Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial
Authors: Bramoweth Adam D , Hough Caroline E , McQuillan Amanda D , Spitznogle Brittany L , Thorpe Carolyn T , Lickel James J , Boudreaux-Kelly Monique , Hamm Megan E , Germain Anne 
Published: July 2023

Background
Chronic insomnia is one of the most common health problems among veterans and negatively impacts their health, function, and quality of life. Although cognitive behavioral therapy for insomnia (CBT-I) is the first-line recommended treatment, sedative-hypnotic medications remain the most common. Sedative-hypnotics, however, have mixed effectiveness, are frequently prescribed longer than recommended, and are associated with numerous risks and adverse effects that negatively impact veteran function. Meeting the treatment needs of veterans impacted by insomnia requires delivering gold standard behavioral care, like CBT-I, and the reduction of sedative-hypnotics through innovative methods.

Objective
The objective of this feasibility clinical trial is to test a digital CBT-I approach combined with deprescribing to improve the success of sedative-hypnotic reduction among veterans. The intervention combines Noctem Health Clinician Operated Assistive Sleep Technology (COAST), an effective and efficient, scalable, and adaptable digital platform to deliver CBT-I, with clinical pharmacy practitioner (CPP)–led deprescribing of sedative-hypnotic medications.

Methods
In this nonrandomized single-group clinical trial, 50 veterans will be recruited and enrolled to receive CBT-I delivered via Noctem COAST and CPP-led deprescribing for up to 12 weeks. Assessments will occur at baseline, posttreatment, and 3-month follow-up. The aims are to (1) assess the feasibility of recruiting veterans with chronic sedative-hypnotic use to participate in the combined intervention, (2) evaluate veterans’ acceptability and usability of the COAST platform, and (3) measure changes in veterans’ sleep, sedative-hypnotic use, and function at baseline, posttreatment, and 3-month follow-up.

Results
The institutional review board approved the study in October 2021 and the trial was initiated in May 2022. Recruitment and data collection began in September 2022 and is anticipated to be completed in April 2024. Aim 1 will be measured by tracking the response to a mail-centric recruitment approach using electronic medical records to identify potentially eligible veterans based on sedative-hypnotic use. Aim 2 will be measured using the Post-Study System Usability Questionnaire, assessing overall usability as well as system usefulness, information quality, and interface quality. Aim 3 will use the Insomnia Severity Index and sleep diaries to measure change in insomnia outcomes, the Patient-Reported Outcome Measurement Information System Profile to measure change in physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles, pain, cognitive function, and self-reported sedative-hypnotic use to measure change in dose and frequency of use.

Conclusions
Findings will inform the utility of a combined digital CBT-I and CPP-led deprescribing intervention and the development of an adequately powered clinical trial to test the effectiveness in a diverse sample of veterans. Further, findings will help inform potential new approaches to deliver care and improve access to care for veterans with insomnia, many of whom use sedative-hypnotics that may be ineffective and increase the risk for negative outcomes.

Trial Registration
ClinicalTrials.gov NCT05027438; https://classic.clinicaltrials.gov/ct2/show/NCT05027438

International Registered Report Identifier (IRRID)
DERR1-10.2196/47636