other: RobotRobot 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. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Any enrolled student at a participating program in the Yakima Valley Interprofessional Collaborative
- Age 18-33 (focusing on the Millennial Generation)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RobotUse of a telesimulation robot using contextual interview format. | Other | Robot |
| Face-to-faceUse of face-to-face patient interview using contextual interview format. | Other | Face-to-Face |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- BackgroundAccreditation Council for Graduate Medical Education (ACGME). (2014, July 1). ACGME program requirements for graduate medical education in family medicine. Retrieved from http://www.acgme.org/acgmeweb/Portals/0/PFAssets/Program Requirements/120_family_medicine_07012014.pdf
- BackgroundSchirmer, J. M., Taylor, D., & Zylstra, R. (2008). New Set of Core Principles of Behavioral Medicine. Society of Teachers of Family Medicine.
- BackgroundRobinson, P. J., Gould, D. A., & Strosahl, K. D. (2010). Real behavior change in primary care: Improving patient outcomes & increasing job satisfaction. Oakland, CA: New Harbinger Publications, Inc.
- Background: PubMed 30051023McCoy CE, Sayegh J, Alrabah R, Yarris LM. Telesimulation: An Innovative Tool for Health Professions Education. AEM Educ Train. 2017 Feb 17;1(2):132-136. doi: 10.1002/aet2.10015. eCollection 2017 Apr.
- BackgroundMiller, W. R., & Rollnick, S. (2002). Motivational interviewing: Preparing people for change (2nd ed.). New York, NY: The Guilford Press.
- Background: PubMed 21768583Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
- Derived from this study: PubMed 33090088Rosasco J, Hanson Z, Kramer J, Steele L, Beachy B, Gothard MD, Ahmed R, McCarroll ML. A Randomized Study Using Telepresence Robots for Behavioral Health in Interprofessional Practice and Education. Telemed J E Health. 2021 Jul;27(7):755-762. doi: 10.1089/tmj.2020.0245. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Munoz, MPH principal investigator
Pacific Northwest University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot and Face-to-face in people with Self Efficacy, run by Pacific Northwest University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Self-Efficacy in Patient Centeredness Questionnaire (SEPCQ27) 27-item (time frame: Baseline and approximately 2-hours after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03661372, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.