Clinical trial NCT05828849: Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Disease
Alcohol Use Disorder
HIV Risk
Substance Use Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age 35 to 64
2. Low SES (≤ $38,000 annual income, based on 2019 20th percentile NYC income, adjusted for family size)
3. Expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors:

   1. 10-year cardiovascular risk ≥10% (assessed by ASCVD risk tool)
   2. 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)
4. Willing to be navigated to Health and Hospitals Corporation of New York health system.
5. Ability to provide written informed consent in English or Spanish

Exclusion Criteria:

1. Receives regular care elsewhere than Health and Hospitals Corporation of New York
2. Already diagnosed with high mortality-condition(s) that are not included in the simulation model.

Primary outcomes:
measure: Change in Alcohol Use Disorders Identification Test (AUDIT) Score
timeFrame: Baseline, Month 12
measure: Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
timeFrame: Baseline, Month 12
measure: Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)
timeFrame: Baseline, Month 12
measure: Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use
timeFrame: Baseline, Month 12
measure: Change in Ethanol Glucuronide (ETG) Levels
timeFrame: Baseline, Month 12
measure: Change in Phosphatidylethanol (PeTH) Levels
timeFrame: Baseline, Month 12
measure: Change in CDC HIV Incidence Risk Index Score
timeFrame: Baseline, Month 12
measure: Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score
timeFrame: Baseline, Month 12
measure: Mean Systolic Blood Pressure
timeFrame: Up to Month 12
measure: Mean Diastolic Blood Pressure
timeFrame: Up to Month 12
measure: Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC H+H/Bellevue
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ronald S Braithwaite, Braithwaite
role: PRINCIPAL_INVESTIGATOR
References: