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BACKGROUND/RATIONALE:
Our overall goal is to improve access to care for veterans with suspected obstructive sleep apnea (OSA), a prevalent breathing disorder characterized by repetitive pharyngeal airway closure during sleep. Polysomnography, the current gold standard diagnostic tool, is expensive and requires specialized facilities. The result has been long patient wait times and restricted access to care. Commercially available portable monitors can diagnose patients with OSA and establish the continuous positive airway pressure (CPAP) setting needed for treatment. Despite the potential of these monitors to lower cost and increase patient access to care, their use in the home setting is still not widely accepted because it has not been definitively established that reductions (if any) in clinical efficacy following home testing are not clinically significant. Such a finding in conjunction with reduced costs would justify deployment of home testing as a cost effective alternative to gold standard in-lab testing. Thus, we propose to address barriers to care of veterans with suspected OSA by comparing the impact of home versus in-lab testing on patient compliance, function, cost, and cost-effectiveness.
OBJECTIVE(S):
Aim 1 will determine if patients with suspected OSA who receive home testing have adherence to CPAP treatment and functional improvements that are not clinically significantly inferior to patients receiving gold standard in-lab testing. Differences between home and in-lab testing may impact on our primary outcome measures: 1) objectively measured adherence to CPAP treatment, and 2) total score on the disease specific Functonal Outcomes Sleep Questionnaire. Aim 1 will be met through testing the following two hypotheses: Hypothesis 1a: Mean CPAP nightly hours of use in patients assessed through home testing will be no more than 0.75 hours less than patients assessed through in-lab testing. Hypothesis 1b: Mean increases in the Functional Outcomes of Sleep Questionnaire total score among patients assessed through home testing will be no more than one point less than patients assessed through in-lab testing.
Aim 2 will compare the differences in cost and quality-adjusted life years saved (QALYS) of home versus in-lab testing by estimation of the ratio of cost per QALYS saved. Preferences will be assessed using the Health Utilities Index 2 (HUI), a measure of the general public's preferences, and EuroQol (EQ-5D), a measure of patient's preferences. Hypothesis 2a: Average total health-care delivery cost is lower for veterans tested at home versus those tested in-lab. Hypothesis 2b: Because we believe that home testing will have lower costs and equivalent outcomes, we predict that the 90% upper limit of the cost per QALY ratio comparing home versus in-lab testing will be less than $100,000 (i.e., we will have 90% confidence that it is good value for the cost).
METHODS:
In this prospective randomized, controlled, clinical non-inferiority trial, patients referred to the Philadelphia and Pittsburgh VAMCs for evaluation for OSA will be randomized to either exclusively in-lab or home testing. In-lab testing will include polysomnography to diagnose OSA and titrate the the CPAP level for treatment. Self-administered home test-ing will consist of an overnight unattended study with a Type 3 portable monitor followed by a 1-week autoCPAP titration trial. Non-inferiority of clinical efficacy following 3 months of CPAP treatment will be primarily expressed in terms of patient adherence to CPAP, reductions in functional impairment, and reductions in subjective and objective sleepiness. Patient preference, medical service use and cost will be collected every 3 months over the entire observation period.
FINDINGS/RESULTS:
No results at this time.
IMPACT:
The finding that patients receiving in-lab versus home testing have similar clinical outcomes, and that home testing is more cost effective than in-lab testing should lead to wider acceptance of home testing of patients with suspected OSA, thereby increasing veteran access to care and reducing treatment costs.
PUBLICATIONS:
None at this time.
DRA:
Chronic Diseases
DRE:
Diagnosis and Prognosis
Keywords:
Sleep disorders
MeSH Terms:
none
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