Clinical trial NCT03007745: Remote Diagnosis and Management of Obstructive Sleep Apnea
Official title: Remote Ambulatory Management of Veterans With Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea - Obstructive
Cost Effectiveness
Telemedicine
Keywords: Continuous positive airway pressure
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-01-02
Enrollment: 435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and recognized as a major public health concern, most Veterans with this disorder are undiagnosed and therefore untreated. Access to sleep laboratories for testing is limited particularly for those Veterans living in rural areas and Veterans with disabilities that prevent travel to a sleep center. The goal of this study is to compare a web-based telehealth management strategy to in-person management. The telehealth pathway will enable Veterans to be diagnosed and treated without visiting a sleep center. The investigators believe that telehealth management will increase Veterans' access to this specialized care at a cost that is less than in-person delivery but with similar improvements in daytime function.

Detailed description: Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in Veterans and is associated with an increased risk of hypertension, heart attacks, strokes, depression, and driving accidents. Current in-person management at a sleep center limits Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote areas to travel long distances. This proposal will evaluate an innovative web-based clinical pathway to diagnose and manage Veterans with OSA. In Fiscal Year 13, the investigative team received a Veterans Health Administration (VHA) Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a personalized, interactive website that, when combined with other emerging telehealth technologies, is designed to improve access to care, reduce patient wait times, and allow Veterans to receive care without travelling to a sleep center. Veterans complete intake and follow-up questionnaires on the REVAMP website and perform an unattended home sleep test (HST) without in-person instructions. Sleep specialists review the findings with the patient during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses into templated progress notes that are exported to CPRS, the electronic medical record. Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure (APAP) units. These devices transmit data wirelessly to the website where treatment use and its effectiveness can be monitored by both Veterans and practitioners, thereby promoting patient self-management and productive patient-practitioner interactions.

The investigators' proposed prospective, randomized intervention will compare the clinical and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1 will determine if management with REVAMP is clinically non-inferior to in-person care in terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical effectiveness following 3 months of APAP treatment will be expressed in terms of improvement in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators' primary outcome measure. Adherence to APAP will be objectively monitored by wireless transmission of data from the participant's home unit. In Aim 2, patient preference, medical service use and cost will be collected every 3 months for the entire observation period to compare cost effectiveness of the two managements. Preference will be assessed by the Short Form-6D (SF 6D), and the EuroQol-5D (EQ-5D). Differences in the ratio of cost and quality-adjusted life years saved by REVAMP compared to in-person management will test the hypothesis that REVAMP management will have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance, and patient satisfaction) to inform clinicians, administrators and other stakeholders how to implement this innovative chronic disease pathway.

Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score. Analysis will also compare the mean daily hours of APAP use in participants in the two groups initiated on APAP treatment.

Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP management will be no more than one point less than that in participants receiving in-person management.

Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management will be no more than 0.75 hour less than that in participants randomized to in-person management.

Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY) between REVAMP management and in-person management. The perspective of the analysis will be that of the VA and the intention to treat analysis set will include all randomized participants.

Hypothesis 2a: Average total health-care delivery cost will be lower for participants receiving REVAMP compared to in-person management.

Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP manage-ment will be \> $100,000 (i.e., the investigators will have 90% confidence that REVAMP is good value for the cost).

Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's widespread implementation. Quantitative component: The investigators will track quantitative outcome measures across both groups including attrition, participant- and practitioner-rated therapeutic alliance (Working Alliance Inventory-Short Revised \[WAI-SR\]),9 and participant treatment satisfaction (Client Satisfaction Questionnaire \[CSQ-8\]).10 The investigators will compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms. Qualitative component: The investigators will explore participant- and practitioner-level perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as well as barriers and facilitators to participation in either clinical pathway through phone interviews with participants from the two intervention groups, participants who withdraw from either intervention, and staff who provide care through REVAMP.

Our primary aim was to demonstrate that the efficacy of REVAMP management is not clinically inferior to in-person care. Efficacy was measured as the change in FOSQ-10 score from pretreatment to 3 months following initiation of APAP treatment. An increase of more than 1 point in mean FOSQ score is felt to indicate an important clinical difference. Based on previous studies, we assumed a common SD=2.80. Similar calculations were performed for the APAP adherence outcome based on a non-inferiority delta of -0.75 hr/day and assuming a SD=2.2. 114 participants/group were estimated to be required to achieve at least 85% power to reject the null hypothesis, i.e., find that the change in FOSQ score among patients receiving the telehealth-based management is \> 1 point lower than that in participants assessed in-person and that APAP adherence among participants receiving the telehealth-based management is \> 0.75 hours lower that that in participants assessed in-person.

Eligibility criteria: Inclusion Criteria:

Veterans must meet the following inclusion criteria prior to enrollment:

* Referral to one of the participating sleep centers for evaluation of suspected OSA
* Access in the home to the internet, e-mail, and phone on all days
* Fluent in English as assessed on the initial phone contact

Exclusion Criteria:

Veterans will be excluded from the study for the following reasons:

* Unable or unwilling to provide informed consent and complete required questionnaires
* Previous diagnosis of:

  * obstructive sleep apnea (OSA)
  * central sleep apnea (50% of apneas on diagnostic testing are central apneas)
  * Cheyne-Stokes breathing
  * obesity hypoventilation syndrome
  * narcolepsy
* Previous treatment with positive airway pressure, non-nasal surgery for OSA, or current use of supplemental oxygen
* A clinically unstable medical condition in the previous 2 months as defined by a new diagnosis, e.g.:

  * pneumonia
  * myocardial infarction
  * congestive heart failure
  * unstable angina
  * thyroid disease
  * depression or psychosis
  * ventricular arrhythmias
  * cirrhosis
  * surgery
  * recently diagnosed cancer
* Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
* Women who are pregnant or women who are sexually active and of child-bearing age who are not using some form of contraceptive
* Unable to perform tests due to inability to communicate verbally, inability to read and write, and visual, hearing or cognitive impairment

Primary outcomes:
measure: Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)
timeFrame: 3 months
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 3 months
measure: Heath Survey Short Form - 12 (SF-12) Physical Component
timeFrame: 3 months
measure: Center for Epidemiological Studies Depression Questionnaire (CES-D)
timeFrame: 3 months
measure: Insomnia Severity Index (ISI)
timeFrame: 3 months
measure: Health Utilities Index (HUI)
timeFrame: 3 months
measure: EuroQol (EQ-5D) VAS
timeFrame: 3 months
measure: Worker Alliance Inventory - Short Revised (WAI-SR)
timeFrame: 3 months
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 3 months
measure: Adherence to Autoadjusting CPAP Treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: Samuel T. Kuna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):zsaa243. doi: 10.1093/sleep/zsaa243.