Reduction of Radial Head Subluxation in Children Via a Nurse Initiated Pathway: A Randomized Control Trial

Study design:

We performed an open (i.e. unblinded) non-inferiority, cluster-randomized control trial, to assess whether emergency department triage nurses could, using a medical directive and given specific training, achieve rates of successful reduction of radial head subluxation that were not substantially lower than those of physicians. The Children's Hospital of Eastern Ontario Research Ethics Board approved this study (REB approval number 08-29X). A cluster randomized trial design was used to facilitate the enrollment of patients. The unpredictable acuity and volume of patients presenting to the emergency department triage area made randomization at a patient level unfeasible. Patients were assigned by day of presentation to either nurse or physician treatment. Each day represents a cluster. The anticipated number of children presenting to the emergency department per day with radial head subluxation was less than one, therefore the reduction of power due to clustering was expected to be inconsequential.

Since this study was an assessment of a practice change (medical directive for nurse initiated reduction of presumed radial head subluxation), written, informed consent was deemed unnecessary by the responsible research ethics board. On nurse initiated reduction days verbal consent for the procedure was obtained from caregivers of eligible children prior to the nurse's attempt at reduction. This consent was recorded on the study case report forms.

Study setting and participants:

All children presenting to the emergency department of the Children's Hospital of Eastern Ontario (CHEO) with a presumed diagnosis of radial head subluxation from October 2009 to October 2010 were screened for enrolment. CHEO is a tertiary care pediatric hospital with approximately 55,000 emergency department visits per year at the time of the study. There are about 60 nurses who work in the emergency department, the majority of whom are trained as triage nurses. All triage nurses have a minimum 2 years of experience, attend a compulsory 4-hour orientation course, and complete three 4-hour shifts alongside an experienced triage nurse. Physician coverage includes 26 full-time physicians with specific training in pediatric emergency medicine and 18 part-time staff physicians with other types of training (including general pediatrics, emergency medicine, and family practice), in addition to pediatric emergency fellows, residents, and medical students working under their supervision. Children were eligible for the study if they met the eligibility criteria for the radial head subluxation medical direction (Appendix 1).