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临床试验/NCT03018912
NCT03018912已完成不适用

A Survey Regarding Health and Well-Being

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 1,260 人开始时间: 2018年10月22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
1,260
试验地点
2
主要终点
Sleep Disorder Identification Rates

研究概览

简要总结

Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will improve recognition of patients with sleep disorders and can be utilized to track outcomes to sleep therapy.

详细描述

Background

The ability to identify patients with sleep disorders is recognized as increasingly important given its association with cardiovascular disease and impact on daytime functioning and quality of life. The Center for Disease Control recently characterized insufficient sleep as a public health issue, while also estimating that 1 in 25 adults admit to falling asleep while driving in a given month. 50 to 70 million Americans are affected by chronic sleep disorders and intermittent sleep problems, yet sleep problems are under-recognized; for example, 80 to 90% of adults with sleep disordered breathing remain undiagnosed. Sleep disorder screening tools are available, but are often limited by the following factors:

  1. Surveys may be extensive and thereby limit utilization
  2. Screening tools are often targeted for specific sleep disorders (e.g. obstructive sleep apnea (OSA)) rather than to more comprehensively screen for a wide range of sleep disorders
  3. Screening tools may not be useful in assessing outcomes during follow-up care

We propose the development of a sleep vital sign (VS) constructed as a simple-to-use survey tool that can assist primary care in identifying patients with sleep disorders and potentially useful to assess response to treatment. Improved identification of sleep disorders can potentially result in a benefit to the individual patient, to the health system, and to the greater public health.

Study Proposal We plan to investigate the use of a sleep VS (subjective patient reported metric) as a potential tool to identify patients with sleep disorders and to measure outcomes during follow-up care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients that have a scheduled office visit with their primary care physician.
  • Patients have to be Kaiser Permanente members

排除标准

  • Non-English speaking patients unable to understand English to complete the surveys.

研究组 & 干预措施

Sleep VS

Experimental

Patients check-in for their primary care physician visit and are provided a Sleep VS survey packet. Investigators or research associates will review the Sleep VS, and patients that screen positive on their Sleep VS will be asked to complete an extended set of sleep questions. A triaging algorithm will be available based on answers to the extended sleep questions to assist the primary care physician with assessment and triaging care. Patients that screen "negative" will not be asked the extended sleep questions nor will they be brought to the attention of the primary care physician and proceed with "usual care."

干预措施: Sleep VS (Other)

Usual Care

No Intervention

Patients check-in for their primary care physician visit and proceed with "usual care". Although the sleep vital sign will not be collected, the medical providers can still use the extended sleep questionnaire and triaging algorithm, if in the course of caring of the patient a potential sleep disorder is recognized.

结局指标

主要结局

Sleep Disorder Identification Rates

时间窗: 3 months

Compare the rate of identification of sleep disorders between each pathway

次要结局

  • Medications and Encounters(3 months)
  • Assessing response to treatment using Sleep VS(Every time patient completes the Sleep VS survey packet over a 3 month period.)
  • Referral Rates(3 months)
  • Sleep VS vs Sleep Questionnaires(Every time patient completes the Sleep VS survey packet over a 3 month period.)

研究者

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

Dennis Hwang, MD

Co-Chair, Sleep Medicine, Kaiser Permanente Southern California

Kaiser Permanente

研究点 (2)

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