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IIR 12-409 – HSR Study

IIR 12-409
Remote Ambulatory Management of Veterans with Sleep Apnea
Samuel T. Kuna, MD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, PA
Funding Period: February 2017 - January 2021
Through a clinical award from the VHA Innovation Program, our research team has created the Remote Veterans Apnea Management Portal (REVAMP), a personalized, interactive web-based platform that allows Veterans to receive comprehensive management of obstructive sleep apnea (OSA) without traveling to a sleep center. REVAMP (1) allows Veterans to respond to intake and follow-up questionnaires on the website; (2) displays wireless data transmitted from the patient's automatically-adjusting positive airway pressure (APAP) unit to the website; (3) enables Veterans to self-monitor their APAP use and effectiveness; and (4) auto-populates the patient questionnaire and PAP results into progress notes that can be exported to CPRS.

This prospective, randomized intervention in Veterans with OSA is comparing REVAMP management to in-person care. Aim 1 is to determine if REVAMP management is not clinically inferior to in-person care in terms of functional improvement and objectively monitored APAP adherence. Aim 2 is comparing differences in cost and quality-adjusted life years between the two models. In Aim 3, patient- and practitioner-centered formative evaluations will assess potential barriers to REVAMP's widespread implementation.

Veterans referred for OSA evaluation are being randomized to either REVAMP management or in-person care. Veterans randomized to REVAMP management (1) complete questionnaires and have access to videos about OSA and home sleep testing on the website; (2) be mailed a portable monitor to perform the home sleep test and return it by mail; (3) be evaluated by a sleep practitioner via home video teleconferencing (HVT) or phone interview to review the questionnaire and sleep study results; (4) if diagnosed with OSA, be prescribed an APAP unit with wireless modem for adherence tracking; (5) be able to view, along with their practitioners, their APAP use on REVAMP and their response to treatment based on follow-up questionnaires on the website, and (6) receive HVT or phone follow-up evaluations. Veterans randomized to the in-person pathway: (1) receive an initial in-person clinic evaluation and in-person instructions on how to perform the home sleep test; (2) complete questionnaires on the website to standardize data collection; (3) if diagnosed with OSA, be prescribed APAP and have in-person follow-up clinic visits; and (4) have their APAP adherence monitored by practitioners reviewing the wireless data on the APAP manufacturer's website.

Aim 1's primary outcome is the change in Functional Outcomes of Sleep Questionnaire (FOSQ-10) score following 3 months of APAP treatment. Objectively monitored APAP use is a secondary outcome. Non-inferiority analyses will compare the effectiveness of the two arms. We hypothesize that the change in FOSQ-10 score with REVAMP management will not be clinically inferior to that with in-person care.

In Aim 2, VA and non-VA total healthcare costs will be collected to test whether average cost is lower with REVAMP versus in-person care. Preference will be assessed by the SF-6D and EQ-5D. We will estimate the ratio of incremental costs to incremental quality-adjusted life years saved between REVAMP versus in-person management to test whether REVAMP management will have lower cost and equivalent outcomes. Formative evaluation in Aim 3 will use qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance, and patient satisfaction) to guide future implementation.

There are no findings at present. Participant recruitment and data collection are ongoing.

Estimated to be the third most common chronic disease in Veterans, OSA is associated with an increased risk of hypertension, heart attacks, strokes, depression, and driving accidents. Current in-person management at a sleep center is limiting access to care and has resulted in long patient wait times. This research study is evaluating an innovative website-based clinical pathway that will improve access to care of Veterans with OSA. The project may serve as the model for long-term care management for other common, chronic conditions in Veterans, including diabetes, obesity and hypertension.

External Links for this Project

NIH Reporter

Grant Number: I01HX001094-01A2

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Journal Articles

  1. Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9; 44(4). [view]

DRA: Other Conditions
DRE: Technology Development and Assessment
Keywords: Clinical Diagnosis and Screening, Outcomes - Patient, Rural
MeSH Terms: none

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