Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform

Not Applicable

Active, not recruiting

• Conditions: Implementation; Digital Health; Chronic Insomnia
• Interventions: Other: External Facilitation Support; Other: No Facilitation Support; Other: External and Internal Facilitation Support

• Registration Number: NCT04366284
• Lead Sponsor: Noctem, LLC

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Study Start: 2020-09-01
• Status Verified: 2023-06
• Primary Completion: 2023-06-30
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External Facilitation (NOCTEM+EF)	External Facilitation Support	External facilitation only
NOCTEM only (NOCTEM)	No Facilitation Support	No external or internal facilitation
External and Internal Facilitation (NOCTEM+EF/IF)	External and Internal Facilitation Support	External and internal facilitation

Primary Outcome Measures

Name	Time	Method
Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF	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	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	From Baseline to Post-Acute Intervention at Week 6
Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF	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.

Trial Locations

Locations (1)

Naval Health Research Center; 🇺🇸 San Diego, California, United States