Evaluating the Benefit of Home Support Provider Services for Positive Airway Pressure Therapy in Patients with Obstructive Sleep Apnoea: Protocol for an Ambispective International Real-World Study (Preprint)

Abstract

Adherence and persistence to positive airway pressure (PAP) therapy are key factors for positive health outcomes. Home support providers (HSPs) participate in home implementation and follow-up of PAP therapy for patients with obstructive sleep apnoea (OSA). In Europe, HSP levels of service are country (or area) specific, resulting in differences in content and frequency of patient interactions. However, no robust evaluation of the impact of these differences on clinical and patient outcomes has been performed.

The aim of the Assessment of the benefit of the HSP service level associated with positive airWay pressure treatment in patients with OSA on treatment Adherence and persistence: an International Real-world (AWAIR) study is to evaluate and compare the impact of different HSP service levels on PAP adherence and persistence in four European countries.

This real-world ambispective cohort study conducted in France, Belgium, Spain, and Portugal will recruit adults with OSA who started PAP therapy between 2019 and 2023 and were followed by an Air Liquide Healthcare HSP. Given the large number of eligible participants (around 150,000), the study will use a decentralised and digital approach. A patient video will present the study objectives and the participation process. A secure electronic solution will be used to manage patient information, consent and administer an online questionnaire. Retrospective data, collected during routine patient follow-up by the HSP, include the level of service and device data, notably PAP use. Prospective data collected using an electronic patient-reported outcome (ePRO) tool include health status, OSA-related factors, patient-reported outcome measures (PROMs), OSA/PAP literacy, patient-reported experience with PAP therapy and service measures (PREMs), and quality of life. Hierarchical models, adjusted for pre-identified confounding factors, will be used to assess the net effect of HSP services on PAP adherence and persistence while minimising real-world study biases and considering the influence of country-level contextual factors.

As of July 2024, the study has received approval in France, Portugal and in one region of Spain. The study will begin enrolment in quarter 4, 2024. We plan to obtain sequential study results, country by country, between March and June 2025. We hypothesise that higher levels of HSP services will be positively associated with adherence and persistence to PAP therapy.

The AWAIR study has a unique design, leveraging an unprecedented number of eligible participants, decentralised technologies and a real-world comparative methodology across multiple countries. This approach will highlight inter-country differences in terms of patient characteristics, PAP adherence and persistence, as well as PROMs, PREMs and satisfaction with the HSP service. By assessing the added value of HSP services, the results will support best practices for patient management and for decision making by payers and regulatory authorities.