Alcohol Dependence, Alcohol Use Disorder, Drug Dependence
Conditions
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
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.
Interventions
COMBINATION_PRODUCTDynamiCare 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.
OTHERUntreated or Routine Care Control Group
No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.
Sponsors
RAND
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
DynamiCare Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Random-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants in the study must have Alcohol Use Disorder (AUD) and: 1. Be \>18 years old 2. Meet the DSM-5 criteria for current (past year) AUD, or be recommended for care in the ASAM CO-Triage assessment 3. Have consumed at least one alcoholic beverage within the last 10 days, according to self-report 4. Speak English 5. Have an Android or iOS smartphone.
Exclusion criteria
1. 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). 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed