<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02191085</url>
  </required_header>
  <id_info>
    <org_study_id>REB13-1280</org_study_id>
    <nct_id>NCT02191085</nct_id>
  </id_info>
  <brief_title>Evaluation of a &quot;Fast Track&quot; Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing</brief_title>
  <official_title>Evaluation of a &quot;Fast Track&quot; Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Lung Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Access to medical care for patients with breathing disorders during sleep is a major problem&#xD;
      for Canadians. Recently, there has been increasing interest in how health care providers who&#xD;
      are not physicians can help to improve access to medical care for these patients, but it is&#xD;
      unclear whether patients with severe sleep-disordered breathing who receive care from these&#xD;
      non-physician providers have the same response to treatment as patients who receive care from&#xD;
      physicians. Since these severe have a high risk of developing cardiac and respiratory&#xD;
      complications and of being hospitalized, an initiative to improve access such as the use of&#xD;
      non-physician providers could be of great benefit to individual patients and the health care&#xD;
      system.&#xD;
&#xD;
      The objectives of this project are:&#xD;
&#xD;
        1. to determine whether patients with severe breathing disorders during sleep have the same&#xD;
           response to treatment when cared for by non-physician health care providers (respiratory&#xD;
           therapists) as they do when cared for by physicians;&#xD;
&#xD;
        2. to determine the effects of non-physician health care provider treatment to patient&#xD;
           access;&#xD;
&#xD;
        3. to determine health care utilization and related costs associated with non-physician&#xD;
           health care provider treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The difficulty in providing timely access to sleep specialists is widespread. These delays&#xD;
      are particularly important for patients with severe SDB due to the increased risk of adverse&#xD;
      clinical outcomes and potential associated healthcare costs. The lack of timely access has&#xD;
      sparked an interest in the use of alternate care providers (ACPs) to manage patients with&#xD;
      SDB. Our group and others have demonstrated that ACPs are an effective and efficient&#xD;
      substitute for physicians for patients with uncomplicated SDB. However, the role of ACPs in&#xD;
      the management of patients with severe SDB remains unclear.&#xD;
&#xD;
      Prompted by wait times that far exceed current Canadian guidelines, we have recently&#xD;
      implemented an ACP-led &quot;Fast Track&quot; clinic for patients who are referred to the Foothills&#xD;
      Medical Centre (FMC) Sleep Centre with suspected severe SDB. In this clinic, patients with&#xD;
      suspected severe SDB are assessed by a sleep-trained registered respiratory therapist&#xD;
      functioning as an ACP. Decisions regarding further sleep testing and treatment are made by&#xD;
      the patient and ACP, under the guidance of a sleep physician. This model of care differs from&#xD;
      a physician-led model that is used at the FMC Sleep Centre.&#xD;
&#xD;
      To evaluate this novel care delivery model, we have designed a randomized trial comparing&#xD;
      outcomes for patients in the &quot;Fast Track&quot; clinic to those who undergo conventional,&#xD;
      physician-led care. The specific goals of this study are:&#xD;
&#xD;
        1. to compare the clinical effectiveness of an ACP-led clinic for patients with suspected&#xD;
           severe SDB to physician-led management;&#xD;
&#xD;
        2. to determine whether cycle times from referral to diagnosis and treatment for patients&#xD;
           referred with suspected severe SDB can be reduced by an ACP-led clinic;&#xD;
&#xD;
        3. to determine the impact of an ACP-led clinic on the demand for sleep physicians, ACPs&#xD;
           and diagnostic testing;&#xD;
&#xD;
        4. to compare the cost-effectiveness of these models of care using data on healthcare&#xD;
           utilization, costs, and patient reported health-related quality of life (HRQOL).&#xD;
&#xD;
      Patients in the &quot;Standard Management&quot; arm will be assessed by a sleep respirologist and&#xD;
      follow a management plan that is determined by the sleep physician and patient. This plan may&#xD;
      involve polysomnography or the initiation of PAP therapy. If further testing is ordered,&#xD;
      follow-up may occur with the physician or with an ACP, at the physician's discretion. For&#xD;
      patients initiating PAP therapy, the decision to delegate follow-up to an ACP will be left up&#xD;
      to the physician, as the intent of this study is to observe real-world practice and not to&#xD;
      change the management of individual patients.&#xD;
&#xD;
      In the &quot;Fast Track&quot; arm, an ACP will perform the initial assessment and will determine the&#xD;
      management plan with the patient. To ensure patient safety, the management plan will be&#xD;
      discussed with a sleep respirologist, who will be designated as the patient's primary sleep&#xD;
      physician. This sleep physician will be available at the FMC Sleep Centre during the &quot;Fast&#xD;
      Track&quot; clinic to assist with the assessment of patients who appear unwell (e.g. severe&#xD;
      hypoxemia, decompensated cardiorespiratory failure, etc.). As in the &quot;Standard Management&quot;&#xD;
      arm, follow-up visits to review test results, discuss and initiate treatment, or to assess&#xD;
      treatment response may occur with the ACP who performed the initial assessment or may be&#xD;
      delegated to any other ACP.&#xD;
&#xD;
      As is usual procedure at the FMC Sleep Centre, ambulatory sleep test requisitions will be&#xD;
      completed by ACPs or physicians, whereas all polysomnogram requisitions will be completed by&#xD;
      the primary sleep physician to ensure adequate blinding of patient assignment. The research&#xD;
      associate will ensure that all tests are interpreted in advance of clinic visits. Patients&#xD;
      who are followed by ACPs in either arm can be referred to the primary sleep physician for&#xD;
      assessment of non-respiratory sleep disorders, or for persistent symptoms such as daytime&#xD;
      sleepiness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to positive airway pressure (PAP) therapy</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Data includes number of days of PAP use and number of hours used per day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in daytime sleepiness</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Combination of physician visits, emergency department visits, hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incremental cost-effectiveness ratio</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Comparing cost/QALY for intervention vs. control arm (QALY determined from Health Utilities Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from date of referral to date of treatment initiation</measure>
    <time_frame>Expected within 1 year (unknown due to nature of outcome)</time_frame>
    <description>Comparing cycle times for intervention vs. control arm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in daytime sleepiness</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Epworth Sleepiness Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to positive airway pressure (PAP) therapy</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Data includes number of days of PAP use and number of hours used per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease specific health-related quality of life</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Sleep Apnea Quality of Life Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease specific health-related quality of life</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Sleep Apnea Quality of Life Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Visit-Specific Instrument (VSQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient experience</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Visit-Specific Instrument (VSQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sleep diagnostic tests and sleep ambulatory care visits</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Will measure sleep physician and ACP visits as well as polysomnography and ambulatory testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity of sleep-disordered breathing</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Respiratory disturbance index from ambulatory testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in severity of sleep-disordered breathing</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Respiratory disturbance index from ambulatory testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general health-related quality of life</measure>
    <time_frame>3 months after treatment initiation</time_frame>
    <description>Health Utilities Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in general health-related quality of life</measure>
    <time_frame>1 year after treatment initiation</time_frame>
    <description>Health Utilities Index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">164</enrollment>
  <condition>Sleep Disordered Breathing</condition>
  <arm_group>
    <arm_group_label>Standard Management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the &quot;Standard Management&quot; 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fast Track</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the &quot;Fast Track&quot; arm, an ACP will perform the initial assessment and will determine the management plan with the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast Track</intervention_name>
    <description>In the &quot;Fast Track&quot; 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 &quot;Fast Track&quot; clinic to assist with the assessment of patients who appear unwell. As in the &quot;Standard Management&quot; 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.</description>
    <arm_group_label>Fast Track</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  referred to the FMC Sleep Centre for assessment of SDB&#xD;
&#xD;
          -  meet one of the three criteria for suspected severe SDB:&#xD;
&#xD;
               1. Respiratory disturbance index (RDI) &gt;/= 30 events/hour on an ambulatory sleep&#xD;
                  test&#xD;
&#xD;
               2. Mean nocturnal oxygen saturation &lt;/= 85% on an ambulatory sleep test&#xD;
&#xD;
               3. Suspected hypoventilation, defined by an RDI &gt;/= 15 events/hour on an ambulatory&#xD;
                  sleep test and partial pressure of carbon dioxide &gt;/= 45 mmHg on arterial blood&#xD;
                  gas&#xD;
&#xD;
               4. On supplemental oxygen therapy with high suspicion of SDB (as determined by&#xD;
                  physician review of referral)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected concomitant sleep disorder other than SDB&#xD;
&#xD;
          -  A previous diagnosis of OSA treated with PAP or dental appliance&#xD;
&#xD;
          -  Primary health insurance provided by a province other than Alberta&#xD;
&#xD;
          -  Failure to provide consent to participate in the study&#xD;
&#xD;
          -  Under the age of 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sachin R Pendharkar, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Centre Sleep Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>15781100</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16282178</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10805822</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9042067</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>14505600</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11502632</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20339144</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19136368</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Calgary</investigator_affiliation>
    <investigator_full_name>Sachin R. Pendharkar</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191085
org study id: REB13-1280
nct id: NCT02191085
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Care Provider)
measure: Adherence to positive airway pressure (PAP) therapy
time frame: 3 months after treatment initiation
description: Data includes number of days of PAP use and number of hours used per day.
measure: Change in daytime sleepiness
time frame: 3 months after treatment initiation
description: Epworth Sleepiness Scale
measure: Health care utilization
time frame: 1 year after treatment initiation
description: Combination of physician visits, emergency department visits, hospitalizations
measure: Incremental cost-effectiveness ratio
time frame: 1 year after treatment initiation
description: Comparing cost/QALY for intervention vs. control arm (QALY determined from Health Utilities Index
measure: Time from date of referral to date of treatment initiation
time frame: Expected within 1 year (unknown due to nature of outcome)
description: Comparing cycle times for intervention vs. control arm
measure: Change in daytime sleepiness
time frame: 1 year after treatment initiation
description: Epworth Sleepiness Scale
measure: Adherence to positive airway pressure (PAP) therapy
time frame: 1 year after treatment initiation
description: Data includes number of days of PAP use and number of hours used per day.
measure: Change in disease specific health-related quality of life
time frame: 3 months after treatment initiation
description: Sleep Apnea Quality of Life Index
measure: Change in disease specific health-related quality of life
time frame: 1 year after treatment initiation
description: Sleep Apnea Quality of Life Index
measure: Patient experience
time frame: 3 months after treatment initiation
description: Visit-Specific Instrument (VSQ-9)
measure: Patient experience
time frame: 1 year after treatment initiation
description: Visit-Specific Instrument (VSQ-9)
measure: Number of sleep diagnostic tests and sleep ambulatory care visits
time frame: 1 year after treatment initiation
description: Will measure sleep physician and ACP visits as well as polysomnography and ambulatory testing
measure: Change in severity of sleep-disordered breathing
time frame: 3 months after treatment initiation
description: Respiratory disturbance index from ambulatory testing
measure: Change in severity of sleep-disordered breathing
time frame: 1 year after treatment initiation
description: Respiratory disturbance index from ambulatory testing
measure: Change in general health-related quality of life
time frame: 3 months after treatment initiation
description: Health Utilities Index
measure: Change in general health-related quality of life
time frame: 1 year after treatment initiation
description: Health Utilities Index
arm group label: Standard Management
arm group type: No Intervention
description: 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.
arm group label: Fast Track
arm group type: Active Comparator
description: In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient.
intervention type: Procedure
intervention name: Fast Track
description: 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.
arm group label: Fast Track
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sachin R Pendharkar, MD, MSc
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: University of Calgary
investigator full name: Sachin R. Pendharkar
investigator title: Dr.
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
sharing ipd: Undecided