Condition category
Mental and Behavioural Disorders
Date applied
01/05/2020
Date assigned
05/05/2020
Last edited
05/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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, constance.fung@va.gov

Trial website

Contact information

Type

Scientific

Primary contact

Dr Constance Fung

ORCID ID

http://orcid.org/0000-0002-0140-7932

Contact details

16111 Plummer Street
11E
North Hills
91343
United States of America
+1 8188917711
constance.fung@va.gov

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

4.4.19

Study information

Scientific title

Sleep EducatioN information sent Directly to patients: pilot study

Acronym

SEND-pilot

Study hypothesis

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

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

Study design

Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

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

28/08/2019

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1,900

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
3. Deceased

Recruitment start date

27/11/2019

Recruitment end date

06/03/2020

Locations

Countries of recruitment

United States of America

Trial participating centre

Department of Veterans Affairs Greater Los Angeles Healthcare
16111 Plummer Street (11E)
North Hills
91343
United States of America

Sponsor information

Organisation

Department of Veterans Affairs Greater Los Angeles Healthcare

Sponsor details

11301 Wilshire Boulevard
Los Angeles
90073
United States of America
+1 818-895-5861
scott.krahl@va.gov

Sponsor type

Government

Website

http://www.losangeles.va.gov/

Funders

Funder type

Not defined

Funder name

Kripke Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

30/06/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/05/2020: Trial’s existence confirmed by Department of Veterans Affairs Greater Los Angeles Healthcare System Institutional Review Board.