Plain English Summary
Background and study aims
Sleeping pills called benzodiazepines or benzodiazepine receptor agonists ("z-drugs") are often prescribed for insomnia. Some, but not all, studies suggest that sleeping pills are associated with increased risk of falls, hip fracture, cognitive impairment, and death in older adults. The purpose of this study is to investigate whether a program designed to promote discontinuation of sleeping pills improves health outcomes in older patients compared to a "control" program that provides information about general sleep information only.
Who can participate?
Individuals aged 65 years or older who obtain care from VA medical centers in VISN 19 (Colorado, Oklahoma, Utah, Montana, Wyoming, Idaho) and have been prescribed a benzodiazepine or z-drug from a VA pharmacy within the past 18 months.
What does the study involve?
We will randomly select patients 65 years or older who received sleeping pills within the past 18 months from VA facilities in VISN 19 to receive the active program alone, active program plus telephone call, or control program. The active program includes a mailed brochure on the risks of taking sleeping pills and information about a free, anonymous online cognitive behavioral therapy for insomnia program. The active program plus telephone call group receives the same brochure and also a call from research staff to promote the use of the online insomnia program. The control group includes a mailed brochure about the importance of sleep and information about a website about the importance of sleep. A mailed survey on insomnia severity is administered before and after the program. Usability of the mailed materials is assessed in the mailed survey after the program. Up to 50 participants will also receive a call from research staff at the end of the study to discuss their experience with the intervention materials. At six and twelve months after randomization, VA patient data will be extracted from the medical record and analyzed to assess sleeping pill, falls, hip fractures, and mortality rates.
What are the possible benefits and risks of participating?
There are no immediate direct benefits but participants may find the sleep material useful and may find it satisfying to know that participants may be helping to improve care for veterans with sleep problems in the future. There is little risk other than the possible unintended loss of privacy or breach of confidentiality resulting from human error.
Where is the study run from?
Department of Veterans Affairs Greater Los Angeles Healthcare (USA)
When is the study starting and how long is it expected to run for?
November 2019 to June 2021
Who is funding the study?
Kripke Trust (USA)
Who is the main contact?
Dr Constance Fung, email@example.com
Sleep EducatioN information sent Directly to patients: pilot study
Primary: A direct-to-patient mailing (that contains information about sleeping pill risks and how to access a free, anonymous online non-drug treatment for insomnia [cognitive behavioral therapy for insomnia program]) reduces benzodiazepines/benzodiazepine receptor agonist ("z-drug") prescriptions in older adults compared to a control condition.
Secondary: A direct-to-patient mailing (that contains information about sleeping pill risks and how to access a free, anonymous online cognitive behavioral therapy for insomnia program) improves health outcomes (e.g., insomnia severity, hip fractures, mortality) in older adults compared to a control condition.
Exploratory: Participants in the direct-to-patient mailing with a booster call will have reduced benzodiazepine/z-drug prescriptions compared to participants who do not receive a booster call.
Approved 28/05/2019, Department of Veterans Affairs Greater Los Angeles Healthcare System Institutional Review Board (VA Greater Los Angeles Healthcare System, 11301 Wilshire Boulevard (Mailcode 151), Los Angeles, CA 90073, USA; +1 310-268-4437; Elizabeth.Corey@va.gov), ref: PCC 2019-020113
Interventional randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
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).
Primary outcome measure
Active benzodiazepine and/or z-drug prescription listed in the electronic health record 6 months after randomization
Secondary outcome measures
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
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Participant exclusion criteria
1. History of seizures based on problem list in VA electronic health record
2. History of bipolar disorder based on problem list in VA electronic health record
Recruitment start date
Recruitment end date
Countries of recruitment
United States of America
Trial participating centre
Department of Veterans Affairs Greater Los Angeles Healthcare
16111 Plummer Street (11E)
United States of America
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)