Remote Diagnosis and Management of Obstructive Sleep Apnea

Not Applicable

Completed

Conditions: Sleep Apnea - Obstructive
Telemedicine
Cost Effectiveness

Interventions: Device: autoadjusting continuous positive airway pressure

Registration Number: NCT03007745

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 435

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REVAMP	autoadjusting continuous positive airway pressure	Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
In-person management	autoadjusting continuous positive airway pressure	Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.

Primary Outcome Measures

Name	Time	Method
Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)	3 months	FOSQ-10 score ranges between 5 and 20 units; there is not threshold for normality; a higher score indicates higher functional outcome. Outcome Measure: Change from baseline in Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10), a self-administered disease specific quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A change in 1 unit is felt to indicate clinical significance.

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	3 months	Epworth Sleepiness Scale score ranges from 0 to 24 units; a value less than 11 is considered within normal range; a value of 11 or greater is considered to indicate the presence of subjective daytime sleepiness. Outcome measure: Change from baseline in the Epworth Sleepiness Scale (ESS), a self-administered subjective measure of daytime sleepiness, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A score change of 2 units is felt to indicate clinical significance.
Heath Survey Short Form - 12 (SF-12) Physical Component	3 months	Medical Outcomes Study Short Form (physical) score ranges from 0 to 100. A higher score indicates a higher level of health or functioning. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. Outcome measure: Change from baseline in physical component of the Health Survey Short Form-12 (SF-12), a self administered quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data).
Center for Epidemiological Studies Depression Questionnaire (CES-D)	3 months	Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item standard instrument devised using items from 5 validated depression scales. Likert-style responses for each symptom indicates how often in the past week the subject has experienced the symptom. Scores on the CES-DC range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression. Outcome measure: Change from baseline in Center for Epidemiological Studies Depression questionnaire (CES-D), a self-administered assessment of depression, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Insomnia Severity Index (ISI)	3 months	Insomnia Severity Index scores range from 0 to 28 units with higher values indicating greater severity. Scores less than 8 are considered in the normal range. Scores between 8 and 14 are considered subthreshold insomnia. Scores between 15 and 21 are considered clinical insomnia of moderate severity and scores between 22 and 28 are considered severe clinical insomnia. Outcome measure: Change from baseline of the Insomnia Severity Index (ISI), a aelf-administered assessment of insomnia, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Health Utilities Index (HUI)	3 months	Health Utilities Index (HUI-2), a self-administered questionnaire on overall functional health, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). HUI-2 classification system consists of 7 attributes including sensation, mobility, emotion, cognition, self-care, pain and fertility. HUI-2 utility values range from -0.03 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. To calculate a health utility score, health states for each response are converted using a look-up table and mathematical formula.
EuroQol (EQ-5D) VAS	3 months	EurQol-5D VAS is a visual vertical graduated analogue scale (ranging from 1 to 100) on which the participant self-rates health status. The score is reported as the units on the scale. Higher values represent a better health status. The EurQol-5D does not have a cut-off threshold to distinguish good versus poor health status. Outcome measure: Change from baseline in the EurQol-5D VAS score in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data).
Worker Alliance Inventory - Short Revised (WAI-SR)	3 months	WAI-SR is the 12-item questionnaire to assess three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of confidence, trust, comfort, and acceptance. Scores of each of the three key aspects range from 5 to 25 and the total WAI-SR score is the sum of the three subscored (maximum 75). Higher scores indicate greater alliance. Outcome measure: Assessment of participant-rated alliance with the practitioner in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Client Satisfaction Questionnaire (CSQ-8)	3 months	Client Satisfaction Questionnaire (CSQ-8) is an 8-item, self-administered structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Adherence to Autoadjusting CPAP Treatment	3 months	Objective assessment of adherence to CPAP treatment; average daily use over all days (hours)

Trial Locations

Locations (3): VA San Diego Healthcare System, San Diego, CA
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San Diego, California, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
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Decatur, Georgia, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Philadelphia, Pennsylvania, United States