Clinical trial NCT04572750: Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
Official title: Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Taking Benzodiazepines for Any Reason for 3 Months
Benzodiazepine Dependence
Keywords: insomnia
anxiety
benzodiazepine
self-help
patient education
electronic intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-10-01
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The EMPOWER-ED intervention is an app that runs on a smart phone or computer. It will provide education about the risk of benzodiazepine, a tool to create a method of self-tapering, and information on how to succeed at reducing or quitting benzodiazepine use. Individuals in the treatment condition of the trial will be given access to EMPOWER-ED on any platform they wish to use.
Primary purpose: TREATMENT

Brief summary: Benzodiazepines (e.g., Ativan, Xanax) are widely prescribed medications that are used mainly to treat anxiety and sleeping difficulties. Long-term use of benzodiazepine carries risks of physical dependence, addiction, falls and other accidents, and problems in thinking/concentrating. Researchers in Canada developed a printed self-help packet that enabled many individuals to reduce or cease taking benzodiazepines on their own. This study is designed to tailor that packet to the Veteran population, convert it to an app that people can use on their laptop or smart phone, and test whether the app helps promote benzodiazepine prescribing.

Detailed description: Background: Long-term use of benzodiazepine medication has been increasing sharply inside and outside of VA, raising the risk of cognitive decline, falls, and overdose among patients. A self-directed benzodiazepine tapering intervention known as EMPOWER was shown effective in a non-VA clinical trial, and within VA there is significant interest in tailoring it to and providing it for Veterans. Significance: Although often useful as short-term medications, when taken for extended periods benzodiazepines carry risk of cognitive decline and other brain damage, falls and other accidents, benzodiazepine dependence and opioid-benzodiazepine overdose (VA Pharmacy Benefits Management Academic Detailing Service, 2017). This is major concern within VA, which prescribes benzodiazepines to over 350,000 Veterans a year, 2/3 of whom take them long-term (i.e., 3 months or more) (VA Pharmacy Benefits Management Academic Detailing Service, 2017). Innovation: Because the EMPOWER intervention was paper-and-pencil based, it would be useful to convert it to an electronic version that worked on smart phones, tablets, and/or desktop computers. Accordingly, the proposed project intends to convert EMPOWER to electronic format and to tailor it to the needs and preferences of the Veteran population. Specific Aims: Aim 1: Tailor a promising non-VA benzodiazepine cessation intervention (EMPOWER) to Veterans and simultaneously convert it from paper-and-pencil to electronic format. Aim 2: Conduct a randomized clinical trial of the effectiveness of the tailored, electronic intervention (EMPOWER-ED) on VA primary care patients' benzodiazepine cessation/reduction and functional outcomes. Aim 3: Conduct a budget impact analysis to estimate the costs of implementing the EMPOWER-ED throughout VA. Methodology: This conversion and tailoring will be an iterative process that the project team will conduct via focus groups comprising Veterans, VA primary care providers, and VA operational partners. When the revised intervention, called EMPOWER-ED (for EMPOWER "Electronically Delivered"), is fully designed and has been successfully beta-tested by Veterans, its effectiveness will be evaluated in a randomized clinical trial with 170 Veterans who have been on benzodiazepines for at least 3 months. The primary hypothesis of the study is that those receiving EMPOWER-ED will be significantly more likely than controls to cease benzodiazepines entirely, and, to reduce their dose by at least 25%, at 6-month follow-up. The secondary hypothesis is that Veterans receiving EMPOWER-ED will also experience fewer anxiety symptoms, better sleep quality, and overall health/quality of life at 6-month follow-up. A supplemental analysis of benzodiazepine use only will be conducted using VA databases at 12 months to evaluate whether changes identified at 6 months persist over time. The VA operational partners of the project team (Pharmacy Benefits Management, Psychotropic Drug Safety Initiative, and Office of Connected Care) are committed to disseminating EMPOWER-ED if it proves successful. Therefore, a third aim of the study is to undertake a budget impact analysis to determine what the costs would be to implement EMPOWER-ED in the VA systemwide. Next Steps/Implementation: Because electronically-delivered interventions are inexpensive to disseminate once they have been developed, this project has an excellent chance to promote health care value by creating an easily scaled-up, method of reducing the prevalence of a widespread risk to Veterans' health.

Eligibility criteria: Inclusion Criteria:

* Veterans having a VA primary care provider and taking prescribed benzodiazepines for at least 3 months
* Have access to a smartphone, tablet, or computer

Exclusion Criteria:

* Individuals diagnosed with schizophrenia, dementia, seizure disorder, and/or spinal cord injury
* Individuals receiving palliative care

Primary outcomes:
measure: 25% Reduction in Benzodiazepine Use
timeFrame: 6 months
measure: Cessation of Benzodiazepine Use
timeFrame: 6 Months
Secondary outcomes:
measure: Anxiety
timeFrame: Baseline, 6 months
measure: Sleep Quality
timeFrame: Baseline, 6 months
measure: Overall Health and Quality of Life
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Keith N. Humphreys, PhD MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Michael A Cucciare, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cucciare MA, Abraham TH, Kemp L, White P, Marchant K, Hagedorn HJ, Humphreys K. Adapting the Eliminating Medications Through Patient Ownership of End Results Protocol to Promote Benzodiazepine Cessation Among US Military Veterans: Focus Group Study With US Military Veterans and National Veterans Health Administration Leaders. J Med Internet Res. 2022 Sep 19;24(9):e35514. doi: 10.2196/35514.
citation: Cucciare MA, Hagedorn HJ, Bounthavong M, Abraham TH, Greene CJ, Han X, Kemp L, Marchant K, White P, Humphreys K. Promoting benzodiazepine cessation through an electronically-delivered patient self-management intervention (EMPOWER-ED): Randomized controlled trial protocol. Contemp Clin Trials Commun. 2022 Sep 5;29:100994. doi: 10.1016/j.conctc.2022.100994. eCollection 2022 Oct.