Trial Outcomes & Findings for The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY (NCT NCT02946515)
NCT ID: NCT02946515
Last Updated: 2023-08-23
Results Overview
Change from baseline in simulation total role-play score with a trained actor to evaluate the simulation's efficacy. The role-play scale measured the clinical skills of the participants assessed using standardized patients (SPs), blind to study condition, who acted as parents of a child with overweight during a well-child visit. Immediately following each 15-minute interaction with a study participant, the SP completed a checklist that assessed whether the participant 1) completed the skill correctly, 2) completed the skill incorrectly; or 3) did not complete the skill. Participants received a score of 1 if they completed the skill correctly in both Case A and Case B. The minimum score on the scale is 0 and the maximum score is 60, with higher scores indicating a better outcome.
COMPLETED
NA
44 participants
3 months after baseline
2023-08-23
Participant Flow
Medical and nursing students were recruited from a local university, and pediatric primary care practitioners were recruited through a local health system. All participants were recruited by email and invited to participate. Interested participants were contacted by study team members about the study and an in-person baseline visit was scheduled.
At baseline, participants reviewed and signed the consent form in-person and were given a hard copy for their records. After the baseline measurement visit, participants were randomized to either the intervention group or the wait-list control group. Due to the visit occurring in person, all participants who were consented were randomized (N=44).
Participant milestones
| Measure |
Educational Intervention
The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.
The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor.
|
Waitlist Control Group
The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
20
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Educational Intervention
The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.
The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor.
|
Waitlist Control Group
The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY
Baseline characteristics by cohort
| Measure |
Educational Intervention
n=22 Participants
The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.
The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor.
|
Waitlist Control Group
n=22 Participants
The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after baselineChange from baseline in simulation total role-play score with a trained actor to evaluate the simulation's efficacy. The role-play scale measured the clinical skills of the participants assessed using standardized patients (SPs), blind to study condition, who acted as parents of a child with overweight during a well-child visit. Immediately following each 15-minute interaction with a study participant, the SP completed a checklist that assessed whether the participant 1) completed the skill correctly, 2) completed the skill incorrectly; or 3) did not complete the skill. Participants received a score of 1 if they completed the skill correctly in both Case A and Case B. The minimum score on the scale is 0 and the maximum score is 60, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Educational Intervention
n=22 Participants
The educational intervention was an online simulation training program. Participants were taught how to use the simulation during a brief phone orientation session with a research staff person. A mastery based approach was used, rather than prescribing an absolute number of hours participants need to play. The criteria were as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions were completed by participants on their own. The research team confirmed remote usage and contacted participants by email and phone to prompt usage as needed.
The intervention group participated in pre- and post-test assessments of their conversational skills with a trained actor.
|
Waitlist Control Group
n=22 Participants
The control group participated in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the wait-list control group were allowed to access to the simulation. Access was provided by the study team to all participants in the control group after completion of their post-test assessment.
|
|---|---|---|
|
Simulation Total Role Play Score
Baseline Mean
|
25.73 score on a scale
Standard Deviation 6.27
|
23.73 score on a scale
Standard Deviation 6.71
|
|
Simulation Total Role Play Score
Follow-up Mean
|
33.29 score on a scale
Standard Deviation 4.75
|
25.89 score on a scale
Standard Deviation 4.67
|
Adverse Events
Educational Intervention
Waitlist Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy E. Sherwood, Associate Professor
University of Minnesota - Division of Epidemiology and Community Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place