Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention

Benzodiazepine Dependence Clinical Trial

— EMPOWER-ED  

Official title:

Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04572750
• Other study ID #: IIR 18-026
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 170
• Est. completion date: September 30, 2025
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benzodiazepine Dependence
• Taking Benzodiazepines for Any Reason for 3 Months

Intervention

Behavioral:
• EMPOWER-ED
An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System, Palo Alto, CA	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 U — View 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 controlle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25% Reduction in Benzodiazepine Use	This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more	6 months
Primary	Cessation of Benzodiazepine Use	This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up	6 Months
Secondary	Anxiety	Change in anxiety from baseline will be measured using Spitzer's 7 item generalized anxiety disorder subscale.	6 months
Secondary	Sleep quality	This outcome measures changes since baseline in sleep quality as assessed by the Patient-Reporter Outcomes Measurement System	6 months
Secondary	Overall health and quality of life	Change since baseline in this variable will be assessed using the RAND Veterans SF-12	6 months
Secondary	Long-term Benzodiazepine cessation	Using VA databases, at 12 months the investigators will determine the proportion of individuals who stopped their benzodiazepine prescription since baseline and 6 months interviews.	12 months
Secondary	Long-term Benzodiazepine reduction	Using VA databases, at 12 months the investigators will determine the proportion of individuals who reduce their benzodiazepine dose by one quarter or more since baseline and 6 months interviews.	12 months