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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low SES Population - Intervention | Experimental | 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. |
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| Low SES Population - No Intervention | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation, compensation, and personalization | Behavioral | 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. |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald S Braithwaite, Braithwaite | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYC H+H/Bellevue | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2023 | Jan 14, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000437 | Alcoholism |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D035881 | Compensation and Redress |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D007603 | Jurisprudence |
| D012926 | Social Control, Formal |
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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:
| 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 |