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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02191085
Recruitment Status : Active, not recruiting
First Posted : July 15, 2014
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
The Lung Association
Information provided by (Responsible Party):
Sachin R. Pendharkar, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Procedure: Fast Track Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Evaluation of a "Fast Track" Respiratory Therapy Clinic for Patients With Suspected Severe Sleep-Disordered Breathing
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in daytime sleepiness [ Time Frame: 3 months after treatment initiation ]
    Epworth Sleepiness Scale

  2. Health care utilization [ Time Frame: 1 year after treatment initiation ]
    Combination of physician visits, emergency department visits, hospitalizations

  3. 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

  4. 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

  5. Change in daytime sleepiness [ Time Frame: 1 year after treatment initiation ]
    Epworth Sleepiness Scale

  6. 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.

  7. Change in disease specific health-related quality of life [ Time Frame: 3 months after treatment initiation ]
    Sleep Apnea Quality of Life Index

  8. Change in disease specific health-related quality of life [ Time Frame: 1 year after treatment initiation ]
    Sleep Apnea Quality of Life Index

  9. Patient experience [ Time Frame: 3 months after treatment initiation ]
    Visit-Specific Instrument (VSQ-9)

  10. Patient experience [ Time Frame: 1 year after treatment initiation ]
    Visit-Specific Instrument (VSQ-9)

  11. 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

  12. Change in severity of sleep-disordered breathing [ Time Frame: 3 months after treatment initiation ]
    Respiratory disturbance index from ambulatory testing

  13. Change in severity of sleep-disordered breathing [ Time Frame: 1 year after treatment initiation ]
    Respiratory disturbance index from ambulatory testing

  14. Change in general health-related quality of life [ Time Frame: 3 months after treatment initiation ]
    Health Utilities Index

  15. Change in general health-related quality of life [ Time Frame: 1 year after treatment initiation ]
    Health Utilities Index



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191085


Locations
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Canada, Alberta
Foothills Medical Centre Sleep Centre
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
The Lung Association
Investigators
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Principal Investigator: Sachin R Pendharkar, MD, MSc University of Calgary
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sachin R. Pendharkar, Dr., University of Calgary
ClinicalTrials.gov Identifier: NCT02191085    
Other Study ID Numbers: REB13-1280
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases