Promoting Benzodiazepine Cessation Through an Electronically-delivered Patient Self-management Intervention (EMPOWER-ED)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Benzodiazepine Dependence; Taking Benzodiazepines for Any Reason for 3 Months
• Intervention / Treatment: Behavioral: EMPOWER-ED

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.

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System, Palo Alto, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMPOWER-ED; Individuals will be given access on their preferred platform to an electronic self-help app focused on reducing benzodiazepine use	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.
No Intervention: Control; Individuals will be provided care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
25% Reduction in Benzodiazepine Use	This outcome reflects an individual cutting their dose of benzodiazepine medication by one quarter or more	6 months
Cessation of Benzodiazepine Use	This outcome reflects an individual eliminating their benzodiazepine use from baseline to 6 month follow-up	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Change in anxiety from baseline will be measured using Spitzer's 7 item generalized anxiety disorder subscale.	6 months
Sleep quality	This outcome measures changes since baseline in sleep quality as assessed by the Patient-Reporter Outcomes Measurement System	6 months
Overall health and quality of life	Change since baseline in this variable will be assessed using the RAND Veterans SF-12	6 months
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Keith N. Humphreys, PhD MA, VA Palo Alto Health Care System, Palo Alto, CA; Principal Investigator: Michael A Cucciare, PhD, Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: insomnia; anxiety; patient education; self-help; benzodiazepine; electronic intervention
• Other Study ID Numbers: IIR 18-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No