Challenging Situations in Family Centered Rounds: Making the Best out of Worst Case Scenarios

This resource is a workshop intended for both seasoned and novice health care providers who are interested in becoming prepared for challenging scenarios that may be encountered during FCR. Case scenarios of challenging situations relating to discussing sensitive topics, correcting errors, and teaching learners in front of both parents and patients are presented. Tangible opportunities to role model communication skills, efficiency, and teaching skills for trainees are highlighted. The session will conclude with a question and answer session with a multi-specialty panel to share experiences and strategies for addressing the unexpected during FCR. By the end of the workshop, participants will take away concrete strategies that they can share with their home institutions that will enhance the FCR process. AAMC MedEdPORTAL publication ID 9728. Link to original

Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial

Abstract Background Few papers discuss the pragmatics of conducting large, cluster randomized clinical trials. Here we describe the sequential steps taken to develop methods to implement the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) trial that tested the effect of a nurse-implemented, goal-directed, comfort algorithm on clinical outcomes in pediatric patients with acute respiratory failure. Methods After development in a single institution, the RESTORE intervention was pilot-tested in two pediatric intensive care units (PICUs) to evaluate safety and feasibility. After the pilot, the RESTORE intervention was simplified to enhance reproducibility across multiple PICUs. The final RESTORE trial was developed as a cluster randomized clinical trial where the unit of randomization was the PICU, stratified by PICU size, and the unit of inference was the patient. Study execution was revised based on our Data and Safety Monitoring Board’s recommendation to consult with the Department of Health and Human Services’ Office of Human Research Protection (OHRP) on how best to consent eligible subjects. OHRP deemed that the RESTORE intervention posed greater than minimal risk and that all enrolled subjects provide consent reflecting their level of participation. Results Thirty-one PICUs of varying size, organization and academic affiliation participated and over 2800 critically ill infants and children supported on mechanical ventilation for acute pulmonary disease were enrolled. The primary outcome for the trial was the duration of mechanical ventilation; secondary outcomes included time awake and comfortable, total sedative exposure and iatrogenic withdrawal symptoms. Throughout the clinical trial the investigative team worked to maintain treatment fidelity, enrollment milestones and co-investigator enthusiasm. We considered the potential impact of competing clinical trials through a decision-making framework. Conclusions The RESTORE clinical trial was a large and complex multicenter study that has provided the necessary evidence to guide sedation practices in the field of pediatric critical care. Specific issues that were unique to this trial included level of consent, adding clinical sites to augment enrollment and evaluating the potential impact of competing clinical trials. Trial registration ClinicalTrials.gov, Identifiers: Pilot trial: NCT00142766; Retrospectively registerd on 2 September 2005. Cluster randomized trial: NCT00814099. Registered on 23 December 2008