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临床试验/NCT02191085
NCT02191085已完成不适用

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

University of Calgary2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Adherence to Positive Airway Pressure (PAP) Therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • referred to the FMC Sleep Centre for assessment of SDB
  • meet one of the three criteria for suspected severe SDB:
  • Respiratory disturbance index (RDI) >/= 30 events/hour on an ambulatory sleep test
  • Mean nocturnal oxygen saturation </= 85% on an ambulatory sleep test
  • 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
  • On supplemental oxygen therapy with high suspicion of SDB (as determined by physician review of referral)

排除标准

  • 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

结局指标

主要结局

Adherence to Positive Airway Pressure (PAP) Therapy

时间窗: 3 months after treatment initiation

Data includes number of hours used per night on all nights

次要结局

  • Change in Severity of Sleep-disordered Breathing(baseline and 1 year after treatment initiation)
  • Change in General Health-related Quality of Life(1 year after treatment initiation)
  • Quality Adjusted Life Years(1 year after treatment initiation)
  • Change in Daytime Sleepiness(1 year after treatment initiation)
  • Health Care Utilization(1 year after treatment initiation)
  • Total Healthcare Costs(1 year after treatment initiation)
  • Time From Date of Referral to Date of Treatment Initiation(Expected within 1 year (unknown due to nature of outcome))
  • Adherence to Positive Airway Pressure (PAP) Therapy(1 year after treatment initiation)
  • Change in Disease Specific Health-related Quality of Life(1 year after treatment initiation)
  • Patient Satisfaction(1 year after treatment initiation)
  • Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits(1 year after treatment initiation)
  • Change in Daytime Sleepiness(1 year after treatment initiation)
  • Health Care Utilization(1 year after treatment initiation)
  • Total Healthcare Costs(1 year after treatment initiation)
  • Time From Date of Referral to Date of Treatment Initiation(Expected within 1 year (unknown due to nature of outcome))
  • Adherence to Positive Airway Pressure (PAP) Therapy(1 year after treatment initiation)
  • Change in Disease Specific Health-related Quality of Life(1 year after treatment initiation)
  • Patient Satisfaction(1 year after treatment initiation)
  • Number of Sleep Diagnostic Tests and Sleep Ambulatory Care Visits(1 year after treatment initiation)
  • Change in Severity of Sleep-disordered Breathing(baseline and 1 year after treatment initiation)
  • Change in General Health-related Quality of Life(1 year after treatment initiation)
  • Quality Adjusted Life Years(1 year after treatment initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sachin R. Pendharkar

Dr.

University of Calgary

研究点 (2)

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