You are here

  • Home
  • Archive
  • Volume 7, Issue 3
  • Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial

Article Text

Article menu

Download PDFPDF

XML
Respiratory medicine
Protocol
Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial
  1. Ada Ip-Buting1,
  2. Jenny Kelly1,
  3. Maria J Santana1,2,
  4. Erika D Penz3,
  5. W Ward Flemons1,4,5,
  6. Willis H Tsai2,4,5,
  7. Kristin L Fraser4,5,
  8. Patrick J Hanly4,5,
  9. Sachin R Pendharkar1,2,4,5
  1. 1W21C Research and Innovation Centre, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  2. 2Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  3. 3College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
  4. 4Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
  5. 5Foothills Medical Centre Sleep Centre, University of Calgary, Calgary, Alberta, Canada
  1. Correspondence to Dr Sachin R Pendharkar; Sachin.pendharkar{at}ucalgary.ca

Abstract

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.

  • SLEEP MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-014012

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Footnotes

    • Contributors MJS, EDP, WWF, WHT, KLF, PJH contributed to study conception/design. EDP, WHT, SRP provided statistical expertise, sample size calculation and will lead the analysis. AI-B and JK contributed to data acquisition and drafted this protocol manuscript. All authors revised the paper and approved the final version.

    • Funding This work was supported by The Lung Association—Alberta & NWT and by the Canadian Sleep and Circadian Network (funded by the Canadian Institutes of Health Research, grant number 339739-CDP).

    • Disclaimer The funding source had no role or input in the design of this study and will not have any role or input during its execution, analyses and interpretation of the data, or in the dissemination of the findings.

    • Competing interests None declared.

    • Ethics approval Ethics approval was obtained for this study from the Conjoint Health Research Ethics Board (CHREB) at the University of Calgary (Ethics ID: REB13-1280).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement Study data is not yet available.