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

Not Applicable

Completed

Conditions: Sleep Disordered Breathing

Registration Number: NCT02191085

Lead Sponsor: 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.

Detailed Description: The difficulty in providing timely access to sleep specialists is widespread. These delays are particularly important for patients with severe sleep-disordered breathing (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 positive airway pressure (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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 186

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adherence to Positive Airway Pressure (PAP) Therapy	3 months after treatment initiation	Data includes number of hours used per night on all nights

Secondary Outcome Measures

Name	Time	Method
Change in Daytime Sleepiness	1 year after treatment initiation	Epworth Sleepiness Scale - a subjective scale measuring tendency for an individual to fall asleep in 8 different circumstances. Total score is sum of score in each circumstance (0-3) Minimum total score = 0, Maximum total score = 24 Higher scores mean worse outcome
Health Care Utilization	1 year after treatment initiation	Costs for physician visits, emergency department visits, hospitalizations
Total Healthcare Costs	1 year after treatment initiation	Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio)
Time From Date of Referral to Date of Treatment Initiation	Expected within 1 year (unknown due to nature of outcome)	Comparing cycle times for intervention vs. control arm
Adherence to Positive Airway Pressure (PAP) Therapy	1 year after treatment initiation	Data includes number of hours used per night.
Change in Disease Specific Health-related Quality of Life	1 year after treatment initiation	Sleep Apnea Quality of Life Index - subjective disease-specific quality of life scale, incorporating 4 domains measured pre/post intervention (scored 1-7 on a Likert scale) and 3 post-intervention domains that are weighted before incorporated in the final score Minimum = 1 Maximum = 7 Higher scores indicate a better outcome
Patient Satisfaction	1 year after treatment initiation	Visit-Specific Instrument (VSQ-9) - comprises 9 questions for which patients assign a Likert scale score from 0-5. Score is reported as sum of Likert scale score for each question 0 to 45 scale Higher scores mean a better outcome.
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits	1 year after treatment initiation	Reported as costs for home sleep apnea tests, polysomnograms, new and follow-up clinical visits
Change in Severity of Sleep-disordered Breathing	baseline and 1 year after treatment initiation	Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months
Change in General Health-related Quality of Life	1 year after treatment initiation	Health Utilities Index - a 17-question general health related quality of life index. Total score indicates subjective assessment of HRQOL from close to death to perfect health Maximum = 1 Minimum = 0 Higher score means a better outcome
Quality Adjusted Life Years	1 year after treatment initiation	Comparing quality adjusted life years for each arm (used to calculate the incremental cost effectiveness ratio). Quality adjusted life years were estimated using a utility score ranging from 0 (death) to 1.0 (perfect health) derived from the HUI3 questionnaire, combined with the total length of follow-up time for each patient at baseline 12 months