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临床试验/NCT02451059
NCT02451059已完成不适用

Reducing Socioeconomic Disparities in Health at Pediatric Visits

Boston Medical Center6 个研究点 分布在 1 个国家目标入组 1,205 人开始时间: 2015年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,205
试验地点
6
主要终点
Health care utilization

研究概览

简要总结

This research project is aimed to assess the effectiveness and impact of a pediatric-based intervention aimed at reducing low-income families' unmet material needs (food, housing, employment, childcare, household heat, education and learning the English language ) on child health.

详细描述

This project builds upon the PI's prior studies including a recently completed cluster randomized controlled trial (RCT) at community health centers in Boston, which demonstrated a positive impact on provider referrals, discussion, and family receipt of resources.

This study will specifically test the effectiveness of a further strengthened intervention "WE CARE 2.0" on provider referrals and family receipt of resources, along with its impact on child health, health care utilization, and developmental outcomes. Finally, we will gather information from stakeholders at the health centers in order to learn more about the facilitators and barriers to implementation of the model.

The study will take place at six community health centers in the Greater Boston area. The centers will be randomized to either an intervention or control site. Data will be collected on referrals, receipt of resources, and child outcomes from the child's electronic medical record (EMR) from birth to age 3. Focus groups will be used to gather implementation data from intervention health center personnel.

The WE CARE 2.0 intervention consists of: 1) WE CARE surveys which parents complete prior to their child's well-child visits; 2) information technology (IT) generated provider referrals which providers use to provide families with resource information sheets; 3) peer patient navigators who assist families in connecting to available resources and updating providers; and 4) training sessions for providers and office staff.

Families attending the control health centers will receive standard of care. Of note, since the health centers share a common EMR and for ethical reasons, control sites will have access to the IT generated referral mechanism.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 1 Month(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Child is on Medicaid insurance
  • •Is attending routine newborn visit

排除标准

  • •Premature (less than or equal to 32 weeks GA)
  • •Has a chronic disease
  • •Has Neonatal Abstinence Syndrome
  • •Has a foster parent

研究组 & 干预措施

Intervention-WE CARE

Experimental
  1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age.
  2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR.
  3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets.

干预措施: WE CARE survey (Behavioral)

Intervention-WE CARE

Experimental
  1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age.
  2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR.
  3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets.

干预措施: WE CARE Community Resource Handout (Behavioral)

Intervention-WE CARE

Experimental
  1. The WE CARE survey is used to identify unmet material needs; it will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age.
  2. Providers will be trained to review the WE CARE survey at health supervision visits and generate our WE CARE community resource handouts (referrals) through the EMR.
  3. A peer patient navigator will offer personalized guidance to families with accessing community resources. The patient navigator will be available for at least a 1/2 day per week at each intervention health center to meet with families and offer guidance. Providers can communicate the patient navigator to refer families via the electronic medical record and families will also have the opportunity to contact the peer navigator at any time via the hotline number listed on the referral information sheets.

干预措施: Patient Navigator (Behavioral)

Control-Standard of Care

No Intervention

Participants in the delayed-intervention control group will receive standard pediatric care. However, since the health centers share a common EMR, and for ethical reasons, investigators will also embed the health IT referral mechanism into the EMR at the control sites. Control providers will be made aware of this prior to the start of the study. Although this may potentially reduce the effect size, the investigator's prior study found that the impact on referral rates of provider access to resource information was minimal. Families at control health centers will not receive the WE CARE surveys at health supervision visits and will not have access to the peer patient navigators

结局指标

主要结局

Health care utilization

时间窗: Throughout child's enrollment in study (0 years through 3 years of age)

Investigators will measure whether child is up to date with well child visits between 0-3 years of age. Investigators will measure whether child is up to date on their immunizations between 0-3 years of age. Investigators will measure if and how many times child has been hospitalized or had a visit to the emergency department (ED) between 0-3 years of age.

次要结局

  • Family receipt of community based resource(Throughout child's enrollment in study (0 years through 3 years of age))
  • Provider referrals(Throughout child's enrollment in study (0 years through 3 years of age))
  • Developmental delay(Throughout child's enrollment in study (0 years through 3 years of age))
  • Asthma(Throughout child's enrollment in study (0 years through 3 years of age))
  • Obesity(Measured at 2-year, 30-month, and 3-year well child care visits (as recommended by the American Academy of Pediatrics))
  • Blood pressure(Measured at 3-year well child care visits)
  • Focus group data gathered by audio recordings then transcribed and coded(During 1st month pilot phase and again after investigators have enrolled our the cohort, approximately 3 years after the first focus groups and the study initiation)
  • Child maltreatment(Throughout child's enrollment in study (0 years through 3 years of age))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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