Tech-Enabled CM for AUD at Scale in Medicaid

Sponsor

DynamiCare Health (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04581499

Collaborator

RAND (Other), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

300

Enrollment

Location

Arms

25.9

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

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 adult Medicaid recipients.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Use Disorder Alcohol Dependence Drug Dependence	Combination Product: DynamiCare Motivation Support Program Other: Untreated or Routine Care Control Group	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Random-controlled trialRandom-controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Applying Technology-Enabled Contingency Management for Alcohol Use Disorder at Scale in a Medicaid Population

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	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 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.	Other: Untreated or Routine Care Control Group No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.

Arm

Intervention/Treatment

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.

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

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.

Other: Untreated or Routine Care Control Group

No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.

Outcome Measures

Primary Outcome Measures

Alcohol Use [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.

Secondary Outcome Measures

Engagement [32 weeks]
Percent of available funds earned as a composite measure.
Retention [32 weeks]
Monthly rates of retention in the program.
Drug Use Clinical Effectiveness [32 weeks]
Measured by DynamiCare saliva drug test results and weekly self-report.
Cost-effectiveness [12 months]
Medicaid healthcare utilization claims costs vs. prior 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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
1. 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.