Study Population and Setting The Working Together Project Elaine S. Belansky, PhD Associate Professor Colorado School of Public Health Pragmatic TRIALS WWW.Ucdenver.edu/implementation  

Overview: WTP is a middle school program designed to put in place evidence-based school level programs, curricula, and environmental features known to support adolescent health. We do this by training middle school teachers to lead students through our AIM process: Assess, Identify, Make it Happen. Students learn to be program planners and implementers by assessing health issues facing students in their school, identifying root causes for those problems, and choosing a few changes to put in place in the school that have been researched and shown to address the root causes and health problem. For example in one school: A: Poor mental health I: Students don’t know how to talk about how they are feeling; Students think they are the only one struggling M: Make academic tutoring available, institute classroom physical activity breaks Balas E, Boren S. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT (eds). Section 1: health and clinical management. In Yearbook of Medical Informatics: Patient Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft; 2000:65-70. WWW.Ucdenver.edu/implementation  

Setting: Where is the trial being done? San Luis Valley (SLV) What criteria did you use to select sites for your study? Must be a middle school located in SLV How does the setting selection for your study influence the research design and generalizability of your findings? Schools didn’t want to be randomized in early/late trial so a quasie-experimental design with time series data was needed Did and if so how did your site selection process differ from one that you would use in a traditional (non pragmatic) trial? No random selection or assignment WWW.Ucdenver.edu/implementation  

Organization: What expertise and resources are needed? What level of expertise was required for the delivery of the interventions? Who delivered the intervention? Teachers delivered curriculum after being trained on it What type of resources were required for the delivery and implementation of the intervention in your study? We provided training, weekly TA, data reports, root cause analyses, and lists of best practices How did these requirements influence the generalizability of your findings? We can only talk about the effectiveness of WTP when a university partner provides schools with significant support WWW.Ucdenver.edu/implementation  

Eligibility: Who is selected to participate? What criteria did you use to select participants for your study? We had no say in which teachers were selected to teach the curriculum or which students participated How did this criteria influence the research design and generalizability of your findings? There was no negative effect for generalizability but because some teachers were weaker than others, we had to test curriculum effectiveness under less than ideal circumstances Did and if so how did your participant selection process differ from one that you would use in a traditional (non pragmatic) trial? There was no random selection or assignment WWW.Ucdenver.edu/implementation  

Recruitment: How are participants recruited? What type of recruitment approach did you use in your study? Schools are recruited via telephone, email, in person contacts Sometimes we used the help of our community-based steering committee Schools look at a “one-pager” and sign an MOU Did this and if so how did this differ from an approach used in traditional (non pragmatic) Same approach although sometimes we don’t have as many relationships with schools trials? WWW.Ucdenver.edu/implementation  

Lessons Learned Be flexible about your research design; it may not match community needs or community’s reality Don’t go pragmatic until you’ve first gone explanatory WWW.Ucdenver.edu/implementation  

References Balas E, Boren S. Managing clinical knowledge for health care improvement. In: Bemmel J, McCray AT (eds). Section 1: health and clinical management. In Yearbook of Medical Informatics: Patient Centered Systems. Stuttgart, Germany: Schattauer Verlagsgesellschaft; 2000:65-70. www.ucdenver.edu/rmprc Click on Working Together Project to see the “one pager”. WWW.Ucdenver.edu/implementation