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| Name | Class |
|---|---|
| The Lung Association | UNKNOWN |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Management | No Intervention | 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. | |
| Fast Track | Active Comparator | In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Track | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Positive Airway Pressure (PAP) Therapy | Data includes number of hours used per night on all nights | 3 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after treatment initiation |
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Inclusion Criteria:
referred to the FMC Sleep Centre for assessment of SDB
meet one of the three criteria for suspected severe SDB:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sachin R Pendharkar, MD, MSc | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre Sleep Centre | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15781100 | Background | Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53. doi: 10.1016/S0140-6736(05)71141-7. | |
| 16282178 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Reported number reflects those that received intervention as per modified intention to treat design |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Positive Airway Pressure (PAP) Therapy | Data includes number of hours used per night on all nights | Posted | Mean | 95% Confidence Interval | hours per night | 3 months after treatment initiation |
|
Adverse event data were not collected
All-cause mortality, serious and other (not including serious) adverse events were not monitored/assessed.
Since we did not assess or monitor adverse events, we have reported the number at risk as "0" and also the number of patients experiencing an adverse event as "0".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sachin Pendharkar | University of Calgary | 403-210-8617 | sachin.pendharkar@ucalgary.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2017 | Jun 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2017 | Jun 23, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
| Health Care Utilization | Costs for physician visits, emergency department visits, hospitalizations | 1 year after treatment initiation |
| Total Healthcare Costs | Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio) | 1 year after treatment initiation |
| Time From Date of Referral to Date of Treatment Initiation | Comparing cycle times for intervention vs. control arm | Expected within 1 year (unknown due to nature of outcome) |
| 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 | 1 year after treatment initiation |
| Adherence to Positive Airway Pressure (PAP) Therapy | Data includes number of hours used per night. | 1 year after treatment initiation |
| 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 | 3 months after treatment initiation |
| 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 | 1 year after treatment initiation |
| 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. | 3 months after treatment initiation |
| 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. | 1 year after treatment initiation |
| 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 | 1 year after treatment initiation |
| Change in Severity of Sleep-disordered Breathing | Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months | baseline and 3 months after treatment initiation |
| Change in Severity of Sleep-disordered Breathing | Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months | baseline and 1 year after treatment initiation |
| 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 | 3 months after treatment initiation |
| 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 | 1 year after treatment initiation |
| 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 | 1 year after treatment initiation |
| Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104. |
| 10805822 | Background | Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901. |
| 9042067 | Background | Flemons WW, Tsai W. Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol. 1997 Feb;99(2):S750-6. doi: 10.1016/s0091-6749(97)70123-4. |
| 14505600 | Background | Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220. |
| 11502632 | Background | Berg G, Delaive K, Manfreda J, Walld R, Kryger MH. The use of health-care resources in obesity-hypoventilation syndrome. Chest. 2001 Aug;120(2):377-83. doi: 10.1378/chest.120.2.377. |
| 20339144 | Background | Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25. |
| 19136368 | Background | Antic NA, Buchan C, Esterman A, Hensley M, Naughton MT, Rowland S, Williamson B, Windler S, Eckermann S, McEvoy RD. A randomized controlled trial of nurse-led care for symptomatic moderate-severe obstructive sleep apnea. Am J Respir Crit Care Med. 2009 Mar 15;179(6):501-8. doi: 10.1164/rccm.200810-1558OC. Epub 2009 Jan 8. |
| 39325310 | Derived | J Santana M, Jaja O, Duan Q, D Penz E, L Fraser K, J Hanly P, R Pendharkar S. Comparison of patient-reported outcomes between alternative care provider-led and physician-led care for severe sleep disordered breathing: secondary analysis of a randomized clinical trial. J Patient Rep Outcomes. 2024 Sep 26;8(1):107. doi: 10.1186/s41687-024-00747-3. |
| 32310283 | Derived | Thornton CS, Tsai WH, Santana MJ, Penz ED, Flemons WW, Fraser KL, Hanly PJ, Pendharkar SR. Effects of Wait Times on Treatment Adherence and Clinical Outcomes in Patients With Severe Sleep-Disordered Breathing: A Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203088. doi: 10.1001/jamanetworkopen.2020.3088. |
| 31437008 | Derived | Pendharkar SR, Tsai WH, Penz ED, Santana MJ, Ip-Buting A, Kelly J, Flemons WW, Fraser KL, Hanly PJ. A Randomized Controlled Trial of an Alternative Care Provider Clinic for Severe Sleep-disordered Breathing. Ann Am Thorac Soc. 2019 Dec;16(12):1558-1566. doi: 10.1513/AnnalsATS.201901-087OC. |
| 28360244 | Derived | Ip-Buting A, Kelly J, Santana MJ, Penz ED, Flemons WW, Tsai WH, Fraser KL, Hanly PJ, Pendharkar SR. Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial. BMJ Open. 2017 Mar 29;7(3):e014012. doi: 10.1136/bmjopen-2016-014012. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Reported number reflects those that received intervention as per modified intention to treat design | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index, kg/m^2 | Reported number reflects those that received intervention as per modified intention to treat design | Mean | Standard Deviation | kg/m^2 |
|
| Respiratory Event Index, events/h | Respiratory Event Index on level 3 home sleep apnea test, collected at baseline | Reported number reflects those that received intervention as per modified intention to treat design | Mean | Standard Deviation | events/h |
|
| Mean oxygen saturation on home sleep apnea test | Mean oxygen saturation during a level 3 home sleep apnea test, collected at baseline | Reported number reflects those that received intervention as per modified intention to treat design | Mean | Standard Deviation | % oxygen saturation |
|
| Apnea hypopnea index, events/h | Apnea hypopnea index measured using level 1 polysomnography, measured to characterize sleep-disordered breathing in selected patients. Need for polysomnography was determined by the clinical provider at initial assessment. This measurement was not performed at baseline but was not influenced by study allocation and is provided as another baseline measure of sleep-disordered breathing severity. | Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography | Mean | Standard Deviation | events/h |
|
| Mean oxygen saturation on polysomnography | Mean oxygen saturation measured during level 1 polysomnography, measured to characterize sleep-disordered breathing in selected patients. Need for polysomnography was determined by the clinical provider at initial assessment. This measurement was not performed at baseline but was not influenced by study allocation and is provided as another baseline measure of sleep-disordered breathing severity. | Reported number reflects those that received intervention as per modified intention to treat design and who underwent polysomnography | Mean | Standard Deviation | % oxygen saturation |
|
| OG001 |
| 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. |
|
|
| 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 | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months after treatment initiation |
|
|
|
| Secondary | Health Care Utilization | Costs for physician visits, emergency department visits, hospitalizations | Posted | Mean | Standard Deviation | dollars | 1 year after treatment initiation |
|
|
|
| Secondary | Total Healthcare Costs | Comparing costs for each arm (used to calculate the incremental cost effectiveness ratio) | Posted | Mean | Standard Deviation | dollars | 1 year after treatment initiation |
|
|
|
| Secondary | Time From Date of Referral to Date of Treatment Initiation | Comparing cycle times for intervention vs. control arm | Posted | Mean | 95% Confidence Interval | days | Expected within 1 year (unknown due to nature of outcome) |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year after treatment initiation |
|
|
|
| Secondary | Adherence to Positive Airway Pressure (PAP) Therapy | Data includes number of hours used per night. | Posted | Mean | 95% Confidence Interval | hours/night | 1 year after treatment initiation |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after treatment initiation |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year after treatment initiation |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after treatment initiation |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year after treatment initiation |
|
|
|
| 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 | Posted | Mean | Standard Deviation | dollars | 1 year after treatment initiation |
|
|
|
| Secondary | Change in Severity of Sleep-disordered Breathing | Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months | Posted | Mean | 95% Confidence Interval | events/h | baseline and 3 months after treatment initiation |
|
|
|
| Secondary | Change in Severity of Sleep-disordered Breathing | Respiratory event index from ambulatory testing - reported values represent change from baseline to 3 months | Posted | Mean | 95% Confidence Interval | events/h | baseline and 1 year after treatment initiation |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 3 months after treatment initiation |
|
|
|
| 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 | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year after treatment initiation |
|
|
|
| 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 | Posted | Mean | Standard Deviation | quality adjusted life years | 1 year after treatment initiation |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Hospitalization visits |
|
| New clinical visit costs |
|
| Follow-up clinical visits |
|