Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

Study Overview
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Brief Summary
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The purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, HIV, and other conditions.

Official Title
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Can a Radical Transformation of Preventive Care Reduce Mortality by 20% in Low Socioeconomic (SES) Populations? Preparatory Work Focusing on Alcohol Use Disorder (AUD)/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk

Conditions
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Cardiovascular Disease, Alcohol Use Disorder, HIV Risk, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Navigation, compensation, and personalization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 35 to 64 Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size) Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors: 10-year cardiovascular risk ≥10% (assessed by ASCVD risk tool) Heavy alcohol consumption (defined using SAMHSA binge drinking definition, drinking >4 standard drinks for men and >3 standard drinks for women on same occasion in past month) Willing to be navigated to Health and Hospitals Corporation of New York health system. Ability to provide written informed consent in English or Spanish Exclusion Criteria: Receives regular care elsewhere than Health and Hospitals Corporation of New York Already diagnosed with high mortality-condition(s) that are not included in the simulation model.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low SES Population - Intervention<br>Participants receive the study intervention, composed of navigation, compensation, and personalization for study participants. The intervention will be administered in person to the participants recruited for the study and will be administered by peer navigators who will be trained on Motivational Interviewing (MINT) techniques. | Behavioral: Navigation, compensation, and personalization<br>* The study intervention is composed of navigation, compensation, and personalization. Navigation refers to reducing barriers posed by fragmentation of health and social systems. Compensation refers to reimbursement of out-of-pocket expenses to offset dependent care, time costs, and travel expenditures necessary to access care for the different conditions and goals of the intervention. Personalization refers to preventative interventions that are personalized based on individual for potential benefit.<br>|
| No Intervention: Low SES Population - No Intervention<br>Participants receive no intervention components of navigation, compensation, and personalization. Participants will receive their normal medical care through regular doctor visits without any intervention or personalization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alcohol Use Disorders Identification Test (AUDIT) Score | 10-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-40; higher scores indicate it is more likely the patient's drinking is affecting their health and safety. | Baseline, Month 12 | 
| Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C) | 4-item self-assessment of alcohol use disorders. Items are rated on a scale from 0 to 4. The total score is the sum of responses and ranges from 0-12; higher scores indicate it is more likely the patient's drinking is affecting their health and safety. | Baseline, Month 12 | 
| Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1) | The NIAAA-1 asks participants how many times in the past year they have had four or more drinks (for females) or five or more drinks (for males) in a day. The responses are 0 (never), 1 (Less than once a month), 2 (One to three times per month), 3 (One to three times per week) and 4 (More than three times per week). The total score is the item response and ranges from 0-4; higher scores indicate greater unhealthy alcohol use. | Baseline, Month 12 | 
| Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use | The TLFB allows participants to indicate how many drinks they have had over the previous two weeks. | Baseline, Month 12 | 
| Change in Ethanol Glucuronide (ETG) Levels | ETG (ng/ml) will be measured via urine test. | Baseline, Month 12 | 
| Change in Phosphatidylethanol (PeTH) Levels | PeTH (ng/ml) will be measured via blood test. | Baseline, Month 12 | 
| Change in CDC HIV Incidence Risk Index Score | 3-item assessment of HIV risk among people who inject drugs. The total score ranges from 0 to 100; higher scores indicate greater risk of HIV. | Baseline, Month 12 | 
| Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score | The AHA/ACC Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator is a questionnaire that uses responses to calculate the lifetime risk of ASCVD as a percentage (0%-100%); higher percentages indicate greater lifetime risk of ASCVD. The percentages are classified as follows: Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%) | Baseline, Month 12 | 
| Mean Systolic Blood Pressure |  | Up to Month 12 | 
| Mean Diastolic Blood Pressure |  | Up to Month 12 | 
| Percent Change in Participants Determined to be High-Risk for SUD per TAPS Screening Tool | The Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool is used to assess primary care patients for tobacco, alcohol, prescription drug, and illicit substance use and problems related to their use. Based on patient responses, the tool classifies the patient risk levels as High Risk, Problem Use, Undetermined Risk and Minimal Risk. This outcome measures the percent change in participants determined to be High Risk for substance abuse disorder (SUD) from baseline to Month 12. | Baseline, Month 12 |