Clinical trial NCT02191085: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Disordered Breathing
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Lung Association
First posted: 2014-07-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Adherence to positive airway pressure (PAP) therapy
timeFrame: 3 months after treatment initiation
Secondary outcomes:
measure: Change in daytime sleepiness
timeFrame: 3 months after treatment initiation
measure: Health care utilization
timeFrame: 1 year after treatment initiation
measure: Incremental cost-effectiveness ratio
timeFrame: 1 year after treatment initiation
measure: Time from date of referral to date of treatment initiation
timeFrame: Expected within 1 year (unknown due to nature of outcome)
measure: Change in daytime sleepiness
timeFrame: 1 year after treatment initiation
measure: Adherence to positive airway pressure (PAP) therapy
timeFrame: 1 year after treatment initiation
measure: Change in disease specific health-related quality of life
timeFrame: 3 months after treatment initiation
measure: Change in disease specific health-related quality of life
timeFrame: 1 year after treatment initiation
measure: Patient experience
timeFrame: 3 months after treatment initiation
measure: Patient experience
timeFrame: 1 year after treatment initiation
measure: Number of sleep diagnostic tests and sleep ambulatory care visits
timeFrame: 1 year after treatment initiation
measure: Change in severity of sleep-disordered breathing
timeFrame: 3 months after treatment initiation
measure: Change in severity of sleep-disordered breathing
timeFrame: 1 year after treatment initiation
measure: Change in general health-related quality of life
timeFrame: 3 months after treatment initiation
measure: Change in general health-related quality of life
timeFrame: 1 year after treatment initiation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre Sleep Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sachin R Pendharkar, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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