Back to resultsMortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
Primary Purpose
Cardiovascular Disease, Alcohol Use Disorder, HIV Risk
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Navigation, compensation, and personalization
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease
Eligibility Criteria
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.
Sites / Locations
- NYC H+H/Bellevue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Low SES Population - Intervention
Low SES Population - No Intervention
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Change in Ethanol Glucuronide (ETG) Levels
ETG (ng/ml) will be measured via urine test.
Change in Phosphatidylethanol (PeTH) Levels
PeTH (ng/ml) will be measured via blood test.
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.
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%)
Mean Systolic Blood Pressure
Mean Diastolic Blood Pressure
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05828849
First Posted
April 13, 2023
Last Updated
April 13, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT05828849
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Alcohol Use Disorder, HIV Risk, Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low SES Population - Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Low SES Population - No Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Navigation, compensation, and personalization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
Description
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.
Time Frame
Baseline, Month 12
Title
Change in Alcohol Use Disorders Identification Test-Concise (AUDIT-C)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in National Institute on Alcohol Abuse and Alcoholism (NIAAA) single-item alcohol use screen (NIAAA-1)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use
Description
The TLFB allows participants to indicate how many drinks they have had over the previous two weeks.
Time Frame
Baseline, Month 12
Title
Change in Ethanol Glucuronide (ETG) Levels
Description
ETG (ng/ml) will be measured via urine test.
Time Frame
Baseline, Month 12
Title
Change in Phosphatidylethanol (PeTH) Levels
Description
PeTH (ng/ml) will be measured via blood test.
Time Frame
Baseline, Month 12
Title
Change in CDC HIV Incidence Risk Index Score
Description
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.
Time Frame
Baseline, Month 12
Title
Change in American Heart Association/American College of Cardiology (AHA/ACC) ASCVD Risk Calculator Score
Description
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%)
Time Frame
Baseline, Month 12
Title
Mean Systolic Blood Pressure
Time Frame
Up to Month 12
Title
Mean Diastolic Blood Pressure
Time Frame
Up to Month 12
Title
Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool
Description
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.
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald S Braithwaite, MD
Phone
212-263-4964
Email
Scott.Braithwaite@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Feelemyer
Phone
301-379-9341
Email
Jonathan.Feelemyer@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald S Braithwaite, Braithwaite
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYC H+H/Bellevue
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Dr. Ronald Scott Braithwaite, Scott.Braithwaite@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Scott.Braithwaite@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Mortality Reductions Based on AUD/Heavy Alcohol Use, HIV Risk, and Cardiovascular Risk
We'll reach out to this number within 24 hrs