Sleep Disordered Breathing
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Positive Airway Pressure (PAP) Therapy | 3 months after treatment initiation | Data includes number of hours used per night on all nights |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months 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 |
| Change in Daytime Sleepiness | 3 months after treatment initiation | 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 |
| 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 3 months 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 | 3 months 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 |
| Patient Satisfaction | 3 months 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 186 |
Baseline characteristics
| Characteristic | Standard Management | Fast Track | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 13 | 54 years STANDARD_DEVIATION 12 | 55 years STANDARD_DEVIATION 12 |
| Apnea hypopnea index, events/h | 77 events/h STANDARD_DEVIATION 50 | 75 events/h STANDARD_DEVIATION 59 | 76 events/h STANDARD_DEVIATION 54 |
| Body mass index, kg/m^2 | 39 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 test | 86 % oxygen saturation STANDARD_DEVIATION 5 | 85 % oxygen saturation STANDARD_DEVIATION 5 | 85 % oxygen saturation STANDARD_DEVIATION 5 |
| Mean oxygen saturation on polysomnography | 86 % oxygen saturation STANDARD_DEVIATION 5 | 85 % oxygen saturation STANDARD_DEVIATION 5 | 85 % oxygen saturation STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 92 participants | 94 participants | 186 participants |
| Respiratory Event Index, events/h | 55 events/h STANDARD_DEVIATION 29 | 51 events/h STANDARD_DEVIATION 28 | 53 events/h STANDARD_DEVIATION 28 |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 44 Participants |
| Sex: Female, Male Male | 54 Participants | 58 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Adherence to Positive Airway Pressure (PAP) Therapy | 4 hours per night |
| Fast Track | Adherence to Positive Airway Pressure (PAP) Therapy | 3.5 hours per night |
Adherence to Positive Airway Pressure (PAP) Therapy
Data includes number of hours used per night.
Time frame: 1 year after treatment initiation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Adherence to Positive Airway Pressure (PAP) Therapy | 5.56 hours/night |
| Fast Track | Adherence to Positive Airway Pressure (PAP) Therapy | 6.14 hours/night |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Daytime Sleepiness | 3.4 score on a scale |
| Fast Track | Change in Daytime Sleepiness | 5.4 score on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Daytime Sleepiness | 4.62 units on a scale |
| Fast Track | Change in Daytime Sleepiness | 1.79 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Disease Specific Health-related Quality of Life | 0.99 units on a scale |
| Fast Track | Change in Disease Specific Health-related Quality of Life | 1.39 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Disease Specific Health-related Quality of Life | 0.83 units on a scale |
| Fast Track | Change in Disease Specific Health-related Quality of Life | 1.2 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in General Health-related Quality of Life | 0.15 units on a scale |
| Fast Track | Change in General Health-related Quality of Life | 0.15 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in General Health-related Quality of Life | 0.06 units on a scale |
| Fast Track | Change in General Health-related Quality of Life | 0.15 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Severity of Sleep-disordered Breathing | -46 events/h |
| Fast Track | Change in Severity of Sleep-disordered Breathing | -44 events/h |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Change in Severity of Sleep-disordered Breathing | -45 events/h |
| Fast Track | Change in Severity of Sleep-disordered Breathing | -41 events/h |
Health Care Utilization
Costs for physician visits, emergency department visits, hospitalizations
Time frame: 1 year after treatment initiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Management | Health Care Utilization | Physician costs | 1960 dollars | Standard Deviation 2440 |
| Standard Management | Health Care Utilization | Emergency Department visits | 282 dollars | Standard Deviation 831 |
| Standard Management | Health Care Utilization | Hospitalization visits | 1410 dollars | Standard Deviation 4410 |
| Fast Track | Health Care Utilization | Physician costs | 1670 dollars | Standard Deviation 2430 |
| Fast Track | Health Care Utilization | Emergency Department visits | 219 dollars | Standard Deviation 585 |
| Fast Track | Health Care Utilization | Hospitalization visits | 1760 dollars | Standard Deviation 5930 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Management | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Home sleep apnea test costs | 57.2 dollars | Standard Deviation 21.4 |
| Standard Management | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Polysomnogram costs | 649 dollars | Standard Deviation 589 |
| Standard Management | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | New clinical visit costs | 182 dollars | Standard Deviation 0 |
| Standard Management | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Follow-up clinical visits | 101 dollars | Standard Deviation 119 |
| Fast Track | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Follow-up clinical visits | 77.6 dollars | Standard Deviation 91.3 |
| Fast Track | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Home sleep apnea test costs | 56.2 dollars | Standard Deviation 20.3 |
| Fast Track | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | New clinical visit costs | 56.2 dollars | Standard Deviation 0 |
| Fast Track | Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits | Polysomnogram costs | 566 dollars | Standard Deviation 637 |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Patient Satisfaction | 36 units on a scale |
| Fast Track | Patient Satisfaction | 38 units on a scale |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Patient Satisfaction | 34.54 units on a scale |
| Fast Track | Patient Satisfaction | 37.39 units on a scale |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Management | Quality Adjusted Life Years | 0.587 quality adjusted life years | Standard Deviation 0.306 |
| Fast Track | Quality Adjusted Life Years | 0.654 quality adjusted life years | Standard Deviation 0.289 |
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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Management | Time From Date of Referral to Date of Treatment Initiation | 134 days |
| Fast Track | Time From Date of Referral to Date of Treatment Initiation | 110 days |
Total Healthcare Costs
Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio)
Time frame: 1 year after treatment initiation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Management | Total Healthcare Costs | 8572 dollars | Standard Deviation 7617 |
| Fast Track | Total Healthcare Costs | 8203 dollars | Standard Deviation 8841 |