The Effect of a Clinic-Based Financial Coaching on Health and Development
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
研究概览
简要总结
This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net.
详细描述
With an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.We will conduct a clinical randomized controlled trial of financial coaching for low-income families. Parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for five years. Aims include:
1a) Examine parent outcomes of overall health-related quality of life (primary parent outcome);
1b) Examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence;
1c) Examine family social needs outcomes, including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more) and resource use; and financial metrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Pediatricians and outcomes assessors will not be aware of study arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.
排除标准
- •Cognitive impairment or not speaking English or Spanish.
研究组 & 干预措施
Intervention - Financial Coaching Plus Social Needs Screening
Families in this intervention arm will receive financial coaching at each well child visit, in addition to clinic-based social needs screening and referral.
干预措施: Financial coaching and services (Behavioral)
Control - Social Needs Screening and Referral
Families in this active control arm will receive social needs screening and referral to community resources to address identified social needs.
干预措施: Financial coaching and services (Behavioral)
结局指标
主要结局
Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
时间窗: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
Health-related quality of life will be measured at baseline and regular intervals using the Patient-Reported Outcomes Measurement Information System Global Health Short Form 10 (PROMIS 10). This will be the primary outcome for parents in the study. The PROMIS-10 measures overall health, physical health, mental health and social functioning and is scored on a T-scored range with 50 as the mean and 10 as the standard deviation. Higher scores indicate better HRQOL.
Developmental Risk - Ages and Stages Questionnaires
时间窗: Interval change in developmental risk will be assessed over up to a 5 year period.
Parent report of child developmental risk via clinic-based developmental questionnaires (Ages and Stages Questionnaires, ASQ) will be used to measure developmental risk. The ASQ measure contains sub-scales for each developmental domain (gross motor, fine motor, problem solving, communication, problem-solving, personal-social). Parent-reported ASQ items yield a score from 0-60 with cutoffs determining children at risk for developmental delay. Higher scores indicate less risk of developmental delay.
Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
时间窗: Interval change in presence of any social need will be assessed over up to a 5 year period.
Family social needs to be assessed at baseline and regular intervals include food insecurity, housing insecurity, transportation problems, utilities problems, and legal issues. All of these social needs are measured using the Accountable Health Communities Social Needs Screener and the presence of any of the above social needs will be interpreted as the presence of a social need. Social needs resource use will also be measured.
Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
时间窗: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
Health-related quality of life will be measured at baseline and regular intervals using the Patient-Reported Outcomes Measurement Information System Global Health Short Form 10 (PROMIS 10). This will be the primary outcome for parents in the study. The PROMIS-10 measures overall health, physical health, mental health and social functioning and is scored on a T-scored range with 50 as the mean and 10 as the standard deviation. Higher scores indicate better HRQOL.
Developmental Risk - Ages and Stages Questionnaires
时间窗: Interval change in developmental risk will be assessed over up to a 5 year period.
Parent report of child developmental risk via clinic-based developmental questionnaires (Ages and Stages Questionnaires, ASQ) will be used to measure developmental risk. The ASQ measure contains sub-scales for each developmental domain (gross motor, fine motor, problem solving, communication, problem-solving, personal-social). Parent-reported ASQ items yield a score from 0-60 with cutoffs determining children at risk for developmental delay. Higher scores indicate less risk of developmental delay.
Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
时间窗: Interval change in presence of any social need will be assessed over up to a 5 year period.
Family social needs to be assessed at baseline and regular intervals include food insecurity, housing insecurity, transportation problems, utilities problems, and legal issues. All of these social needs are measured using the Accountable Health Communities Social Needs Screener and the presence of any of the above social needs will be interpreted as the presence of a social need. Social needs resource use will also be measured.
次要结局
- Economic Stress - Family Economic Strain Scale.(Interval change in FESS will be assessed over up to a 5 year period.)
- Parenting Self-Efficacy - Parenting Sense of Competence Scale(Interval change in PSOC will be assessed over up to a 5 year period.)
- Pediatric Primary Care Visit Adherence(Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.)
研究者
Adam Schickedanz
Assistant Professor of Pediatrics
University of California, Los Angeles