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| ID | Type | Description | Link |
|---|---|---|---|
| MT190002.01 | Other Grant/Funding Number | MTEC/MOMRP |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Naval Health Research Center | FED |
| US Air Force Medical Readiness Agency | UNKNOWN |
| KNOWESIS, Inc. |
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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.
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, NOCTEMâ„¢ 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 NOCTEMâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOCTEM only (NOCTEM) | Active Comparator | No external or internal facilitation |
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| External Facilitation (NOCTEM+EF) | Active Comparator | External facilitation only |
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| External and Internal Facilitation (NOCTEM+EF/IF) | Active Comparator | External and internal facilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Facilitation Support | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reach among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF | The ratio of clinicians who consent to participate and complete the NOCTEM training over the number of clinicians who received information about the training. | 3 month follow-up |
| Adoption among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF | The ratio of newly trained clinicians who use the NOCTEM system over the total number of clinicians who completed the NOCTEM training. | 3 month follow-up |
| Maintenance (sustainability) among clinicians randomized to NOCTEM only, NOCTEM+EF, or NOCTEM+EF/IF | 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). | 6-month follow-up |
| Change in Insomnia Severity Index | From Baseline to Post-Acute Intervention at Week 6 |
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Inclusion Criteria:
For clinicians:
For patients:
Exclusion Criteria:
For clinicians:
For patients (recommended):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92152 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33430955 | Derived | 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. |
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| UNKNOWN |
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| External Facilitation Support | 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. |
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| External and Internal Facilitation Support | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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