The investigators propose a study to formally compare two Continuous Positive Airway Pressure
      (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice
      and we rely on patients to reach out to us if they are struggling with therapy (there will be
      no active outreach); 2) Case Management - in addition to "Usual Care" visits, patients CPAP
      use will be monitored and further encounters may be initiated with "struggler" CPAP users
      while "successful" users are passively followed.

      The investigators will evaluate measures of CPAP adherence, patient engagement and
      cost-effectiveness for the duration of 1 year.

      Our hypothesis is that "Case Management" will improve CPAP adherence and cost-effectiveness
      compared to "Usual Care". The investigators also hypothesize that targeting "strugglers" only
      in a management by exception (MBE) approach will be equally effective, but require less
      personnel time compared to targeting "all" patients.

CPAP Population Management

Obstructive Sleep Apnea (OSA)

Untreated obstructive sleep apnea (OSA) increases patient risks and burden on the healthcare
      system due to its high prevalence, impact on cardiovascular health, and daytime symptoms that
      cause deficits on daytime functioning. The yearly economic cost of OSA in Australia, with a
      population of about 25 million, is estimated to be $21 billion. Unfortunately, the
      effectiveness of continuous positive airway pressure (CPAP) therapy on improving patient and
      population outcomes is limited by suboptimal adherence with literature generally reporting
      adherence rates of 50-70% (defined by Medicare as ≥70% nights used ≥4 hours). The development
      of technology-based solutions is critical towards improving adherence, and this includes the
      use of remote patient monitoring, automation, and population management tools. Current CPAP
      devices are now wirelessly connected (eg, via cellular) which enables remote access by sleep
      medicine providers to access patient usage. Fox et al demonstrated the utility of remote
      monitoring in a randomized trial. New CPAP users that were remotely identified to have
      suboptimal use (and underwent a telephone encounter with a sleep medicine provider) showed
      significantly better 3 month CPAP use compared to the control group without monitoring (321
      minutes versus 207 minutes; p<0.0001). Our center also performed a randomized trial (Tele-OSA
      study) in which a similar process was applied but the monitoring and patient feedback was
      automated. Patients with <4 hours use for 3 nights in a row were automatically sent messages
      (typically via SMS text) encouraging use. The investigators demonstrated the
      cost-effectiveness of this automated approach (Auto-Monitoring), which resulted in improved
      CPAP adherence without an increase in manual intervention with a provider.

      Population management platforms capable of automatically risk stratifying patients (eg,
      automatically identifying poor users) may be another cost-effective technology-based tool by
      enabling a "management by exception" (MBE) follow-up process. This process concentrates
      provider effort on patients most at need by allowing providers to passively observe
      successful users and actively intervene only in CPAP strugglers. In our center, the
      investigators intend to implement this population management process by identifying CPAP
      strugglers at 1 month, 2 month, and 3 months after therapy initiation although impact on
      outcomes is unknown.

      Time Motion Pilot

      Our center proceeded with a preliminary implementation of this automated MBE process and
      performed a time motion study comparing time required to deliver care utilizing the
      population management process with automated risk stratification versus a non-automated
      process. The tasks performed were as follows: 1) Risk stratification (identifying patients
      with moderate-severe OSA), assessing CPAP Adherence (identifying those with >50% nights used
      at least 4 hours), telephone encounter (to troubleshoot issues with CPAP use), and
      documentation. The investigators demonstrated an 83% reduction in time required to follow-up
      a similar population of new CPAP users at any given time point (eg, 1 month, 2 months, etc.)
      While the results of this pilot (unpublished data) demonstrates significant improvement in
      care delivery efficiency, the impact on adherence remains unclear.

      Population Management Study

      The investigators propose a study to formally compare two CPAP follow-up pathways: 1) Usual
      care - a control group utilizing standard care practices with no active outreach; 2) Case
      Management - in addition to "Usual Care", other encounters may be initiated with CPAP
      strugglers while successful users are passively followed.

Case Management

Impact of Population Management Strategies on Continuous Positive Airway Pressure Adherence

Evaluate the impact each arm (Usual Care & Case Management) has on PAP adherence.

Chief of Service

Evaluate the cost-effectiveness of each arm by evaluating the number, estimated time and cost per encounter.

Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year.

Patients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as <70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the case manager convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year.

CPAP Population Management

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status