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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02191085
Enrollment
186
Registered
2014-07-15
Start date
2014-10-31
Completion date
2019-12-31
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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 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.

Interventions

PROCEDUREFast 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.

Sponsors

The Lung Association
CollaboratorUNKNOWN
University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Positive Airway Pressure (PAP) Therapy3 months after treatment initiationData includes number of hours used per night on all nights

Secondary

MeasureTime frameDescription
Health Care Utilization1 year after treatment initiationCosts for physician visits, emergency department visits, hospitalizations
Total Healthcare Costs1 year after treatment initiationComparing costs for each arm (used to calculate the incremental cost effectiveness ratio)
Time From Date of Referral to Date of Treatment InitiationExpected within 1 year (unknown due to nature of outcome)Comparing cycle times for intervention vs. control arm
Adherence to Positive Airway Pressure (PAP) Therapy1 year after treatment initiationData includes number of hours used per night.
Change in Disease Specific Health-related Quality of Life3 months after treatment initiationSleep 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
Change in Daytime Sleepiness3 months after treatment initiationEpworth Sleepiness Scale - this is a subjective scale measuring tendency for an individual to fall asleep in 8 different circumstances. Score is 0-3 for each circumstance but is reported as a total score. Minimum total score = 0, Maximum total score = 24 Higher scores mean worse outcome
Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits1 year after treatment initiationReported as costs for home sleep apnea tests, polysomnograms, new and follow-up clinical visits
Change in Severity of Sleep-disordered Breathingbaseline and 3 months after treatment initiationRespiratory event index from ambulatory testing - reported values represent change from baseline to 3 months
Change in General Health-related Quality of Life3 months after treatment initiationHealth 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 Years1 year after treatment initiationComparing 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
Patient Satisfaction3 months after treatment initiationVisit-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.

Countries

Canada

Participant flow

Participants by arm

ArmCount
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.
92
Fast Track
In the Fast Track arm, an ACP will perform the initial assessment and will determine the management plan with the patient. 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.
94
Total186

Baseline characteristics

CharacteristicStandard ManagementFast TrackTotal
Age, Continuous55 years
STANDARD_DEVIATION 13
54 years
STANDARD_DEVIATION 12
55 years
STANDARD_DEVIATION 12
Apnea hypopnea index, events/h77 events/h
STANDARD_DEVIATION 50
75 events/h
STANDARD_DEVIATION 59
76 events/h
STANDARD_DEVIATION 54
Body mass index, kg/m^239 kg/m^2
STANDARD_DEVIATION 9
40 kg/m^2
STANDARD_DEVIATION 10
39 kg/m^2
STANDARD_DEVIATION 10
Mean oxygen saturation on home sleep apnea test86 % oxygen saturation
STANDARD_DEVIATION 5
85 % oxygen saturation
STANDARD_DEVIATION 5
85 % oxygen saturation
STANDARD_DEVIATION 5
Mean oxygen saturation on polysomnography86 % oxygen saturation
STANDARD_DEVIATION 5
85 % oxygen saturation
STANDARD_DEVIATION 5
85 % oxygen saturation
STANDARD_DEVIATION 5
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
92 participants94 participants186 participants
Respiratory Event Index, events/h55 events/h
STANDARD_DEVIATION 29
51 events/h
STANDARD_DEVIATION 28
53 events/h
STANDARD_DEVIATION 28
Sex: Female, Male
Female
21 Participants23 Participants44 Participants
Sex: Female, Male
Male
54 Participants58 Participants112 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Adherence to Positive Airway Pressure (PAP) Therapy

Data includes number of hours used per night on all nights

Time frame: 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementAdherence to Positive Airway Pressure (PAP) Therapy4 hours per night
Fast TrackAdherence to Positive Airway Pressure (PAP) Therapy3.5 hours per night
Secondary

Adherence to Positive Airway Pressure (PAP) Therapy

Data includes number of hours used per night.

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementAdherence to Positive Airway Pressure (PAP) Therapy5.56 hours/night
Fast TrackAdherence to Positive Airway Pressure (PAP) Therapy6.14 hours/night
Secondary

Change in Daytime Sleepiness

Epworth Sleepiness Scale - this is a subjective scale measuring tendency for an individual to fall asleep in 8 different circumstances. Score is 0-3 for each circumstance but is reported as a total score. Minimum total score = 0, Maximum total score = 24 Higher scores mean worse outcome

Time frame: 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Daytime Sleepiness3.4 score on a scale
Fast TrackChange in Daytime Sleepiness5.4 score on a scale
Secondary

Change in Daytime Sleepiness

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

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Daytime Sleepiness4.62 units on a scale
Fast TrackChange in Daytime Sleepiness1.79 units on a scale
Secondary

Change in Disease Specific Health-related Quality of Life

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

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Disease Specific Health-related Quality of Life0.99 units on a scale
Fast TrackChange in Disease Specific Health-related Quality of Life1.39 units on a scale
Secondary

Change in Disease Specific Health-related Quality of Life

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

Time frame: 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Disease Specific Health-related Quality of Life0.83 units on a scale
Fast TrackChange in Disease Specific Health-related Quality of Life1.2 units on a scale
Secondary

Change in General Health-related Quality of Life

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

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in General Health-related Quality of Life0.15 units on a scale
Fast TrackChange in General Health-related Quality of Life0.15 units on a scale
Secondary

Change in General Health-related Quality of Life

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

Time frame: 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in General Health-related Quality of Life0.06 units on a scale
Fast TrackChange in General Health-related Quality of Life0.15 units on a scale
Secondary

Change in Severity of Sleep-disordered Breathing

Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months

Time frame: baseline and 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Severity of Sleep-disordered Breathing-46 events/h
Fast TrackChange in Severity of Sleep-disordered Breathing-44 events/h
Secondary

Change in Severity of Sleep-disordered Breathing

Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months

Time frame: baseline and 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementChange in Severity of Sleep-disordered Breathing-45 events/h
Fast TrackChange in Severity of Sleep-disordered Breathing-41 events/h
Secondary

Health Care Utilization

Costs for physician visits, emergency department visits, hospitalizations

Time frame: 1 year after treatment initiation

ArmMeasureGroupValue (MEAN)Dispersion
Standard ManagementHealth Care UtilizationPhysician costs1960 dollarsStandard Deviation 2440
Standard ManagementHealth Care UtilizationEmergency Department visits282 dollarsStandard Deviation 831
Standard ManagementHealth Care UtilizationHospitalization visits1410 dollarsStandard Deviation 4410
Fast TrackHealth Care UtilizationPhysician costs1670 dollarsStandard Deviation 2430
Fast TrackHealth Care UtilizationEmergency Department visits219 dollarsStandard Deviation 585
Fast TrackHealth Care UtilizationHospitalization visits1760 dollarsStandard Deviation 5930
Secondary

Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits

Reported as costs for home sleep apnea tests, polysomnograms, new and follow-up clinical visits

Time frame: 1 year after treatment initiation

ArmMeasureGroupValue (MEAN)Dispersion
Standard ManagementNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsHome sleep apnea test costs57.2 dollarsStandard Deviation 21.4
Standard ManagementNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsPolysomnogram costs649 dollarsStandard Deviation 589
Standard ManagementNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsNew clinical visit costs182 dollarsStandard Deviation 0
Standard ManagementNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsFollow-up clinical visits101 dollarsStandard Deviation 119
Fast TrackNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsFollow-up clinical visits77.6 dollarsStandard Deviation 91.3
Fast TrackNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsHome sleep apnea test costs56.2 dollarsStandard Deviation 20.3
Fast TrackNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsNew clinical visit costs56.2 dollarsStandard Deviation 0
Fast TrackNumber of Sleep Diagnostic Tests and Sleep Ambulatory Care VisitsPolysomnogram costs566 dollarsStandard Deviation 637
Secondary

Patient Satisfaction

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.

Time frame: 3 months after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementPatient Satisfaction36 units on a scale
Fast TrackPatient Satisfaction38 units on a scale
Secondary

Patient Satisfaction

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.

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)
Standard ManagementPatient Satisfaction34.54 units on a scale
Fast TrackPatient Satisfaction37.39 units on a scale
Secondary

Quality Adjusted Life Years

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

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)Dispersion
Standard ManagementQuality Adjusted Life Years0.587 quality adjusted life yearsStandard Deviation 0.306
Fast TrackQuality Adjusted Life Years0.654 quality adjusted life yearsStandard Deviation 0.289
Secondary

Time From Date of Referral to Date of Treatment Initiation

Comparing cycle times for intervention vs. control arm

Time frame: Expected within 1 year (unknown due to nature of outcome)

ArmMeasureValue (MEAN)
Standard ManagementTime From Date of Referral to Date of Treatment Initiation134 days
Fast TrackTime From Date of Referral to Date of Treatment Initiation110 days
Secondary

Total Healthcare Costs

Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio)

Time frame: 1 year after treatment initiation

ArmMeasureValue (MEAN)Dispersion
Standard ManagementTotal Healthcare Costs8572 dollarsStandard Deviation 7617
Fast TrackTotal Healthcare Costs8203 dollarsStandard Deviation 8841

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026