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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Change in Ethanol Glucuronide (ETG) Levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Low SES Population - Intervention
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.
干预措施: Navigation, compensation, and personalization (Behavioral)
Low SES Population - 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.
结局指标
主要结局
Change in Ethanol Glucuronide (ETG) Levels
时间窗: Baseline, Month 12
ETG (ng/ml) will be measured via urine test.
Change in 2-Week Timeline Follow-Back (TLFB) for Alcohol Use
时间窗: Baseline, Month 12
The TLFB allows participants to indicate how many drinks they have had over the previous two weeks.
Change in Alcohol Use Disorders Identification Test (AUDIT) Score
时间窗: Baseline, Month 12
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)
时间窗: Baseline, Month 12
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)
时间窗: Baseline, Month 12
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.
Mean Systolic Blood Pressure
时间窗: Up to Month 12
Change in Phosphatidylethanol (PeTH) Levels
时间窗: Baseline, Month 12
PeTH (ng/ml) will be measured via blood test.
Change in CDC HIV Incidence Risk Index Score
时间窗: Baseline, Month 12
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
时间窗: Baseline, Month 12
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 Diastolic Blood Pressure
时间窗: Up to Month 12
Percent Change in Participants Determined to be "High-Risk" for SUD per TAPS Screening Tool
时间窗: Baseline, Month 12
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.
次要结局
未报告次要终点