A pilot study of information about sleep mailed directly to patients
| ISRCTN | ISRCTN11530968 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11530968 |
| Secondary identifying numbers | 4.4.19 |
- Submission date
- 01/05/2020
- Registration date
- 05/05/2020
- Last edited
- 12/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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, constance.fung@va.gov
Contact information
Scientific
16111 Plummer Street, 11E
North Hills
91343
United States of America
 ORCID ID |
0000-0002-0140-7932 |
|---|---|
| Phone | +1 8188917711 |
| constance.fung@va.gov |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Sleep EducatioN information sent Directly to patients: pilot study |
| Study acronym | SEND-pilot |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | insomnia |
| 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). |
| Intervention type | Behavioural |
| 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 study start date | 28/08/2019 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 1,900 |
| Total final enrolment | 2009 |
| Key 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 |
| Key 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 3. Deceased |
| Date of first enrolment | 27/11/2019 |
| Date of final enrolment | 06/03/2020 |
Locations
Countries of recruitment
- United States of America
Study participating centre
North Hills
91343
United States of America
Sponsor information
Government
11301 Wilshire Boulevard
Los Angeles
90073
United States of America
| Phone | +1 818-895-5861 |
|---|---|
| scott.krahl@va.gov | |
| Website | http://www.losangeles.va.gov/ |
"ROR" |
https://ror.org/05xcarb80 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 31/10/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Constance Fung, MD, MSHS (constance.fung@va.gov). Data will become available on 31/12/2023 for 7 years. Limited deidentified datasets will be shared upon request for scientific analyses that have received approval from the requestor’s institutional review board and compliance/privacy officers after review and approval by the local VA IRB and Compliance/Privacy Officer. Written informed consent was not obtained from participants. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 06/10/2022 | 12/10/2022 | Yes | No |
Editorial Notes
12/10/2022: Publication reference added.
01/07/2022: IPD sharing statement added.
30/06/2022: The intention to publish date was changed from 30/06/2022 to 31/10/2022.
08/06/2021: The total final enrolment was added.
05/05/2020: Trial’s existence confirmed by Department of Veterans Affairs Greater Los Angeles Healthcare System Institutional Review Board.
