Clinical trial NCT04771650: A Hybrid Effectiveness Implementation Study of Latino/a Alcohol and Drug Users
Official title: Addressing Alcohol-Use Related Health Disparities: A Hybrid Effectiveness Implementation Study of a Culturally Adapted MI for Latino/a Alcohol and Drug Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Drug Use
Psychological Distress
Keywords: Alcohol
Drug
Latinx
Treatment
Psychological distress
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institutes of Health (NIH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2021-02-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical effectiveness trial that tests two conditions (CAMI plus booster + standard care compared to assessment + standard care). Health outcomes are reduced drinking, related harms and improvement of mental health. Follow-up at 3,6, and 12 months.
Primary purpose: TREATMENT

Brief summary: Alcohol use is a significant problem among Latinxs and immigration-related stress increases risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of immigration-related stressors (e.g., stigma, social isolation) resulted in significant reductions in alcohol-related harms for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious addiction interventions are not common, yet are needed to advance implementation science. This Hybrid Type 1 Effectiveness-Implementation study will investigate the feasibility of implementing CAMI in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus a booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol-related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from this Hybrid study to the broader community to focus on population health for all primary care patients.

Detailed description: Alcohol use is a significant problem among Latinxs because of the disproportionate burden of physical harms and negative consequences associated with substance use relative to other racial/ethnic groups. Factors associated with the stress related to being an immigrant increase risk for substance use. A theoretically-based cultural adaptation of motivational interviewing (CAMI) that specifically integrated discussion of stressors related to immigration (e.g., discrimination, stigma, social isolation) resulted in significant reductions in harms related to alcohol for those Latinx heavy drinkers with high discrimination compared to standard MI, and reduced anxiety and depressive symptoms one year later compared to MI. Rigorous tests that examine theoretically-informed adaptation of efficacious interventions for addictions are not common, yet are needed to advance implementation science because they address questions that are the basis for successful implementation. The proposed Hybrid Type 1 Effectiveness-Implementation study is an important next step in this line of research, which is to investigate the feasibility of implementing the CAMI intervention in a real-world clinical setting. The key questions are: Would CAMI have positive effects among individuals who use both drugs and alcohol? How do providers view this intervention? The investigators will collaborate with a primary care center that serves a mainly Latinx client population to train their Community Wellness Advocates (CWAs) to deliver the CAMI to patients who are heavy drinkers. The investigators will conduct a concurrent investigation on the process of implementing the CAMI in primary care - a two-arm randomized clinical effectiveness trial will enroll Latinx heavy drinkers (18 years or older) in primary care who use alcohol (and may use other drugs) - and follow them for 12 months after the intervention. Specific Aims are: (1) To examine the impact of CAMI plus an in- person booster session (vs. assessment only) on outcomes: % heavy drinking days, frequency of alcohol- related consequences, depressive/anxiety symptoms, and number of illicit drug use days, using a Hybrid Type 1 Effectiveness-Implementation design and (2) To gather indicators of implementation outcome from multiple stakeholders using a mixed-methods approach. The investigators will follow Curran's framework to evaluate the process of implementation and Proctor's framework to measure implementation outcomes: acceptability, adoption, intervention appropriateness, feasibility, overall cost (i.e., CAMI vs. assessment only), and treatment fidelity. This study, a first to examine the acceptability of culturally-adapted addiction treatments in primary care settings, will answer essential questions on implementing evidence-based care for Latinxs that can improve health disparities related to substance use. Long term goals are to translate the lessons from the proposed Hybrid study to the broader community to focus on population health for all primary care patients.

Eligibility criteria: Inclusion Criteria:

* Meets criteria for binge drinking in the past month (\> 4/5 (females/males) drinks/occasion, 1+ days/month)
* Age 18 or older
* Identify as Latinx
* First or second-generation immigrant

Exclusion Criteria:

* Current psychotic symptoms
* Cognitive impairment
* Currently in psychosocial treatment for alcohol use disorder
* Patients who have been enrolled in the Complex Care Management (CCM) before January 1, 2021.

Primary outcomes:
measure: Percent heavy drinking days
timeFrame: 3 month follow-up
measure: Alcohol-related consequences
timeFrame: 3 month follow-up
measure: Percent drug use days
timeFrame: 3 month follow-up
Secondary outcomes:
measure: Percent heavy drinking days
timeFrame: 6 month follow-up
measure: Percent heavy drinking days
timeFrame: 12 month follow-up
measure: Alcohol-related consequences
timeFrame: 6 month follow-up
measure: Alcohol-related consequences
timeFrame: 12 month follow-up
measure: Center for Epidemiological Studies - Depression
timeFrame: 3 month follow-up
measure: Center for Epidemiological Studies - Depression
timeFrame: 6 month follow-up
measure: Center for Epidemiological Studies - Depression
timeFrame: 12 month follow-up
measure: Beck Anxiety Inventory
timeFrame: 3 month follow-up
measure: Beck Anxiety Inventory
timeFrame: 6 month follow-up
measure: Beck Anxiety Inventory
timeFrame: 12 month follow-up
measure: Percent drug use days
timeFrame: 6 month follow-up
measure: Percent drug use days
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Mercy Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Christina S Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee CS, Colby SM, Magill M, Almeida J, Tavares T, Rohsenow DJ. A randomized controlled trial of culturally adapted motivational interviewing for Hispanic heavy drinkers: Theory of adaptation and study protocol. Contemp Clin Trials. 2016 Sep;50:193-200. doi: 10.1016/j.cct.2016.08.013. Epub 2016 Aug 24.
citation: Lee CS, Colby SM, Rohsenow DJ, Martin R, Rosales R, McCallum TT, Falcon L, Almeida J, Cortes DE. A randomized controlled trial of motivational interviewing tailored for heavy drinking latinxs. J Consult Clin Psychol. 2019 Sep;87(9):815-830. doi: 10.1037/ccp0000428.