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

• ClinicalTrials.gov Identifier: NCT02191085
• Recruitment Status: Unknown
• First Posted: July 15, 2014
• Last Update Posted: March 31, 2020
• Sponsor: University of Calgary
• Collaborator: The Lung Association
• Information provided by (Responsible Party): Sachin R. Pendharkar, University of Calgary

Tracking Information

• First Submitted Date: July 13, 2014
• First Posted Date: July 15, 2014
• Last Update Posted Date: March 31, 2020
• Actual Study Start Date: October 2014
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2015)

Adherence to positive airway pressure (PAP) therapy [ Time Frame: 3 months after treatment initiation ]

Data includes number of days of PAP use and number of hours used per day.

Original Primary Outcome Measures (submitted: July 13, 2014)

Change in daytime sleepiness [ Time Frame: 3 months after treatment initiation ]

Epworth Sleepiness Scale

Current Secondary Outcome Measures (submitted: December 7, 2015)

• Change in daytime sleepiness [ Time Frame: 3 months after treatment initiation ]
  Epworth Sleepiness Scale
• Health care utilization [ Time Frame: 1 year after treatment initiation ]
  Combination of physician visits, emergency department visits, hospitalizations
• Incremental cost-effectiveness ratio [ Time Frame: 1 year after treatment initiation ]
  Comparing cost/QALY for intervention vs. control arm (QALY determined from Health Utilities Index
• Time from date of referral to date of treatment initiation [ Time Frame: Expected within 1 year (unknown due to nature of outcome) ]
  Comparing cycle times for intervention vs. control arm
• Change in daytime sleepiness [ Time Frame: 1 year after treatment initiation ]
  Epworth Sleepiness Scale
• Adherence to positive airway pressure (PAP) therapy [ Time Frame: 1 year after treatment initiation ]
  Data includes number of days of PAP use and number of hours used per day.
• Change in disease specific health-related quality of life [ Time Frame: 3 months after treatment initiation ]
  Sleep Apnea Quality of Life Index
• Change in disease specific health-related quality of life [ Time Frame: 1 year after treatment initiation ]
  Sleep Apnea Quality of Life Index
• Patient experience [ Time Frame: 3 months after treatment initiation ]
  Visit-Specific Instrument (VSQ-9)
• Patient experience [ Time Frame: 1 year after treatment initiation ]
  Visit-Specific Instrument (VSQ-9)
• Number of sleep diagnostic tests and sleep ambulatory care visits [ Time Frame: 1 year after treatment initiation ]
  Will measure sleep physician and ACP visits as well as polysomnography and ambulatory testing
• Change in severity of sleep-disordered breathing [ Time Frame: 3 months after treatment initiation ]
  Respiratory disturbance index from ambulatory testing
• Change in severity of sleep-disordered breathing [ Time Frame: 1 year after treatment initiation ]
  Respiratory disturbance index from ambulatory testing
• Change in general health-related quality of life [ Time Frame: 3 months after treatment initiation ]
  Health Utilities Index
• Change in general health-related quality of life [ Time Frame: 1 year after treatment initiation ]
  Health Utilities Index

Original Secondary Outcome Measures (submitted: July 13, 2014)

• Change in daytime sleepiness [ Time Frame: 1 year after treatment initiation ]
  Epworth Sleepiness Scale
• Number of sleep physician visits [ Time Frame: 1 year after treatment initiation ]
• Incremental cost-effectiveness ratio [ Time Frame: 1 year after treatment initiation ]
  Comparing cost/QALY for intervention vs. control arm
• Time from date of referral to date of first of provider appointment [ Time Frame: Expected within 1 year (unknown due to nature of outcome) ]
• Adherence to positive airway pressure (PAP) therapy [ Time Frame: 3 months after treatment initiation ]
  Data includes number of days of PAP use and number of hours used per day.
• Adherence to positive airway pressure (PAP) therapy [ Time Frame: 1 year after treatment initiation ]
  Data includes number of days of PAP use and number of hours used per day.
• Change in disease specific health-related quality of life [ Time Frame: 3 months after treatment initiation ]
  Sleep Apnea Quality of Life Index
• Change in disease specific health-related quality of life [ Time Frame: 1 year after treatment initiation ]
  Sleep Apnea Quality of Life Index
• Patient experience [ Time Frame: 3 months after treatment initiation ]
  Consumers Assessments of Healthcare Providers and Systems clinician-group survey
• Patient experience [ Time Frame: 1 year after treatment initiation ]
  Consumers Assessments of Healthcare Providers and Systems clinician-group survey
• Time from date of referral to date of initiation of PAP therapy [ Time Frame: Expected within 1 year (unknown due to nature of outcome) ]
  Comparison to historical data
• Number of sleep diagnostic tests [ Time Frame: 1 year after treatment initiation ]
  Will measure both polysomnography and ambulatory testing
• Change in severity of sleep-disordered breathing [ Time Frame: 3 months after treatment initiation ]
  Respiratory disturbance index from ambulatory testing
• Change in severity of sleep-disordered breathing [ Time Frame: 1 year after treatment initiation ]
  Respiratory disturbance index from ambulatory testing
• Change in general health-related quality of life [ Time Frame: 3 months after treatment initiation ]
  Health Utilities Index
• Change in general health-related quality of life [ Time Frame: 1 year after treatment initiation ]
  Health Utilities Index

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
• Official Title: Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing

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. 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. to determine the effects of non-physician health care provider treatment to patient access;
3. to determine health care utilization and related costs associated with non-physician health care provider treatment.

Detailed Description

The difficulty in providing timely access to sleep specialists is widespread. These delays are particularly important for patients with severe SDB due to the increased risk of adverse clinical outcomes and potential associated healthcare costs. The lack of timely access has sparked an interest in the use of alternate care providers (ACPs) to manage patients with SDB. Our group and others have demonstrated that ACPs are an effective and efficient substitute for physicians for patients with uncomplicated SDB. However, the role of ACPs in the management of patients with severe SDB remains unclear.

Prompted by wait times that far exceed current Canadian guidelines, we have recently implemented an ACP-led "Fast Track" clinic for patients who are referred to the Foothills Medical Centre (FMC) Sleep Centre with suspected severe SDB. In this clinic, patients with suspected severe SDB are assessed by a sleep-trained registered respiratory therapist functioning as an ACP. Decisions regarding further sleep testing and treatment are made by the patient and ACP, under the guidance of a sleep physician. This model of care differs from a physician-led model that is used at the FMC Sleep Centre.

To evaluate this novel care delivery model, we have designed a randomized trial comparing outcomes for patients in the "Fast Track" clinic to those who undergo conventional, physician-led care. The specific goals of this study are:

1. to compare the clinical effectiveness of an ACP-led clinic for patients with suspected severe SDB to physician-led management;
2. to determine whether cycle times from referral to diagnosis and treatment for patients referred with suspected severe SDB can be reduced by an ACP-led clinic;
3. to determine the impact of an ACP-led clinic on the demand for sleep physicians, ACPs and diagnostic testing;
4. to compare the cost-effectiveness of these models of care using data on healthcare utilization, costs, and patient reported health-related quality of life (HRQOL).

Patients in the "Standard Management" arm 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.

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 (e.g. severe hypoxemia, decompensated cardiorespiratory failure, etc.). 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.

As is usual procedure at the FMC Sleep Centre, ambulatory sleep test requisitions will be completed by ACPs or physicians, whereas all polysomnogram requisitions will be completed by the primary sleep physician to ensure adequate blinding of patient assignment. The research associate will ensure that all tests are interpreted in advance of clinic visits. Patients who are followed by ACPs in either arm can be referred to the primary sleep physician for assessment of non-respiratory sleep disorders, or for persistent symptoms such as daytime sleepiness.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider); Primary Purpose: Health Services Research
• Condition: Sleep Disordered Breathing

Intervention

Procedure: Fast Track

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.

Study Arms

• No Intervention: Standard Management
  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.
• Active Comparator: Fast Track
  In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient.
  Intervention: Procedure: Fast Track

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 16, 2016): 164
• Original Estimated Enrollment (submitted: July 13, 2014): 80
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• referred to the FMC Sleep Centre for assessment of SDB

• meet one of the three criteria for suspected severe SDB:

  1. Respiratory disturbance index (RDI) >/= 30 events/hour on an ambulatory sleep test
  2. Mean nocturnal oxygen saturation </= 85% on an ambulatory sleep test
  3. 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
  4. On supplemental oxygen therapy with high suspicion of SDB (as determined by physician review of referral)

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02191085
• Other Study ID Numbers: REB13-1280
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Sachin R. Pendharkar, University of Calgary
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Calgary
• Original Study Sponsor: Same as current
• Collaborators: The Lung Association

Investigators

• Principal Investigator: Sachin R Pendharkar, MD, MSc; University of Calgary

• PRS Account: University of Calgary
• Verification Date: March 2020