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

NCT ID: NCT02191085

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2019-12-31

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.

Conditions

Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Fast Track

In the "Fast Track" arm, an ACP will perform the initial assessment and will determine the management plan with the patient.

Group Type: ACTIVE_COMPARATOR

Fast Track

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Lung Association

UNKNOWN

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Sachin R. Pendharkar

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sachin R Pendharkar, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Foothills Medical Centre Sleep Centre

Calgary, Alberta, Canada

Countries

Canada

References

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REB13-1280

Identifier Type: -

Identifier Source: org_study_id