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ArticleTrials2025

The Study in Outpatient Medicine using Nudges to Improve Sleep (SOMNUS): study protocol for an 18-month factorial, cluster-randomized trial to increase guideline-concordant treatment of insomnia in primary care.

Jonathan N Cloughesy, Jeffrey A Linder, Tara K Knight, Stephen D Persell, Mark D Sullivan, Daniella Meeker, Tiffany Brown, Ji Young Lee, Emily P Stewart, Craig R Fox and 5 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06640023 (The Study in Outpatient Medicine Using Nudges to Improve Sleep), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06640023 naactive not recruitingnot on this map

The Study in Outpatient Medicine Using Nudges to Improve Sleep: The SOMNUS Trial

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2024 to 2027Enrolled444ConditionsInappropriate PrescribingArmsZ-drug Default Quantity, Redirection + Accountable Justification
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Jonathan N CloughesyLeonard D. Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, CA, USA. cloughes@usc.edu.ORCID http://orcid.org/0000-0002-6531-038X
Jeffrey A LinderDivision of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Tara K KnightLeonard D. Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, CA, USA.
Stephen D PersellDivision of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Mark D SullivanDepartment of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.
Daniella MeekerDepartment of Biomedical Informatics & Data Science, Yale School of Medicine, New Haven, CT, USA.
Tiffany BrownDivision of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Ji Young LeeDivision of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Emily P StewartLeonard D. Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, CA, USA.
Craig R FoxAnderson School of Management, University of California Los Angeles, Los Angeles, CA, USA.
Noah J GoldsteinAnderson School of Management, University of California Los Angeles, Los Angeles, CA, USA.
Ria Grace SumitroSol Price School of Public Policy, University of Southern California, Los Angeles, CA, USA.
Michael V VitielloDepartment of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.
Wendy J MackDepartment of Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Jason N DoctorLeonard D. Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, CA, USA.

Funding

Study in Outpatient Medicine using Nudges to improve Sleep: The SOMNUS TrialR01HL167023 · NHLBI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI JASON N. DOCTOR · 2023 to 2026
$2.6M
NHLBI NIH HHS R01 HL167023NHLBI NIH HHS R01HL167023
6 · The paper itself

Abstract

backgroundGuidelines support cognitive behavioral therapy for insomnia (CBT-I) as the first-line treatment for chronic insomnia. However, the most widely prescribed treatments are pharmacological sedatives referred to as "Z-drugs," which are not recommended as first-line or for long-term use. The Study in Outpatient Medicine Using Nudges to Improve Sleep (SOMNUS) is an 18-month, factorial, cluster-randomized trial designed to evaluate the effectiveness of behavioral interventions that nudge primary care clinicians to provide guideline-concordant treatment for patients with insomnia by facilitating CBT-I use and discouraging Z-drug orders.

methodsThe SOMNUS trial takes place at Northwestern Medicine, an academic health system located in and around Chicago, IL, USA, and will enroll 444 primary care clinicians working in 64 outpatient clinics. Using a 2 × 2 factorial design, clinicians will be clinic-cluster-randomized to receive one of two nudges embedded in the electronic health record (EHR), their combination, or neither. The first nudge sets the default dispense quantity for new Z-drug orders to 10 pills with no refills. The second nudge is a just-in-time prompt with a one-click option to align orders with guidelines and requires clinicians to enter a justification if prompt recommendations are not followed. The primary outcome is the change in encounter-level Z-drug pill count from the 18 months before through the 18 months after the intervention period begins. Secondary outcomes will assess CBT-I referrals, monthly Z-drug pill count, Z-drug treatment duration, and benzodiazepine pill count. DISCUSSION: The SOMNUS trial will use EHR-integrated behavioral nudges that aim to increase guideline-concordant treatment of insomnia in primary care. Results can inform scalable approaches to improve insomnia treatment.

trial registrationClinicalTrials.gov NCT06640023. Prospectively Registered on October 15 2024.

Indexed as

Ambulatory CareCognitive Behavioral TherapyGuideline AdherenceHypnotics and SedativesPrimary Health CareSleepSleep Initiation and Maintenance DisordersElectronic Health RecordsHumansMulticenter Studies as TopicPractice Guidelines as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeHypnotics and SedativesBehavioral economicsClinical decision-makingClinical decision supportCognitive behavioral therapy for insomniaDefaultsElectronic health recordInappropriate prescribingNudgesZ-drugs

Identifiers

PMID41430294
PMCPMC12837018

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.