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Tech-Enabled CM for AUD at Scale

Primary Purpose

Alcohol Use Disorder, Alcohol Dependence, Drug Dependence

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DynamiCare Motivation Support Program
Untreated or Routine Care Control Group
Sponsored by
DynamiCare Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring contingency management, motivational incentives, cognitive behavioral therapy, CBT, recovery, recovery coach, recovery coaching, telehealth, digital therapeutic, remote monitoring, drug testing, breathalyzer, Medicaid, alcoholism, alcohol abuse, addiction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 3) Currently using: Have consumed at least one alcoholic beverage within the last 10 days, according to self-report, AND submits at least 1 positive substance test (breath or saliva) during the Welcome phase
  • 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.

Sites / Locations

  • DynamiCare Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

DynamiCare Motivation Support Program

Untreated or Routine Care Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Alcohol Use
The primary outcome measure is alcohol use, in terms of the number of weeks of abstinence confirmed by DynamiCare Breathalyzer tests and self-report.

Secondary Outcome Measures

Engagement
Percent of available funds earned as a composite measure.
Retention
Monthly rates of retention in the program.
Drug Use Clinical Effectiveness
Measured by DynamiCare saliva drug test results and weekly self-report.
Cost-effectiveness
Medicaid healthcare utilization claims costs vs. prior 12 months.

Full Information

First Posted
September 15, 2020
Last Updated
June 26, 2023
Sponsor
DynamiCare Health
Collaborators
RAND, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04581499
Brief Title
Tech-Enabled CM for AUD at Scale
Official Title
Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DynamiCare Health
Collaborators
RAND, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 adults.
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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Dependence, Drug Dependence
Keywords
contingency management, motivational incentives, cognitive behavioral therapy, CBT, recovery, recovery coach, recovery coaching, telehealth, digital therapeutic, remote monitoring, drug testing, breathalyzer, Medicaid, alcoholism, alcohol abuse, addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random-controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DynamiCare Motivation Support Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Untreated or Routine Care Control Group
Arm Type
Other
Arm Description
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 Type
Combination Product
Intervention Name(s)
DynamiCare Motivation Support Program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Untreated or Routine Care Control Group
Intervention Description
No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.
Primary Outcome Measure Information:
Title
Alcohol Use
Description
The primary outcome measure is alcohol use, in terms of the number of weeks of abstinence confirmed by DynamiCare Breathalyzer tests and self-report.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Engagement
Description
Percent of available funds earned as a composite measure.
Time Frame
32 weeks
Title
Retention
Description
Monthly rates of retention in the program.
Time Frame
32 weeks
Title
Drug Use Clinical Effectiveness
Description
Measured by DynamiCare saliva drug test results and weekly self-report.
Time Frame
32 weeks
Title
Cost-effectiveness
Description
Medicaid healthcare utilization claims costs vs. prior 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
All genders are eligible
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants in the study must have Alcohol Use Disorder (AUD) and: Be >18 years old Meet the DSM-5 criteria for current (past year) AUD, or be recommended for care in the ASAM CO-Triage assessment Have consumed at least one alcoholic beverage within the last 10 days, according to self-report Speak English Have an Android or iOS smartphone. Exclusion Criteria: Participants with current suicidal intent will be excluded as they require a higher level of care that cannot be provided by DynamiCare and our Recovery Coaches (hence, these individuals will be directly referred for clinical evaluation). Participants with ASAM CO-Triage level needs higher than Level 3.1 (e.g., greater than community-based, working halfway house) and not receiving addiction treatment will be excluded because they require inpatient treatment. Once the participant has received treatment, Recovery Coaches will reach out again to re-enroll the participant in the study if the participant wishes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric E Gastfriend, MBA
Organizational Affiliation
DynamiCare Health, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
DynamiCare Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.prnewswire.com/news-releases/vt-medicaid-gets-creative-on-addiction-during-covid-19-301108477.html
Description
Press release describing study launch and Vermont Medicaid's Chief Medical Officer's rationale.

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Tech-Enabled CM for AUD at Scale

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