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

Sleep Disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02191085
• Other study ID #: REB13-1280
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2020

Study information

• Verified date: March 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 164
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre Sleep Centre	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	The Lung Association

Country where clinical trial is conducted

Canada, 

References & Publications (8)

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. — View Citation

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. — View Citation

Flemons WW, Tsai W. Quality of life consequences of sleep-disordered breathing. J Allergy Clin Immunol. 1997 Feb;99(2):S750-6. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to positive airway pressure (PAP) therapy	Data includes number of days of PAP use and number of hours used per day.	3 months after treatment initiation
Secondary	Change in daytime sleepiness	Epworth Sleepiness Scale	3 months after treatment initiation
Secondary	Health care utilization	Combination of physician visits, emergency department visits, hospitalizations	1 year after treatment initiation
Secondary	Incremental cost-effectiveness ratio	Comparing cost/QALY for intervention vs. control arm (QALY determined from Health Utilities Index	1 year after treatment initiation
Secondary	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)
Secondary	Change in daytime sleepiness	Epworth Sleepiness Scale	1 year after treatment initiation
Secondary	Adherence to positive airway pressure (PAP) therapy	Data includes number of days of PAP use and number of hours used per day.	1 year after treatment initiation
Secondary	Change in disease specific health-related quality of life	Sleep Apnea Quality of Life Index	3 months after treatment initiation
Secondary	Change in disease specific health-related quality of life	Sleep Apnea Quality of Life Index	1 year after treatment initiation
Secondary	Patient experience	Visit-Specific Instrument (VSQ-9)	3 months after treatment initiation
Secondary	Patient experience	Visit-Specific Instrument (VSQ-9)	1 year after treatment initiation
Secondary	Number of sleep diagnostic tests and sleep ambulatory care visits	Will measure sleep physician and ACP visits as well as polysomnography and ambulatory testing	1 year after treatment initiation
Secondary	Change in severity of sleep-disordered breathing	Respiratory disturbance index from ambulatory testing	3 months after treatment initiation
Secondary	Change in severity of sleep-disordered breathing	Respiratory disturbance index from ambulatory testing	1 year after treatment initiation
Secondary	Change in general health-related quality of life	Health Utilities Index	3 months after treatment initiation
Secondary	Change in general health-related quality of life	Health Utilities Index	1 year after treatment initiation