Active — Not RecruitingNot Applicable

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

United States87 participantsStarted 2024-06-25

Plain-language summary

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.

Who can participate

Age range35 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Timeframe: Baseline, Month 12

Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

Timeframe: Baseline, Month 12

Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)

Timeframe: Baseline, Month 12

Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use

Timeframe: Baseline, Month 12

Change in Ethanol Glucuronide (ETG) Levels

Timeframe: Baseline, Month 12

Change in Phosphatidylethanol (PeTH) Levels

Timeframe: Baseline, Month 12

Change in CDC HIV Incidence Risk Index Score

Timeframe: Baseline, Month 12

Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score

Timeframe: Baseline, Month 12

Trial details

NCT IDNCT05828849

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Cardiovascular Disease trials

Plain-language summary

Who can participate

Age range35 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in Alcohol Use Disorders Identification Test (AUDIT) Score

Timeframe: Baseline, Month 12

Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)

Timeframe: Baseline, Month 12

Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)

Timeframe: Baseline, Month 12

Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use

Timeframe: Baseline, Month 12

Change in Ethanol Glucuronide (ETG) Levels

Timeframe: Baseline, Month 12

Change in Phosphatidylethanol (PeTH) Levels

Timeframe: Baseline, Month 12

Change in CDC HIV Incidence Risk Index Score

Timeframe: Baseline, Month 12

Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score

Timeframe: Baseline, Month 12