Clinical trial NCT04366284: Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
Official title: Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implementation; Digital Health
Chronic Insomnia
Keywords: Cognitive-Behavioral Therapy for Insomnia
Implementation-Effectiveness
Dissemination and Implementation Research
Lead sponsor: Noctem, LLC
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
name: Naval Health Research Center
name: US Air Force Medical Readiness Agency
name: KNOWESIS, Inc.
First posted: 2020-04-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
timeFrame: 3 month follow-up
measure: Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
timeFrame: 3 month follow-up
measure: Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF
timeFrame: 6-month follow-up
measure: Change in Insomnia Severity Index
timeFrame: From Baseline to Post-Acute Intervention at Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Health Research Center
state: California
Study officials:
References:
citation: Germain A, Markwald RR, King E, Bramoweth AD, Wolfson M, Seda G, Han T, Miggantz E, O'Reilly B, Hungerford L, Sitzer T, Mysliwiec V, Hout JJ, Wallace ML. Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial. Trials. 2021 Jan 11;22(1):46. doi: 10.1186/s13063-020-04974-z.