Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing

NCT02191085 | Completed Results

• 1 other identifier: REB13-1280
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

Access to medical care for patients with breathing disorders during sleep is a major problem for Canadians. Recently, there has been increasing interest in how health care providers who are not physicians can help to improve access to medical care for these patients, but it is unclear whether patients with severe sleep-disordered breathing who receive care from these non-physician providers have the same response to treatment as patients who receive care from physicians. Since these severe have a high risk of developing cardiac and respiratory complications and of being hospitalized, an initiative to improve access such as the use of non-physician providers could be of great benefit to individual patients and the health care system. The objectives of this project are:

1. 1.to determine whether patients with severe breathing disorders during sleep have the same response to treatment when cared for by non-physician health care providers (respiratory therapists) as they do when cared for by physicians;
2. 2.to determine the effects of non-physician health care provider treatment to patient access;
3. 3.to determine health care utilization and related costs associated with non-physician health care provider treatment.

Conditions

Sleep Disordered Breathing

Outcome Measures

Primary Outcomes (1)

• Adherence to Positive Airway Pressure (PAP) Therapy

  Data includes number of hours used per night on all nights

  3 months after treatment initiation

Secondary Outcomes (16)

• Change in Daytime Sleepiness

  3 months after treatment initiation

• Health Care Utilization

  1 year after treatment initiation

• Total Healthcare Costs

  1 year after treatment initiation

• Time From Date of Referral to Date of Treatment Initiation

  Expected within 1 year (unknown due to nature of outcome)

• Change in Daytime Sleepiness

  1 year after treatment initiation

Study Arms (2)

Standard Management

NO INTERVENTION

Patients in the "Standard Management" arm will be assessed without any interventions.Patients will be assessed by a sleep respirologist and follow a management plan that is determined by the sleep physician and patient. This plan may involve polysomnography or the initiation of PAP therapy. If further testing is ordered, follow-up may occur with the physician or with an ACP, at the physician's discretion. For patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up to the physician, as the intent of this study is to observe real-world practice and not to change the management of individual patients.

Fast Track

ACTIVE COMPARATOR

In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient.

Procedure: Fast Track

Interventions

Fast Track PROCEDURE

In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the "Fast Track" clinic to assist with the assessment of patients who appear unwell. As in the "Standard Management" arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP.

Fast Track

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred to the FMC Sleep Centre for assessment of SDB
• meet one of the three criteria for suspected severe SDB:
• Respiratory disturbance index (RDI) \>/= 30 events/hour on an ambulatory sleep test
• Mean nocturnal oxygen saturation \</= 85% on an ambulatory sleep test
• Suspected hypoventilation, defined by an RDI \>/= 15 events/hour on an ambulatory sleep test and partial pressure of carbon dioxide \>/= 45 mmHg on arterial blood gas
• On supplemental oxygen therapy with high suspicion of SDB (as determined by physician review of referral)

You may not qualify if:

• Suspected concomitant sleep disorder other than SDB
• A previous diagnosis of OSA treated with PAP or dental appliance
• Primary health insurance provided by a province other than Alberta
• Failure to provide consent to participate in the study
• Under the age of 18

Sponsors & Collaborators

• University of Calgary: lead
• The Lung Association: collaborator

Study Sites (1)

Foothills Medical Centre Sleep Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (12)

• Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7.

  PMID: 15781100 BACKGROUND

• Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.

  PMID: 16282178 BACKGROUND

• Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.

  PMID: 10805822 BACKGROUND

• Flemons WW, Tsai W. Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol. 1997 Feb;99(2):S750-6. doi: 10.1016/s0091-6749(97)70123-4.

  PMID: 9042067 BACKGROUND

• Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.

  PMID: 14505600 BACKGROUND

• Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377.

  PMID: 11502632 BACKGROUND

• Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.

  PMID: 20339144 BACKGROUND

• Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8.

  PMID: 19136368 BACKGROUND

• J Santana M, Jaja O, Duan Q, D Penz E, L Fraser K, J Hanly P, R Pendharkar S. Comparison of patient-reported outcomes between alternative care provider-led and physician-led care for severe sleep disordered breathing: secondary analysis of a randomized clinical trial. J Patient Rep Outcomes. 2024 Sep 26;8(1):107. doi: 10.1186/s41687-024-00747-3.

  PMID: 39325310 DERIVED

• Thornton CS, Tsai WH, Santana MJ, Penz ED, Flemons WW, Fraser KL, Hanly PJ, Pendharkar SR. Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203088. doi: 10.1001/jamanetworkopen.2020.3088.

  PMID: 32310283 DERIVED

• Pendharkar SR, Tsai WH, Penz ED, Santana MJ, Ip-Buting A, Kelly J, Flemons WW, Fraser KL, Hanly PJ. A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing. Ann Am Thorac Soc. 2019 Dec;16(12):1558-1566. doi: 10.1513/AnnalsATS.201901-087OC.

  PMID: 31437008 DERIVED

• Ip-Buting A, Kelly J, Santana MJ, Penz ED, Flemons WW, Tsai WH, Fraser KL, Hanly PJ, Pendharkar SR. Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial. BMJ Open. 2017 Mar 29;7(3):e014012. doi: 10.1136/bmjopen-2016-014012.

  PMID: 28360244 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Dr. Sachin Pendharkar
• Organization: University of Calgary

sachin.pendharkar@ucalgary.ca

403-210-8617

Study Officials

• Sachin R Pendharkar, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 15, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 22, 2025
• Results First Posted: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)