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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05828849
• Other study ID #: 22-01584
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Ronald S Braithwaite, MD
• Phone: 212-263-4964
• Email: Scott.Braithwaite[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Cardiovascular Disease
• Cardiovascular Diseases
• HIV Risk
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Navigation, compensation, and personalization
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.

Locations

Country	Name	City	State
United States	NYC H+H/Bellevue	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Ethanol Glucuronide (ETG) Levels	ETG (ng/ml) will be measured via urine test.	Baseline, Month 12
Primary	Change in Phosphatidylethanol (PeTH) Levels	PeTH (ng/ml) will be measured via blood test.	Baseline, Month 12
Primary	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
Primary	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
Primary	Mean Systolic Blood Pressure		Up to Month 12
Primary	Mean Diastolic Blood Pressure		Up to Month 12
Primary	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