ThErapy Adherence Management in Veterans

Study Overview
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Brief Summary
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The study is a prospective, randomized, controlled trial studying adherence to positive airway pressure therapy in a population referred to the VA system for the treatment of sleep disordered breathing. The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting Centers for Medicare & Medicaid Services (CMS) adherence requirements (use > 4 hours for >= 70% of days) at 90 days.

Detailed Description
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The primary aim of the study is to determine if, compared to standard care provided at a VA Sleep Center, the deployment of a structured adherence management program and a web-based information program designed for participants beginning positive airway pressure therapy results in a greater portion of participants meeting CMS adherence requirements (use > 4hrs on >=70% of nights) at 90 days. Secondary aims: Results in higher nightly use of therapy (hours per night and % of nights with at least 4 hours of use) at 90 days Results in participant satisfaction that is superior to current standard care Offers operational efficiencies or economic benefits to the health care facility (reduced staff time (sleep clinic and physician), equipment consumption, unplanned participant contacts or visits, and reduced overtime) Results in indirect benefits to participants (fewer clinic visits, less travel or in-clinic/ office visit waiting time)

Official Title
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ThErapy Adherence Management in Veterans: A Randomized Trial

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Behavioral: structured adherence management program
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 21 to 85 Diagnostic Apnoea-Hypopnoea Index (AHI) ≥ 15 determined by in lab polysomnography (PSG) or home sleep testing (HST) or by a sleep therapy device Eligible for treatment with Automatically adjusted CPAP or Automatically adjusted BiPAP Currently has a Smart Phone or home access (computer with internet access) to the internet based version of the software application Exclusion Criteria: Participation in another interventional research concerned with sleep disorders within the last 30 days Major uncontrolled medical condition that would interfere with the demands of the study, adherence to PAP, or the ability to commit to follow-up assessment including conditions such as poorly managed or controlled or advanced stages of pulmonary disease, cardiac disease, neurological disease, neuromuscular disease, cancer, and renal disease. Prior PAP use within the previous 12 months. Predominantly Central Apneas (≥ 50% central apneas) or Cheyne Stokes Respiration (CSR) (≥ 20% of Total Sleep Time (TST) with CSR) Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake or the requirement for supplemental oxygen (at night or continuous) or mechanical ventilation. Surgery involving the upper airway, nose, sinus, eye, teeth, or middle ear within the previous 90 days PAP therapy is otherwise medically complicated or contraindicated such as those with a difficult to size or adjust interface (mask) resulting in facial pain, skin irritation or trauma, or excessive air leaks

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After undergoing screening and enrollment, participants will be assigned to either standard care follow-up or to the patient adherence monitoring service (PAMS).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAMS service<br>Study participants will be randomly assigned to have their Continuous positive airway pressure therapy (CPAP) or Bilevel Positive Airway Pressure (BiPAP) therapy followed by a structured patient adherence management service (PAMS). Interventions: Call to patient by sleep coach on days 3,7,14,32,45, 60, and 75 after participants begin PAP treatment. At each time frame sleep coach reviews CPAP adherence data on EncoreAnywhere (EA) a cloud based program collecting adherence data via wireless modem on CPAP units. Calls will not be made at days 7 and 14 if adherence is good. If problems are identified and cannot be handled over the telephone the problems will be escalated to VA MD or CPAP respiratory therapy (RT) providers for direct intervention. All patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment. | Behavioral: structured adherence management program<br>* Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy<br>|
| Active Comparator: Standard Care (SCP)<br>Study participants will be randomly assigned to have their CPAP or BiPAP therapy followed by the current Sleep Center standard care process. This includes a telephone number that patients can call or problems and review of adherence data on EncoreAnywhere (EA) at 4 to 6 weeks after starting treatment. Patients are seen in sleep clinic by a VA MD sleep provider 3 months after starting treatment. | Behavioral: Standard of care<br>* Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase on CMS adherence requirements | The requirements are greater than 4 hours use for 70% of nights | at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nightly use of therapy | Hours per night and % of nights with at least 4 hours of use | at 90 days | 
| Participant satisfaction | Participants will complete at Patients Satisfaction Survey containing 5 questions about their satisfaction with CPAP treatment and the process of starting CPAP. There is a 5 point scale from very unsatisfied (1), unsatisfied (2), neutral (3), satisfied (4), very unsatisfied (5). Score can vary from 5 to 25. 30, | at 90 days | 
| Operational efficiencies and economic benefits to the health care facility | Reduced staff time (sleep clinic and physician) as evidenced by, unplanned participant contacts or visits over time | at 90 days |