ONLINE SUPPLEMENT - PROTOCOL TITLE: Effect of Telemedicine Education and Telemonitoring on CPAP Adherence: The Tele-OSA Randomized Trial STUDY CENTER CONTACT: Kaiser Permanente, Fontana Medical Center Sleep Center 9961 Sierra Ave. Fontana, CA 92335 Telephone: 909-427-4432 Fax: 909-427-5664 Date of Protocol: October 2, 2014
Background Obstructive sleep apnea (OSA) is a prevalent condition which based on polysomnographic criteria affects 24% of men and 9% of women in the middle-aged population 1. Due to its high prevalence, its association with cardiovascular disease, and impact on neurocognitive function such as daytime vigilance, it carries a high healthcare burden in a given population. A recent assessment estimated that the yearly economic cost of OSA to Australia (population around 23 million) to be $21 billion 2. Thus, it is important for us to consider effective treatment not just for the individual, but cost effective management of the population. Continuous positive airway pressure (CPAP) therapy remains the gold standard treatment given its ability to provide near-complete physiologic effectiveness regardless of OSA phenotype. This therapy improves daytime vigilance and is currently the only therapy with substantial evidence suggesting improvement in cardiovascular risk. 3 The primary and well-known challenge with CPAP is the incomplete adherence of patients to this therapy (long-term CPAP compliance defined by percentage of days with at least 4 hours usage is typically reported to be around 50%.) 4,5,6 Advances in CPAP technology (such as with autocpap) have not been shown to enhance use. 7,8 Rather successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with OSA, potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. The impact of providing a system of accountability with further education/troubleshooting was reflected in a study showing improved CPAP adherence when usage was tracked daily (through a remote wireless process) followed by a telephone encounter if a problem with CPAP use was revealed. 9 Compared to a control group (usual clinical follow-up), average CPAP use per night was higher (321 minutes versus 207 minutes; p<0.0001) 3 months after initiation of therapy. The challenge with replicating this telemedicine workflow in a real-world setting is the laborintensive nature of tracking patients on a daily basis and logistics of dispensing and retrieving wireless modems. Furthermore, patient education is very time-consuming, and the ability to provide comprehensive education without built-in efficiencies could potentially affect the financial health of the provider. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and selfdirected methods of educating and follow-up is needed. Web-Based Education Emmi Solutions produces Web-based, simple to understand, healthcare related educational programs. These programs are interactive sessions that last about 15 minutes, educating patients on the risk of certain medical conditions or assists in preparing patients for procedures. Emmi has also produced OSA related programs: 1) OSA program this program educates patients on symptoms of OSA, provides animated videos depicting airway narrowing during OSA events, discusses health related risks of OSA such as cardiovascular disease and impact on daytime vigilance, preliminarily discusses CPAP as potential therapy, and discusses the testing process with ambulatory or in-lab polysomnography 2) CPAP program this program educates patients on how to properly use CPAP and wear the mask, discusses potential benefits of CPAP use including impact on health risks and daytime vigilance, provides methods of acclimating to CPAP, encourages patients to give a dedicated trial of CPAP even if initially having trouble, and instructs on how to care for their device and replace equipment. E2
Links to each of these programs are emailed to the patient and date of birth needs to be verified before the program will start. The programs ask the patient for feedback at regular intervals and provide opportunities throughout to make notes or write down questions that can be later printed. These programs are already approved for clinical use within Kaiser Permanente which has a contract with the vendor. Interactive Voice Response/Automated Feedback Messaging Interactive Voice Response Interactive Voice Response (IVR) is a protocol in which automated messages are delivered to patients to provide feedback regarding their CPAP use, intended to improve therapy adherence. While IVR refers to voice calls via telephone, we use this term to also include messages that are delivered by text messaging and email. The basic protocol involves the use of CPAP devices that wirelessly send usage data to a cloud platform. Automated algorithms will assess the usage data and send messages to the patient when there is suboptimal usage or to provide encouragement for successful use (See Protocol Figure 1 for programmed thresholds that will trigger a message). Specifically, the investigators will use CPAP devices with built-in modems (AirSense 10; ResMed Corp) which will send usage data via cellular network (Verizon or Sprint depending on signal availability) to cloud based platform (AirView; ResMed Corp). This data will be transferred to a second cloud-based platform (U-Sleep; Umbian), and it is this second platform that will automatically analyze the usage data and send the automated messages back to the patients. With each message, there will be a reminder to contact the sleep center for questions or problems regarding CPAP usage. Patients also have the ability to login to the U-Sleep platform at any time to track their own therapy information. Study Proposal The investigators plan to investigate the impact of adjunct web education and automated followup on CPAP use and other measurements of patient engagement. The Kaiser Permanente Fontana Sleep Disorders Center (Fontana, California) is an integrated sleep center that functions as a closed-loop system which balances diagnostic testing with a wide array of different follow-up programs. 10 The primary diagnostic pathway within our center for suspected OSA is with home sleep testing that begins with classroom education and includes setup of a home sleep testing device. Subsequent clinical visits are individual appointments, and patients undergo a 1 week autocpap trial if OSA is present. If appropriate, patients are subsequently ordered a CPAP for long-term use, and a 3 month follow-up visit is scheduled. Our study enrolls patients into one of four pathways: 1) One-fourth of our patients will follow our usual workflow that functions as our primary control group (Traditional Pathway); 2) One-fourth will follow the usual workflow with the addition of Emmi OSA education prior to the initial OSA class and Emmi CPAP education in those undergoing an autocpap trial (Telemedicine Education Pathway); 3) One-fourth will follow usual workflow with the addition of IVR follow-up (Telemedicine IVR Pathway); 4) One fourth will follow usual workflow with addition of both Emmi programs and IVR follow-up (Telemedicine Both Pathway) The specific aims of this pilot study are as follows: 1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy in comparison to Traditional pathway patients. 2. Assess impact of Telemedicine mechanisms on functional outcomes at 3 months after initiation of therapy in comparison to Traditional pathway patients. Methods Study Design This performance improvement initiative is structured as a randomized controlled trial designed to assess impact of automated educational and follow-up mechanisms on measure of patient engagement in patients with OSA. Consecutive patients triaged to home sleep testing for E3
suspected OSA are scheduled to attend an OSA class (the investigators schedule 5 classes of 13 patients per week). Classes will be variably assigned to follow one of the 4 Pathways (1 Traditional and 3 Telemedicine) thus result in group randomization (classes rather than individual patients are randomized) See Protocol Figure 2. Classes will be randomized 1:1:1:1. Traditional Pathway Patients will attend a 1 hour OSA Class (class size 13) where OSA education is provided and home sleep testing (Nox T3, Carefusion) is set up. These patients return the next day for individual appointments where study is scored and test results are discussed with patient. If study is consistent with OSA based on Apnea Hypopnea Index (AHI4%) at least 5/hour, patients undergo a 1 week autocpap trial. During this week, wireless remote monitoring (AirView; ResMed) is performed and troubleshooting is provided via telephone encounter if problems with CPAP use are identified. The autocpap is returned during an individual visit, and CPAP is ordered for long-term use based on trial results and patient feedback. Patients are scheduled a 3 month follow-up appointment but are also instructed to call their sleep center case manager (or visit the walk-in clinic) prior to that visit if there are problems with CPAP use. Telemedicine Education Pathway Patients follow our usual workflow as outlined in the Traditional Pathway. In addition, patients are emailed a link to view the Emmi OSA program within 2 weeks prior to their initial OSA class. If the patient tests positive for OSA and agrees to an autocpap trial, the patient is emailed a link to view the Emmi CPAP program. These patients are also scheduled for a 3 month followup visit to check CPAP usage. Telemedicine IVR Pathway Patients follow our usual workflow as outlined in the Traditional Pathway. Additionally, if CPAP is ordered for long-term therapy, the patient is enrolled into an IVR protocol (U-Sleep) that automatically analyzes the patient s CPAP use. If specific provider-defined thresholds are met (Protocol Figure 1), the platform will automatically deliver feedback messages to the patient (via patient s choice of phone call, text messaging, or email) with the intention of encouraging better CPAP use. Patients are instructed to contact the sleep center for any issues with their therapy. This platform also includes a method for patients to track their own usage online. Automated messaging mechanism will be active for 3 months after CPAP is ordered, after which the messaging will stop. These patients are also scheduled for a 3 month follow-up visit. Telemedicine Both Pathway Patients follow our usual workflow as outlined in the Traditional Pathway. In addition, patients are provided both Emmi education programs and IVR follow-up as previously outlined. These patients are also scheduled for a 3 month follow-up. Measured Variables Age, gender, body mass index, polysomnography respiratory parameters, ESS (Epworth Sleepiness Scale), Functional Outcomes of Sleep Questionnaire - 10 Questions (FOSQ-10) will be assessed at baseline. CPAP use, Epworth sleepiness scale, and FOSQ-10 will be assessed at 3 month follow-up. These measured variables are already part of our standard clinical assessment. The investigators will also evaluate measures of patient engagement and costeffectiveness of care by collecting information regarding adherence and number of provider encounters. Endpoints Primary endpoint: Difference in 3 month CPAP use (hours per night) between each Telemedicine pathway compared to Traditional pathway. Secondary endpoint: E4
1. Difference in 3 month FOSQ-10 between the each Telemedicine pathway compared to Traditional pathway. 2. Difference in CPAP use and FOSQ-10 between each of the Telemedicine pathways. Statistical Analysis This study investigates the impact of two telemedicine mechanisms on 90 day CPAP adherence. We will analyze their impact with an intention to treat analysis. Thus, we will include patients in the educational arms in the analysis regardless of whether they view the telemedicine education program; we will also include patients in the IVR (automated feedback messaging) arms in the analysis even if they decline the opportunity to use the messaging. There are four study arms. Baseline characteristics will be compared using a one-way ANOVA test to determine whether there is a significant difference among the four arms collectively. CPAP usage and related metrics will be analyzed using mixed-effects general linear models for continuous measures and mixed-effects logistic regression for Medicare compliance rates. Treatment will be treated as a fixed effect with a one-way ANOVA parameterization (to compare the four treatments) and with a two-way ANOVA parameterization (to evaluate the effects of the Tel-Ed and Tel-TM interventions). The HSAT class the patient attends will be treated as a random effect to account for potential correlations between patients in the same class. Student s T-test will also be used to compare HSAT class attendance rates between those that receive telemedicine education versus those that do not. Means and medians of healthcare encounter rates among the four arms will be calculated and one-way ANOVA will be used to analyze if appropriate. Tukey s post-hoc adjustment and Bonferonni correction will be applied when appropriate to take into account multiple comparisons. To detect a 0.5-hour increase in average nightly CPAP usage with a standard deviation of 2.2 hours (as found in the Fox et al. study) 9 with 80% probability, it was estimated that 283 patients per group would be required at the 0.05 significance level, while 127 patients per group would detect a 0.75-hour increase with 80% probability. We aim to enroll about 127 to 250 patients per group or 508 to 1000 total with CPAP prescribed, which should allow us to draw some useful conclusions. Taking into account that about 10% of patients will be excluded from the study (e.g. for previous CPAP use), HSAT class attendance rate is about 70%, rate of OSA diagnosis in those attending and undergoing HSAT is about 80%, and about 70% of those with OSA are eventually prescribed CPAP, we anticipate that 1440 to 2835 total patients (scheduled for the HSAT class) will need to be enrolled into the study. E5
Protocol Figures Protocol Figure 1: Interactive Voice Response (Automated Feedback Messaging Triggers and Messages) Threshold No CPAP data for 3 consecutive days CPAP usage <4h for 3 consecutive nights CPAP usage met Medicare criteria for adherence Message Kaiser Permanente Sleep Center is notifying you that data have not been received for the previous three days. For further info call [sleep center phone number]. Kaiser Permanente is notifying you that you have missed meeting your usage target for the past 3 nights. For further info call [sleep center phone number]. Congratulations! Kaiser Permanente is notifying you that you have achieved your Sleep Therapy Adherence goal. For further info call [sleep center phone number].
Patient referred to Sleep Center for suspected OSA triaged to Protocol Figure 2: Traditional versus Telemedicine Pathways HST=Home Sleep Testing; FOSQ10=Functional Outcomes of Sleep Questionnaire-Short Version; Questionnaire; IVR=Interactive Voice Response (includes option for text and email messaging via U-Sleep Platform; Umbian) TRADITIONAL PATHWAY TELEMEDICINE EDUCATION PATHWAY TELEMEDICINE IVR PATHWAY TELEMEDICINE BOTH PATHWAY Emmi OSA Emmi OSA OSA Class (up to 13) Sleep Questionnaire OSA Class (up to 13) Sleep Questionnaire OSA Class (up to 13) Sleep Questionnaire OSA Class (up to 13) Sleep Questionnaire Case Manager Individual Appointment HST Return Sleep Center AutoCPAP Setup Case Manager Individual Appointment HST Return Sleep Center AutoCPAP Setup Case Manager Individual Appointment HST Return Sleep Center AutoCPAP Setup Case Manager Individual Appointment HST Return Sleep Center AutoCPAP Setup Emmi CPAP Emmi CPAP Remote check by tech (AirView) Case manager individual appointment Sleep Center AutoCPAP Return Case manager individual appointment Sleep Center AutoCPAP Return Case manager individual appointment Sleep Center AutoCPAP Return Case manager individual appointment Sleep Center AutoCPAP Return IVR IVR Case Manager 3 month Follow-up CPAP compliance check ESS, FOSQ10 Case Manager 3 month Follow-up CPAP compliance check ESS, FOSQ10 Case Manager 3 month Follow-up CPAP compliance check ESS, FOSQ10 Case Manager 3 month Follow-up CPAP compliance check ESS, FOSQ10
Expected Results We anticipate that CPAP usage will be higher in the three Telemedicine Pathways (intervention pathways) at 3 months, and anticipate that it will be highest when both Emmi education and IVR(automated feedback messagin) are utilized. We also anticipate that the pathways that preeducate patients with the Emmi program will demonstrate a lower No show rate for the initial OSA class, higher rate of moderate/severe OSA patients agreeing to CPAP therapy, and better subjective outcomes based on sleep survey results. Significance of Research As stated in the Background section, OSA carries a significant burden on the healthcare system, thus providing effective therapy for OSA is critical for both the individual and for the population. CPAP therapy is limited by incomplete adherence to therapy, and the strategy likely most effective in improving use is with enhancing patient education and providing accountability through a follow-up system. As the healthcare system evolves, we will rely more heavily on technology to provide cost-efficient delivery of care, especially considering that patient education is a critical but very time-consuming exercise. If this study shows that a web-based education program and automated follow-up can improve CPAP use, this provides a potential process for sleep providers to adopt. Furthermore, the automated Web-based education can be particularly useful for non-sleep specialist directed care of OSA, such as primary care clinics in remote locations without proximity to a sleep center. The automated IVR/feedback messaging mechanism is potentially useful in managing other chronic sleep and non-sleep disorders. While we look forward to the continued implementation of smartphone applications and remote video encounters, we anticipate that asynchronic telemedicine mechanisms such as webeducation and automated follow-up processes will be an essential solution to the future of costeffective healthcare delivery. Citations 1 Young et al. The Occurrence of Sleep Disordered Breathing among Middle-Aged Adults. N Engl J Med 1993;328:1230 2 The Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010. 3 Montesi SB, Edwards BA, Malhotra A, Bakker JP. The effect of continuous positive airway pressure treatment on blood pressure: a systematic review and meta-analysis of randomized controlled trials. J Clin Sleep Med 2012;8:587-596 4 Kribbs NB, Pack AI, Kline LR, et al. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993; 147: 887-95. 5 Iftikhar IH, Valentine CW, Bittencourt LR, et al. Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a meta-analysis. J Hypertens 2014;32:2341-2350 6 Iftikhar IH, Hoyos CM, Phillips CL, Magalang UJ. Meta-analyses of the association of sleep apnea with insulin resistance, and the effects of CPAP on HOMA-IR, adiponectin, and visceral adipose fat. J Clin Sleep Med 2015;11:475-485 7 Nolan GM, Doherty LS, Mc Nicholas WT. Auto-adjusting versus fixed positive pressure therapy in mild to moderate obstructive sleep apnoea. Sleep. 2007 Feb;30(2):189-94. 8 Ryan S, Doherty LS, Nolan GM, McNicholas WT. Effects of heated humidification and topical steroids on compliance, nasal symptoms, and quality of life in patients with obstructive sleep apnea syndrome using nasal continuous positive airway pressure. J Clin Sleep Med. 2009 Oct 15;5(5):422-7. 9 Fox et al. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. 10 Hwang, Dennis. Pathway to Progress: Kaiser Permanente rethinks its sleep center delivery care model. Sleep Review Magazine. October 2012. E8