title: Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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 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.
  
  
  
  NCT02191085; Pre-results.
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Ada
authors.initials: A
authors.lastname: Ip-Buting
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Jenny
authors.initials: J
authors.lastname: Kelly
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Maria J
authors.initials: MJ
authors.lastname: Santana
authors.affiliation: College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
authors.forename: Erika D
authors.initials: ED
authors.lastname: Penz
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: W Ward
authors.initials: WW
authors.lastname: Flemons
authors.affiliation: Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Willis H
authors.initials: WH
authors.lastname: Tsai
authors.affiliation: Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Kristin L
authors.initials: KL
authors.lastname: Fraser
authors.affiliation: Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Hanly
authors.affiliation: W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.|Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada.
authors.forename: Sachin R
authors.initials: SR
authors.lastname: Pendharkar
mesh_terms: D000529:Complementary Therapies / Q000191:economics / Q000379:methods*; D045422:Continuous Positive Airway Pressure / Q000379:methods; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D033181:Information Dissemination; D008297:Male; D010349:Patient Compliance; D017060:Patient Satisfaction; D011175:Positive-Pressure Respiration / Q000379:methods; D015272:Pulmonary Medicine / Q000706:statistics & numerical data; D011788:Quality of Life; D018401:Sample Size; D012891:Sleep Apnea Syndromes / Q000191:economics / Q000628:therapy*; D016896:Treatment Outcome; D014850:Waiting Lists
keywords: SLEEP MEDICINE