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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Implementation; Digital Health Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NOCTEM only (NOCTEM)

No external or internal facilitation

Group Type ACTIVE_COMPARATOR

No Facilitation Support

Intervention Type OTHER

Clinicians will have full use of the NOCTEM platform. They will not have scheduled and/or structured contacts with the facilitation teams, however can reach out to the NOCTEM team or their local point of contact and coordinator with questions or technical issues that may arise.

External Facilitation (NOCTEM+EF)

External facilitation only

Group Type ACTIVE_COMPARATOR

External Facilitation Support

Intervention Type OTHER

Clinicians will have full use of the NOCTEM platform and the NOCTEM team will provide external facilitation via bi-weekly consult or supervision teleconference, or via telephone. The NOCTEM team will also be available by email and text messaging on an as needed basis.

External and Internal Facilitation (NOCTEM+EF/IF)

External and internal facilitation

Group Type ACTIVE_COMPARATOR

External and Internal Facilitation Support

Intervention Type OTHER

Clinicians will have full use of the NOCTEM platform and external facilitation support. In addition to external facilitation by the NOCTEM team a local point of contact and coordinator will serve as a more proximal facilitator.

Interventions

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No Facilitation Support

Clinicians will have full use of the NOCTEM platform. They will not have scheduled and/or structured contacts with the facilitation teams, however can reach out to the NOCTEM team or their local point of contact and coordinator with questions or technical issues that may arise.

Intervention Type OTHER

External Facilitation Support

Clinicians will have full use of the NOCTEM platform and the NOCTEM team will provide external facilitation via bi-weekly consult or supervision teleconference, or via telephone. The NOCTEM team will also be available by email and text messaging on an as needed basis.

Intervention Type OTHER

External and Internal Facilitation Support

Clinicians will have full use of the NOCTEM platform and external facilitation support. In addition to external facilitation by the NOCTEM team a local point of contact and coordinator will serve as a more proximal facilitator.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes