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We continuously strive to develop and provide products and services to adequately meet your needs. This is to inform you of the successor model for which production must be discontinued.
NOTE: We have listed only the models in the following table which the customers ask frequently. If the model you require or the replacement parts for the discontinued model are not listed, please. Discontinued model: Successor model: Interchangeable parts with successor model Tips or Nozzles Heater Others HAKKO DASH No.N452/N453/N454 HAKKO FE-500 HAKKO FM-202 HAKKO FM-2021 Soldering iron for HAKKO FM-202.
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Methods In this non-blinded, multicenter, prospective study, all patients were started on continuous positive airway pressure (CPAP) with heated humidification and a wireless modem. They all received standardized CPAP education and setup. Patients in the TH group ( n = 58) received an automated series of text messages and/or e-mails that were triggered by preset conditions. Patients in the SOC group ( n = 64) received scheduled calls on days 1, 7, 14, and 30. Additional contacts were allowed for patients in both groups as deemed clinically necessary. Coaching labor was calculated by totaling the number and type of patient contacts and assigning historical time values. Results One hundred twenty-two patients were included in the final analysis.
There were no statistically significant differences between the TH and SOC groups for Medicare adherence (83 vs. 73%), daily CPAP usage (5.1 ± 1.9 h vs.
4.7 ± 2.1 h), CPAP efficacy (mean residual apnea-hypopnea index (3.0 ± 4.1/h vs. 2.8 ± 3.8/h), or change in Epworth Sleepiness Scale score (−5.8 ± 5.5 vs. –5.1 ± 5.9), although all trends favored the TH group. There was, however, a significant reduction in the number of minutes coaching required per patient in the TH vs.
SOC group (23.9 ± 26 vs. 58.3 ± 25, 59% reduction; p.
Introduction Obstructive sleep apnea (OSA) is the most common form of sleep-disordered breathing (SDB) and is typified by repetitive complete or partial collapse of the upper airway during sleep. The prevalence of OSA has been increasing steadily, in part due to the rise in obesity, with recent estimates suggesting that it affects ≥13% of men and 6% of women ,. This represents a considerable growth rate of 14–55% over the past two decades. OSA has been associated with numerous co-morbidities including hypertension, congestive heart failure, stroke, diabetes mellitus, and an increased risk of motor vehicle accidents –. OSA places a substantial financial burden on the healthcare system, with the cost of untreated OSA estimated to be US$67–165 billion.
First-line therapy for OSA is continuous positive airway pressure (CPAP), which improves symptoms including excessive daytime sleepiness, fatigue, memory impairment, and depressed mood ,. Long-term adherence with CPAP therapy has also been shown to improve blood pressure and cardiovascular morbidity and mortality.
Conversely, OSA symptoms return when CPAP therapy is discontinued. Unfortunately, CPAP therapy can take some time to get used to, and long-term adherence with therapy can be challenging. Historically, CPAP adherence rates have been ≈50% and when applying Medicare’s definition of adherence (≥4 h CPAP usage each night for 70% of nights during a 30 consecutive-day period anytime during the first 90 days of initial usage), the rate has been reported to be as low as 46% ,. However, more recent reports have documented adherence rates of 60–85% when more intensive follow-up and educational protocols are used. Lack of adherence with long-term regimens is an ongoing challenge for both patients and healthcare providers.
It has been estimated that non-adherence results in annual costs of $290 billion in the USA alone. World Health Organization (WHO) data indicate that patients with chronic diseases only adhere to their doctor’s long-term recommended therapy 50% of the time. Such data led to the conclusion that “interventions aimed at improving adherence would provide a significant positive return on investment through primary prevention (of risk factors) and secondary prevention of adverse health outcomes”. Telehealth (TH) has been defined as the delivery of health-related services and information via telecommunications technologies. The development and increasing availability of TH technology offers the opportunity to provide quality care while effectively managing costs. Chronic diseases require long-term commitment of resources for a successful therapy program and, as such, are an excellent area to apply TH technology.
U-Sleep (ResMed Corp) is a TH program that uses a multi-media approach to contact patients about their CPAP use. When usage falls, e-mail and text messages are sent to encourage patients to use CPAP more regularly. Electronic messages are also sent to the patient’s clinician, with triggered alerts to further assist in CPAP management.
Clinicians also remotely monitor their patients’ progress using U-Sleep technology via metrics including daily usage, apnea-hypopnea index (AHI) values, and leak. There are currently no published clinical research studies on use of U-Sleep technology as a tool to facilitate management of OSA patients. This study compared the U-Sleep program with a standard-of-care (SOC) program in patients with OSA receiving CPAP therapy for the first time. The primary objective was to compare adherence rates and healthcare professional (HCP) time (resource use) in the two groups. Study design.
CPAP continuous positive airway pressure, OSA obstructive sleep apnea Patients in the TH group were dispensed a CPAP device on Day 0, along with a pamphlet about U-Sleep, which was used to monitor adherence. U-Sleep is a secure, HIPAA-compliant, web-based application that is designed to receive CPAP device data and message patients and providers via text and/or e-mail based on a customizable set of rules. At the time of set up, patients were encouraged to log-in to the U-Sleep website from home so that they could follow their therapy. Sleep Data study staff were trained to set up and use the software, which was provided to patients at no charge. Initial patient contacts were triggered by ≥1 of five intervention points based on metrics (AHI, leak, therapy hours) (Table ). After initial contact, subsequent contacts were in response to an automated message or based on clinical judgment. All TH patients received a final phone call on day 90.
All patients were contacted at day 90 and asked to rate how well the follow-up program had met their expectations (on a scale from 1 to 5). In both groups, all phone contacts were performed by an RPSGT from Sleep Data using a standardized script. Additional telephone contacts or clinic visits were scheduled as deemed clinically necessary by the RPSGT for evaluation of issues such as high mask leak, appropriate pressure settings, AHI elevation, and daily usage. Tasks undertaken at clinic visits included mask refit, patient re-education and training with an RRT, provision of a copy of CPAP therapy data downloads, and machine performance evaluations. Sample size Equivalence in CPAP adherence was defined as a. Statistical analysis Primary endpoint analyses were generated for the intention-to-treat (ITT) and completed cases (CC) populations. The ITT population included all randomized patients except two who withdrew consent.
Patients with no compliance data, and one patient who never enrolled in the U-Sleep program, were considered non-adherent to CPAP; for those lost-to-follow-up, adherence results for the last available assessment were used. The CC population included patients who completed the study according to the protocol. Additional analyses were conducted in the CC population without imputation for missing values. Equivalence in CPAP adherence between the two treatment groups was tested using a two-sided 95% confidence interval (CI) for the difference in proportions.
The null hypothesis is rejected and equivalence established if the upper limit of the CI is ≤20%. The superiority hypothesis (TH adherence vs. Published average adherence) was tested using a two-sided exact binomial test of the TH adherence proportion compared to typical published average adherence; a two-sided 95% CI was calculated for the TH adherence proportion. Baseline characteristics and 90-day evaluations were compared between treatment groups using Student’s t test for continuous variables and chi-square or Fisher’s exact tests for categorical variables, as appropriate. Wilcoxon rank sum tests were employed when a non-parametric test of continuous variables was warranted.
Resource use There was a significant reduction in the mean aggregate time required to coach a patient in the TH versus SOC group (Table ). The number of follow-up clinic visits was similar in the two groups; only 17/58 patients (19 visits) in the TH group and 18/64 patients in the SOC group (20 visits) had a clinic visit. The mean total number of contacts was significantly lower in the TH group (2.2 ± 2.6/patient) compared with the SOC group (7.8 ± 4.1/patient; p. TH ( n = 58) SOC ( n = 64) p value Total time utilized Contact attempt, minutes (4 min each) 116 920 Follow-up contact, minutes (9 min each) 702 2214 Clinic visit, minutes (30 min each) 570 600 Total time for follow-up care, min 1388 3734 Time for follow-up care per patient, min Mean±SD a (range) 23.9 ± 26.3 (0–107) 58.3 ± 25.0 (18–133). Discussion In this study, TH monitoring of CPAP adherence using the U-Sleep platform required 59% less coaching labor than an SOC model, with equivalent adherence and efficacy. Adherence was achieved quickly, particularly in the TH group, nearly two thirds of whom had achieved Medicare-defined CPAP adherence within 30 days.
Previous studies examining the use of TH strategies for managing OSA patients have had varying results ,. Few have explored resource utilization. The TELEPAP study was a randomized, controlled clinical study in 51 patients with newly diagnosed OSA. The results did not show an advantage in adherence or efficacy for telemonitoring.
With respect to labor requirements, it was assumed that standard clinical care was the lower cost option. To our knowledge, there is only one other study documenting reduced labor requirements with TH. A significant reduction in nursing time per patient in CPAP users managed using a wireless, remote monitoring system (ResTraxx Online System®; ResMed) compared with control was documented.
DeMolles and colleagues used motivational interviewing techniques administered via an automated telephone-linked communication system to promote CPAP use. CPAP use significantly increased in the telemedicine group, by 1 hour at 6 months and 2 hours at 12 months; labor costs were not assessed. In a 2-month pilot study in 45 newly diagnosed OSA patients, telemonitoring was as effective as usual care in achieving CPAP adherence and efficacy, but economic efficiency and labor requirements were not addressed. Fox and colleagues randomized 75 patients in a 3-month study comparing SOC with a web-based telemonitoring application without automated messaging. The telemedicine group had increased CPAP usage, and use of telemedicine was a significant predictor of CPAP adherence. However, on average, telemedicine patients required an extra hour of research coordinator time to achieve the improvement.
The authors postulated that the additional labor cost associated with the TH approach might be worth the investment because of the improved adherence achieved. In the current study, there was no significant difference in adherence between the TH and SOC groups. This may be because the overall CPAP adherence rate in the SOC group was at the high end of those reported in the literature. The study was designed to detect a 20% difference in adherence between the SOC and TH groups, with an expected SOC group adherence rate of 70%. To detect a significant difference between the two groups, adherence in the TH group would need to have been 90%. Although the SOC techniques were clearly successful at obtaining adherence, they required significant time investment from HCPs, and this is expensive. We speculate that the decrease in resource use in the TH group can largely be attributed to a marked reduction in the requirement for HCPs to manually review adherence data, identify at-risk patients, and provide coaching.
Instead, automated notifications were delivered to the patient and their care provider. The reduction in labor required in the TH group was especially evident in the savings associated with coaching patients who reached adherence within the first 30 days (Fig.
The TH program did not require any additional labor if the patient was responding well to CPAP therapy. In contrast, the SOC model required an intense labor investment, particularly during the first month.
The TH technology allowed personnel resources to be diverted to patients who were non-adherent with therapy or were having one of a defined set of clinical complications (e.g., increased AHI, high leak). The rule sets that trigger patient and/or provider notifications can be customized based on the specific requirements and scope of each healthcare provider and patient population.
Patient satisfaction data indicated that the TH program met patient expectations just as effectively as the SOC program. There are some limitations to this study. Firstly, the ability of the study to detect a significant difference in adherence and daily usage between the TH and SOC groups was reduced by the exclusion of 18 patients from the final analysis and the high adherence rate in the SOC group. Of the 18 patients with insufficient data, 12 were from the TH group and 6 were from the SOC group. Examination of the characteristics of these patients did not provide any explanation for the difference in dropout rates between the two groups, and there is no evidence that treatment allocation played any role. Secondly, the findings of this study may not be widely generalizable for the following reasons.
Sleep Data’s SOC program utilizes frequent phone calls to follow and coach patients, which can be labor-intensive. Therefore, the coaching labor time saved with the U-Sleep program might be greater compared with less rigorous programs.
In addition, the TH arm relied heavily on access to a phone network or the internet, which, although commonplace, is by no means universal. In particular, some of the most challenging patients are those in lower socioeconomic groups who do not have access to these communication tools. Thus, some patients may not have the ability to participate in a TH program. Thirdly, the time ascribed to each follow-up encounter was based on Sleep Data’s historical averages and not measured directly. It is possible that although the number of phone calls made to TH patients was markedly reduced, their duration might have been longer.
Lastly, although there was close communication between Sleep Data and the prescribing physicians, CPAP therapy for all patients was primarily being managed by Sleep Data’s professionals; this study did not gather detailed information about interventions that might have been performed by the prescribing physician without Sleep Data’s knowledge. This study also has a number of strengths. The protocol was designed to overcome some of the limitations of previous studies involving telemedicine and OSA. This study included more than one study center, enrolled a larger number of patients and utilized objective adherence data on which to base conclusions. In addition, the determination of resource utilization associated with TH versus SOC has not been widely analyzed previously. Finally, the TH system used, U-Sleep, is a HIPAA-compliant program that is currently available and provides a standardized model that can be applied in a variety of clinical environments to optimize treatment of OSA patients.
As healthcare payment structures in the USA continue to evolve, there is an increasing pressure on healthcare providers to focus on business efficiency, especially cost management. According to the Centers for Medicare and Medicaid Services, total US healthcare spending was $2.8 trillion in 2012, up 3.7% versus 2011. Given such a heavy economic burden, more streamlined approaches to providing healthcare, such as TH, are necessary to maintain quality healthcare while reducing costs. In conclusion, the U-Sleep TH intervention was associated with excellent adherence to CPAP therapy in newly diagnosed OSA patients. The U-Sleep program also significantly reduced the amount of HCP time that was needed to achieve adherence and efficacy comparable to the SOC model. Whether these benefits translate into better cost effectiveness remains to be determined. Conflict of interest U-Sleep is a registered product of ResMed Corp.
Dominic Munafo has received research grants from ResMed Corp and is an employee of, and has an ownership interest in Sleep Data’s management company, Sleep Data Services, LLC. Maureen Crocker is an employee of ResMed Corp. William Hevener, Leslee Willes, Sarah Sridasome and Ma’an Muhsin have no conflicts of interest. Financial support for this study and for database creation was provided, in part, by ResMed Corp. Medical writing assistance from Nicola Ryan, independent medical writer, was funded by ResMed Corp. The design and conduct of the study and manuscript preparation were performed by Dominic Munafo, MD at Sleep Data, LLC.