A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing

Abstract

Rationale: Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using non-physician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and have not directly explored the impacts of a model incorporating ACPs on healthcare system performance, such as wait times. Objectives: To evaluate the use of ACPs in the management of patients with severe SDB from a clinical and system perspective. Methods: In this non-inferiority study, patients with severe SDB (n=156) were enrolled from October 2014 to July 2016 and randomized to either sleep physician management or management by ACP with same-day sleep physician review. Severe SDB was defined as one of: (1) respiratory event index (REI) >30/hr; (2) mean nocturnal oxygen saturation 45mmHg with REI >15/hr. The primary outcome was nightly positive airway pressure adherence at three months, using a non-inferiority margin of one hour. Secondary outcomes included: sleepiness; quality of life; patient satisfaction; wait times for diagnosis and treatment initiation; and demand for further testing and clinical assessment. Outcomes were evaluated using modified intention to treat and per protocol analyses. Results: Care delivery using ACPs was indeterminate compared to sleep physician care with respect to treatment adherence since the 95% confidence interval included the non-inferiority margin of one hour (mean difference -0.5 (-1.49,0.49) hours). Patients in ACP arm reported greater improvements in sleepiness and quality of life; wait times were shorter for initial assessment (28%) and treatment initiation (18%). There was no difference in demand for sleep testing or clinical follow-up. Per protocol analysis revealed similar results. Conclusion: Management of severe SDB using ACPs was indeterminate compared to sleep physician care. The small decrease in adherence in the ACP arm was balanced by benefits in patient reported outcomes and reduction in wait times. In systems with unacceptably long wait times for SDB diagnosis and treatment, a small decrease in treatment adherence as was observed in this study may be an acceptable trade-off in order to improve access to care for patients with severe SDB. Clinical trial registered ClinicalTrials.gov (NCT02191085)