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

Rationale: Lack of timely access to diagnosis and treatment of sleep-disordered breathing (SDB) has sparked interest in using nonphysician providers. Previous studies of these alternative care providers (ACPs) excluded patients with more complicated forms of SDB and did not directly explore 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 noninferiority 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 greater than 30/h, 2) mean nocturnal oxygen saturation less than 85%, and 3) arterial carbon dioxide greater than 45 mm Hg with respiratory event index greater than 15/h. The primary outcome was nightly positive airway pressure adherence at 3 months, using a noninferiority margin of 1 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 with sleep physician care with respect to treatment adherence, because the 95% confidence interval included the noninferiority margin of 1 hour (mean difference, -0.5 [-1.49 to 0.49] h). Patients in the 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.Conclusions: Management of severe SDB using ACPs was indeterminate compared with 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 to improve access to care for patients with severe SDB.Clinical trial registered with www.clinicaltrials.gov (NCT02191085).

Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial.

INTRODUCTION: Despite the high prevalence of sleep-disordered breathing (SDB) and the significant health consequences associated with untreated disease, access to diagnosis and treatment remains a challenge. Even patients with severe SDB (severe obstructive sleep apnoea or hypoventilation), who are at particularly high risk of adverse health effects, are subject to long delays. Previous research has demonstrated that, within a sleep clinic, management by alternative care providers (ACPs) is effective for patients with milder forms of SDB. The purpose of this study is to compare an ACP-led clinic (ACP Clinic) for patients with severe SDB to physician-led care, from the perspective of clinical outcomes, health system efficiency and cost. METHODS AND ANALYSIS: The study is a randomised, controlled, non-inferiority study in which patients who are referred with severe SDB are randomised to management by a sleep physician or by an ACP. ACPs will be supervised by sleep physicians for safety. The primary outcome is positive airway pressure (PAP) adherence after 3 months of therapy. Secondary outcomes include: long-term PAP adherence; clinical response to therapy; health-related quality of life; patient satisfaction; healthcare usage; wait times from referral to treatment initiation and cost-effectiveness. The economic analysis will be performed using the perspective of a publicly funded healthcare system. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Conjoint Health Research Ethics Board (ID: REB13-1280) at the University of Calgary. Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02191085; Pre-results.

An observational study of the effectiveness of alternative care providers in the management of obstructive sleep apnea.

Alternative care providers have been proposed as a substitute for physician-based management of obstructive sleep apnea. The purpose of this study was to describe the clinical course of patients with a new diagnosis of obstructive sleep apnea who were treated with continuous positive airway pressure and followed by alternative care providers at a tertiary care sleep clinic. It was hypothesized that care by alternative care providers would result in improvement of daytime sleepiness and satisfactory treatment adherence, and that a specific number of follow-up visits could be identified after which clinical outcomes no longer improved. The Epworth Sleepiness Scale score was measured for each patient at baseline and at each alternative care provider visit. Patients were discharged when they demonstrated a significant improvement in sleepiness and were adherent to therapy. The Epworth Sleepiness Scale score decreased by 3.9 points from baseline to discharge. Patients with three or more visits required more follow-up time to achieve the same clinical improvement as those with only two visits. Continuous positive airway pressure adherence was comparable to previous studies of physician-led care and improved with ongoing alternative care provider follow-up. The current results suggest that clinical care by alternative care providers leads to continued improvements in sleepiness in patients with obstructive sleep apnea who are treated with continuous positive airway pressure, and that a minority of patients require longer follow-up to achieve a satisfactory clinical response to therapy.

Prevalence of Sleep-disordered Breathing in Obese Patients with Chronic Hypoxemia. A Cross-Sectional Study.

RATIONALE: Hypoxemia in obese patients is likely to be associated with a high prevalence of sleep-disordered breathing. Supplemental oxygen is commonly used to treat chronic hypoxemia but carries some risk in obese individuals due to unrecognized comorbid obstructive sleep apnea (OSA) and obesity hypoventilation syndrome (OHS). OBJECTIVES: The first step in the estimation of this risk is to determine the prevalence of OSA and OHS in obese individuals with chronic, awake hypoxemia. METHODS: A single-center retrospective cohort study was performed to assess the prevalence and severity of OSA and OHS among obese individuals with hypoxemia. One hundred eighty-four individuals underwent arterial blood gas testing and polysomnography. One hundred fifty-eight of these individuals also had spirometry. MEASUREMENTS AND MAIN RESULTS: The prevalence of OSA was 80%, and the prevalence of OHS was 51%. Chronic obstructive pulmonary disease (COPD) was confirmed by spirometry in 49% of the cohort, and OSA was found in 69% of those individuals. The severity of hypoxemia in this cohort was not statistically related to COPD, OSA, or OHS. CONCLUSIONS: OSA and OHS are highly prevalent in obese patients with chronic awake hypoxemia, and OSA frequently coexists with COPD. Evaluation of chronic, awake hypoxemia solely based on arterial blood gas measurements and pulmonary function testing is not sufficient to identify OSA and OHS. Further diagnostic sleep testing should be performed to identify those who could benefit from alternative therapies and to avoid potential harm from treatment with supplemental oxygen alone.