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临床试验/NCT02279901
NCT02279901已完成不适用

Impact of Interactive Web-Based Education and Interactive Voice Response (Automated Follow-up) Programs on CPAP Adherence for the Treatment of Obstructive Sleep Apnea

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 1,873 人开始时间: 2014年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,873
试验地点
1
主要终点
Average hours of CPAP use per night: experimental pathway vs. traditional pathway

研究概览

简要总结

The primary and well-known challenge with continuous positive airway pressure (CPAP) is the incomplete adherence of patients to this therapy. Successfully improving CPAP use is likely through emphasizing patient education regarding the risks associated with obstructive sleep apnea (OSA), potential benefits of therapy, teaching techniques to acclimate to CPAP, and providing a system of accountability through a follow-up process. With the changing landscape of healthcare reimbursement which emphasizes achieving positive clinical outcomes, discovering more automated and self-directed methods of educating and follow-up is needed.

The investigators plan to investigate the impact of adjunct Web education and automated follow-up on CPAP use and other measurements of patient engagement. 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 usual standard of care.
  2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of healthcare utilization at 3 months after initiation of therapy in comparison to usual standard of care.

详细描述

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. 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. 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. 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%.) Advances in CPAP technology (such as with autoCPAP) have not been shown to enhance use. 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. 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 labor-intensive 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 self-directed methods of educating and follow-up is needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinical suspicion of obstructive sleep apnea (OSA)
  • •Appropriate for home sleep testing
  • •No prior use of CPAP or other therapies for OSA

排除标准

  • •Commercial drivers
  • •Complex sleep disorders (e.g. CSA)
  • •No DME (durable medical equipment) insurance coverage
  • •Declines CPAP therapy

研究组 & 干预措施

Traditional

No Intervention

Patients will attend a 1 hour OSA Class where OSA education is provided and home sleep testing 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 AHI4% at least 5/hour, patients undergo a 1 week autoCPAP trial. During this week, wireless remote monitoring is performed and troubleshooting is provided via telephone 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 prior to that visit if there are problems with CPAP use.

Telemedicine Education Pathway

Experimental

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 follow-up visit to check CPAP usage.

干预措施: Telemedicine Education (Behavioral)

Telemedicine IVR Pathway

Experimental

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 that automatically analyzes the patient's CPAP use. If specific provider-defined thresholds are met, the platform will automatically deliver feedback messages to the patient (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.

干预措施: IVR (Behavioral)

Telemedicine Both Pathway

Experimental

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.

干预措施: Telemedicine Education (Behavioral)

Telemedicine Both Pathway

Experimental

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.

干预措施: IVR (Behavioral)

结局指标

主要结局

Average hours of CPAP use per night: experimental pathway vs. traditional pathway

时间窗: 3 months

Difference in 3 month CPAP use (hours per night) between each telemedicine (experimental) pathway compared to the traditional (control) pathway

次要结局

  • ESS (Epworth Sleepiness Score)(3 months)
  • FOSQ-10 (Functional Outcomes of Sleep Questionnaire - 10 Questions)(3 months)
  • Adherence to provider encounters(3 months)
  • Healthcare utilization(3 months)
  • Average hours of CPAP use per night: experimental pathway vs. experimental pathway(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis Hwang, MD

MD

Kaiser Permanente

研究点 (1)

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