Comparing Two Methods to Improve CPAP Use among Patients with COPD and Obstructive Sleep Apnea — The O2VERLAP Study [Internet]

Excerpt

Background: Chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) are 2 major chronic conditions that affect millions of Americans. When OSA and COPD coexist, they are collectively referred to as “overlap syndrome.” OSA is prevalent in 10% to 15% of the 15 million patients diagnosed with COPD. Patients with both conditions are commonly prescribed medical devices for management, continuous positive airway pressure (CPAP) for OSA, and oxygen therapy for COPD. Because our early work found that most patients with OS use CPAP but a relatively low percentage of them use oxygen therapy, this study focused on improving the use of CPAP. Although CPAP is the most efficacious treatment for OSA, its use by patients is low relative to the prescription to use CPAP whenever asleep. Suboptimally treated OSA impairs next-day functioning.

Objectives: The project comprised 3 separate but related phases: (1) patient and stakeholder engagement activities; (2) focus groups to learn more from our patient community about the proposed comparative effectiveness research (CER) study; and (3) finalizing and carrying out the O₂VERLAP study, which was a large-scale, CER study examining 2 interventional approaches to improve treatment device adherence and outcomes. The main aims of this randomized controlled trial were as follows:

1. Aim 1: To compare the effectiveness of proactive care (PC; ie, a web-based peer-coaching education and support intervention based on scheduled interactions and outreach) vs reactive care (RC; ie, education and support based on limited scheduled interactions and patient-initiated contacts) on improving adherence to CPAP therapy in patients diagnosed with both COPD and OSA.

2. Aim 2: To compare the effectiveness of the 2 intervention groups on patient-centered outcomes, including daytime functioning, sleep quality, and daytime symptoms.

Methods: Participants were primarily recruited from 3 communities (COPD, OSA, and PCORnet) through electronic methods. They were given access to the study website to learn more and, if interested, could choose to provide e-consent and complete a self-report eligibility questionnaire. Inclusion criteria included being aged ≥40 years, having diagnoses of both COPD and OSA, and having been prescribed CPAP therapy. Participants were then randomly assigned to 1 of the 2 groups, with outcomes assessed at baseline, after an intervention period of 6 weeks, and after a follow-up at 12 weeks. Baseline CPAP adherence data were also collected for the 30-day period before randomization. The study primary outcome was CPAP adherence, defined as the amount of time that CPAP was worn each day at the prescribed pressure; the secondary outcomes were sleep quality, daytime functioning, and daytime sleepiness.

Results: The study enrolled 332 participants and randomly assigned 294. The mean (SD) CPAP adherence levels for the PC and RC groups were 6.1 (3.1) and 7.3 (2.4) hours/night (baseline), 6.3 (2.7) and 7.4 (2.2) hours/night (6 weeks), and 5.9 (3.0) and 7.2 (2.5) hours/night (12 weeks), respectively. The groups significantly differed in CPAP adherence at baseline (P < .001). There was no significant difference in change in CPAP adherence between the 2 study groups at either 6 weeks (difference = 0.18; 95% CI, −0.16 to 0.52; P = .29) or 12 weeks (difference = −0.05; 95% CI, −0.39 to 0.29; P = .78). There were also no significant differences in the change in patient-reported outcomes (ie, daytime functioning, sleep quality, and daytime sleepiness) at 6 weeks or 12 weeks.

Conclusions: In a group of patients with both COPD and OSA who used CPAP therapy, no difference was found between the provision of PC and RC. We found an unexpectedly high baseline CPAP adherence level, which meant that any improvement due to the intervention would have been very small and difficult to detect. The study was potentially underpowered to find a very small effect size, given the sample size. The high baseline CPAP adherence level may have been related to selection bias, due to the reliance on electronic recruitment methods (ie, email, social media, newsletters). Participants in both study groups were very satisfied with the care provided.

Limitations: The study was designed as a large, national, electronic recruitment-only study of patients diagnosed with both COPD and OSA. Because it relied on electronic recruitment, the study was limited to patients who had access to those electronic methods of outreach. Future studies of this kind would benefit from more stringent inclusion and exclusion criteria to ensure the studies are limited to patients who are having some difficulty with CPAP use or to new users.