A pilot study of information about sleep mailed directly to patients

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: After the initial opt‐out period, eligible participants are randomized to one of three groups: 1) Active program: mailed information about sleeping pill risks and a free, anonymous online cognitive behavioral therapy for insomnia website, 2) Active program plus booster telephone call: mailed information about sleeping pill risks and a free, anonymous online cognitive behavioral therapy for insomnia website plus a booster telephone call asking about content of brochure and encouraging the participant to visit the online cognitive behavioral therapy for insomnia program described in the mailed information, or 3) Control program: mailed information about the importance of sleep (non‐directed information) and information about a free, anonymous website about the importance of sleep (non‐directed information). Stratified block randomization is used for group allocation (Stata uniform() function). Stratification variables: whether or not the medication is approved by the US Food and Drug Administration (FDA) for insomnia and chronicity of the prescription (>= 3 months vs < 3 months). CONDITION: insomnia ; Mental and Behavioural Disorders PRIMARY OUTCOME: Active benzodiazepine and/or z‐drug prescription listed in the electronic health record 6 months after randomization SECONDARY OUTCOME: ; 1. Insomnia severity (measured using the Insomnia Severity Index) 6 months and 12 months after randomization; 2. Active benzodiazepines and/or z‐drug prescriptions listed in the electronic health record 12 months after randomization; 3. Hip fracture rate at 6 and 12 months after randomization measured using the electronic health record; 4. Mortality rate 6 and 12 months after randomization measured using the electronic health record; 5. Usability of mailed program materials and websites measured using a mailed survey at the end of the program; 6. Acceptability of mailed program materials and websites measured using a mailed survey at the end of the program; INCLUSION CRITERIA: 1. Aged 65 years or older 2. Obtain care from VA medical centers in VISN 19 (Colorado, Oklahoma, Utah, Montana, Wyoming, Idaho) 3. Have been prescribed a benzodiazepine or z‐drug from a VA pharmacy within the past 18 months
Epistemonikos ID: 53439ff0a6188831ebb045e572ce3510e729d3fb
First added on: Aug 24, 2024