Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
研究概览
简要总结
The purpose of this study is to compare three different ways to deploy a clinician-decision support platform called NOCTEM COAST among behavioral health care providers who encounter patients with insomnia.
详细描述
Insomnia and other sleep disorders are highly prevalent among military service members and compromise readiness, health, and performance; increase the risk of injury; and are associated with astronomical healthcare costs. The first-line treatment recommended for insomnia is cognitive-behavioral treatment for insomnia (CBTI). However, the large number of service members who are in need of this treatment outnumber the clinicians who are experts in behavioral sleep medicine and who currently provide this intervention in a cost-efficient manner and in a way that is acceptable and accessible to patients and clinicians. To address this challenge and scale the delivery and access to evidence-based behavioral sleep interventions, NOCTEM™ has developed a digital health platform called COAST (Clinician Operated Assistive Sleep Technology). However, the most effective way to implement the use of digital sleep health technology, and its comparative impact on patient outcomes, remain to be determined. Therefore, this trial will compare three different ways to deploy the NOCTEM™ platform among behavioral health care providers who encounter patients with insomnia. Specifically, the study will evaluate and compare without external or internal support (NOCTEM), with external support (i.e., facilitation) offered by the NOCTEM team (NOCTEM+EF), and with external support and internal support from local champions (NOCTEM+EF/IF). The trial will also compare the overall magnitude of improvements in insomnia among patients who use the NOCTEM app with their provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For clinicians:
- •Completion of the first half of the workshop or similar Behavioral Sleep Medicine workshop in the past 6 months
- •Completion of the second half of the workshop, including a training session to learn about the use of the NOCTEM platform
- •See patients who present with insomnia
- •Use cognitive-behavioral techniques as part of their practice
- •For patients:
- •Are service members, veterans, or adult dependents who receive behavioral health care at one of the participating sites
- •Present with complaints of insomnia
- •Own a smart phone or smart device
- •Deemed suitable by their clinician to receive the sleep intervention via the NOCTEM platform
- •Confirm their willingness to use the NOCTEM app for sleep care with their provider
排除标准
- •For clinicians:
- •Do not provide direct behavioral health care to service members
- •Do not complete the two-part workshop and the 2-week proficiency training
- •For patients (recommended):
- •Suspected, diagnosed, or inadequately untreated sleep apnea (less than 4 hours of continuous positive airway pressure [CPAP] use per night)
- •Psychotic symptoms
- •A history of bipolar disorders
- •Women who are pregnant or breastfeeding and parents of children younger than 3 months of age
研究组 & 干预措施
NOCTEM only (NOCTEM)
No external or internal facilitation
干预措施: No Facilitation Support (Other)
External Facilitation (NOCTEM+EF)
External facilitation only
干预措施: External Facilitation Support (Other)
External and Internal Facilitation (NOCTEM+EF/IF)
External and internal facilitation
干预措施: External and Internal Facilitation Support (Other)
结局指标
主要结局
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
时间窗: 3 month follow-up
The ratio of clinicians who consent to participate and complete the NOCTEM training over the number of clinicians who received information about the training.
Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
时间窗: 6-month follow-up
Comparison of frequency of use of the NOCTEM platform by the trained clinicians, across the three groups (NOCTEM vs. NOCTEM+EF vs. NOCTEM+EF/IF).
Change in Insomnia Severity Index
时间窗: From Baseline to Post-Acute Intervention at Week 6
Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
时间窗: 3 month follow-up
The ratio of newly trained clinicians who use the NOCTEM system over the total number of clinicians who completed the NOCTEM training.
次要结局
未报告次要终点
研究者
Anne Germain
Principal Investigator
Noctem, LLC