Composition of the coordinating centre and trial steering committee {5d}
RECRUITMENT
This study does not have a coordinating centre or trial steering committee. Dr. Baron and Dr. Duffecy (co-PIs) are jointly responsible for the conduct of the study. Dr. Baron is the contact PI and is responsible for the day-to-day study operations, overseeing the local study staff who are conducting recruiting and data collection activities and responsible for communications with NIH. Dr. Duffecy is responsible for the coaching component of the study, including overseeing the training of the study coach and conducting fidelity assessments of the intervention and control groups. The executive team will meet monthly and is led by Dr. Baron and includes Dr. Duffecy and the co-PIs as well as the project coordinator and staff. The study operations team, including Drs. Baron, Duffecy, the biostatistician (Dr. Allen), study coordinator, and research assistant, will meet weekly to review the study progress and proactively address any potential issues or slowdowns. The data management team (led by Randy Madsen) consists of the University of Utah Biomedical Informatics Core (BMIC), the statistician (Dr. Allen), and co-I/senior statistician, Dr. Greene. This team provides administration and technical staff to support the development of case report forms in REDCap, as well as automated prompt, reminders, randomization modules, and overseeing blinding in the study database. The recruitment and data collection will be conducted by the study coordinator and research assistant. Their day-to-day activities will be supervised by Dr. Baron, who is on site at the research office. There is not a formal stakeholder and public involvement group in this trial.