Background Insomnia is a prevalent and debilitating disorder commonly managed by family physicians. Insomnia guidelines recommend cognitive behavioral therapy for insomnia (CBTi) as the 'first-line' treatment. However, family physicians report limited time, knowledge, access, support, and referral options to manage patients with CBTi. Consequently, many patients with insomnia are prescribed potentially harmful and addictive sedative-hypnotic medicines (e.g. benzodiazepines). Family physicians require an insomnia management pathway that is specifically tailored to the guideline-recommendations, time demands, and capacity of family practice. Methods This mixed-methods implementation trial will test the feasibility, acceptability and effectiveness of a comprehensive digital insomnia management pathway in family practice. This novel pathway includes digital recruitment of family physicians, automatic identification of patients whose electronic medical records contain recent sedative-hypnotic prescriptions using a software management pathway and real-time notifications prompting physicians to refer patients to a well-established digital CBTi program. At least 10 family physicians and 375 patients with insomnia will be recruited. Physicians will be provided with an eBook to guide gradual sedative-hypnotic withdrawal. Feasibility and acceptability will be assessed from the perspective of patients and physicians. Effectiveness will be determined by co-primary outcomes: cessation of sedative-hypnotic use, and improvement in self-reported insomnia symptoms from baseline to 12-month follow-up. Analysis of trends in costs, cost-effectiveness and cost-utility analyses will be conducted from a societal perspective. Results and discussion This implementation trial will pave the way for future scaling-up of this insomnia management pathway to improve access to CBTi and reduce reliance on sedative-hypnotic medicines in family practice. Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001539123).
Contemp Clin Trials
Chronic insomnia, Cognitive behavioral therapy for insomnia, Family practice, General practice, Hypnotics, Primary care