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Tech-Enabled CM for AUD at Scale in Medicaid

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ClinicalTrials.gov Identifier: NCT04581499
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 21, 2021
Sponsor:
Collaborators:
RAND
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
DynamiCare Health

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE October 9, 2020
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE January 1, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
Alcohol Use [ Time Frame: 32 weeks ]
The primary outcome measure is alcohol use, in terms of the number of weeks of abstinence confirmed by DynamiCare Breathalyzer tests and self-report.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2020)
  • Engagement [ Time Frame: 32 weeks ]
    Percent of available funds earned as a composite measure.
  • Retention [ Time Frame: 32 weeks ]
    Monthly rates of retention in the program.
  • Drug Use Clinical Effectiveness [ Time Frame: 32 weeks ]
    Measured by DynamiCare saliva drug test results and weekly self-report.
  • Cost-effectiveness [ Time Frame: 12 months ]
    Vermont Medicaid healthcare utilization claims costs vs. prior 12 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tech-Enabled CM for AUD at Scale in Medicaid
Official Title  ICMJE Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale in a Medicaid Population
Brief Summary This Phase II Small Business Innovative Research (SBIR) project is a clinical effectiveness and cost-effectiveness random controlled trial (RCT) of DynamiCare Health's innovative smartphone/smart debit card remote digital coaching program, which integrates Contingency Management, Recovery Coaching, and cognitive behavioral therapy (CBT), to address alcohol use disorder (AUD) in 300 adult Vermont Medicaid recipients.
Detailed Description This application proposes to continue clinical effectiveness and cost-effectiveness testing of the DynamiCare Health platform. This is an innovative smartphone-based digital coaching program that offers remotely-delivered contingency management (CM), Recovery Coaching, and cognitive behavioral therapy (CBT) content to address alcohol use disorder (AUD). CM, which uses financial incentives to reward abstinence and treatment attendance, is one of the most effective, evidence-based, and overlooked intervention for substance use disorders (SUD). DynamiCare, through its remote delivery system, has addressed the logistical barriers to adoption, and now seeks, through this proposal, to drive payer adoption. Our Phase 1 preliminary data shows that the intervention is acceptable and can be highly effective when delivered as a supplemental therapy to persons with AUD enrolled in treatment. Phase 2 proposes to partner with Vermont (VT) Medicaid to deploy and test the fully developed intervention in an RCT among individuals with AUD (n=300). Our goals are to: 1) Deploy the DynamiCare CM and digital coaching program at scale among VT Medicaid members with AUD; 2) determine clinical effectiveness; and 3) evaluate the cost-effectiveness and return-on-investment from the payer perspective. This study design addresses a lack in the CM literature of empirical evidence on the cost-savings for payers from CM. If CM can be shown to create cost-savings for payers, the final barrier to widespread adoption would fall. Overall, this Phase 2 project, which follows a highly successful Phase 1, will provide critical data to advance the utility of this innovative digital platform as it is deployed in the real world to help the millions of people with AUD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Random-controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Use Disorder
  • Alcohol Dependence
  • Drug Dependence
Intervention  ICMJE
  • Combination Product: DynamiCare Motivation Support Program
    DynamiCare is an evidence-based, multi-service platform that combines software, smartphone and pocket-sized alcohol and drug testing hardware, and recovery services, designed to remotely deliver evidence-based methodologies to facilitate people's motivation and accountability to overcome alcohol, nicotine and other drug use disorders, whether in formal treatment or not.
  • Other: Untreated or Routine Care Control Group
    No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.
Study Arms  ICMJE
  • Experimental: DynamiCare Motivation Support Program
    Intervention Group members will receive 32 weeks of remote Contingency Management (CM; financial motivational incentives), Recovery Coaching, substance testing, appointment reminding/tracking, and in-app Cognitive Behavioral Therapy (CBT). After 32 weeks, coaching, testing, appointment tracking and CBT will continue until an overall 12 months in the project is completed.
    Intervention: Combination Product: DynamiCare Motivation Support Program
  • Untreated or Routine Care Control Group
    Control participants will receive substance tests at the same frequency as Intervention participants, and the same incentive amounts for tests as treatment participants. Controls' payments, however, will not be contingent on positive/negative results, but rather only on valid, on-time submission. Controls will not receive coaching, CBT or rewards for appointments.
    Intervention: Other: Untreated or Routine Care Control Group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 5, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Vermont Medicaid members with Alcohol use Disorder (AUD)
  • At least 18 years old
  • Meet Diagnostic and Statistical Manual (DSM-5) criteria for current (past year) AUD, or recommended for care in the American Society of Addiction Medicine (ASAM) CO-Triage assessment
  • Speaks English
  • Has an Android or IOS smartphone

Exclusion Criteria:

  • Current suicidal intent
  • ASAM CO-Triage Level of Care needs higher than Level 3.1 (e.g., greater than community-based, working halfway house) and not receiving addiction treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: All genders are eligible
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David R Gastfriend, M.D. 855-539-6264 dgastfriend@dynamicarehealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04581499
Other Study ID Numbers  ICMJE DCH002
2R44AA026234-02 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DynamiCare Health
Study Sponsor  ICMJE DynamiCare Health
Collaborators  ICMJE
  • RAND
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Eric E Gastfriend, MBA DynamiCare Health, Inc.
PRS Account DynamiCare Health
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP