The SIM-PLICITY Study: The SIMulation Project - LIstening & Intervention in Pediatric obeSITY

HealthPartners Institute

Status: Completed

Conditions: Childhood Obesity

Treatments: Behavioral: Wait List Control; Behavioral: Educational Intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02946515

R44DP005954 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is looking at the feasibility and efficacy of using SIMmersion's PeopleSim technology to train providers through role playing simulations to effectively conduct discussions with parents to provide intervention for, and reduce the likelihood of progression to childhood obesity.

Full description

The prevalence of childhood obesity has tripled within the last twenty-five years (Skelton et al., 2009). Interventions targeting children are a high priority because children bear the greatest lifetime health risk from overweight and obesity (Ogden et al., 2007; Franks et al., 2010). Health professionals in primary care settings have the potential to reach large numbers of parents and children and address obesity because they have regular interactions with and are influential in the lives of families. Studies show that even brief advice delivered well can have a meaningful impact. To support providers in this important role, the Centers for Disease Control and Prevention collaborated with other health organizations to develop recommendations for assessment, prevention, and treatment of childhood and adolescent overweight and obesity. Despite the 2007 publication of these recommendations and increasing recognition of childhood obesity as a public health problem, rates of provision of obesity-related guidance and counseling remain low (Tanda & Salsberry, 2013), and research indicates that health care providers could use additional education, training, and support related to obesity prevention and treatment. Thus, effective strategies to support pediatric primary care providers in their efforts to intervene against address childhood obesity are needed. Building off the successes achieved in their Phase I study, SIMmersion LLC, in collaboration with Dr. Nancy Sherwood from HealthPartners Institute , Dr. Jayne Fulkerson from the University of Minnesota, and Dr. Michael Fleming from Northwestern University, will expand the Phase I simulation prototype, utilizing feedback provided by a team of independent experts. The innovative computer-based training system with interactive role-play simulations will provide health care providers with much needed experiential opportunities to develop skills in conducting discussions with parents and children about obesity. The product's efficacy will be evaluated in a randomized controlled trial (RCT); 100 pediatric, family practice, and nursing clinicians and trainees at various levels of experience will be recruited to participate. Half of the participants will be randomly assigned to the intervention group during which they will use the newly developed simulation product to develop their skills and half of participants will be randomly assigned to the wait-list control group; the primary outcome is performance in a role play with trained actors at 2 month follow-up.

Enrollment: 44 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21 years of age or older
• A health care provider within the HealthPartners Medical Group system or Park Nicollet clinic system OR a resident in the University of Minnesota pediatrics and family medicine residency program OR a student in the University of Minnesota nursing program or medical school
• Willing and able to participate in measurement visits and intervention activities
• See pediatric patients greater than or equal to 1/3 of their practice time

Exclusion criteria

• < 21 years of age
• Unable to ensure commitment to study measurement and intervention activities
• See pediatric patients less than 1/3 of their practice time

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Educational Intervention

Experimental group

Description:

The educational intervention will be the online simulation training program. Participants will be taught how to use the simulation during a 30 minute orientation session with a research staff person. We will use a mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are 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 will be completed by participants on their own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as needed. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance.

Treatment:

Behavioral: Educational Intervention

Waitlist Control Group

Experimental group

Description:

The control group will participate in pre- and post-test assessments of their conversational skills with a trained actor. At the end of the study, the waitlist control group will be allowed to access to the simulation and the study team will provide training to participants upon request.

Treatment:

Behavioral: Wait List Control