Family Bridge Program Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 728
- 试验地点
- 2
- 主要终点
- System Navigation Ability
研究概览
简要总结
Pediatric healthcare disparities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address disparities related to communication and system navigation in the inpatient setting; given the established links between these and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a diverse population of children and their families, The Family Bridge Program (FBP).
The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.
In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children from families who identify as Hispanic, Black, Asian, Native American/Alaska Native, or Pacific Islander. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children at risk for disparities, including those who prefer a language other than English for their medical care.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents/guardians Inclusion Criteria:
- •At least 18 years old; there is no maximum age;
- •The legal guardian of an eligible child
- •Prefer English, Spanish, Somali or Vietnamese for medical care
- •Children Inclusion Criteria:
- •Under 18 years of age at enrollment; there is no minimum age
- •Admitted to a general pediatric service at a participating hospital
- •Have been admitted within the past 4 days
- •Have public or no insurance (as a proxy for low income)
- •Have a self- or parent-reported race/ethnicity other than only non-Hispanic white
- •Parents/guardians
排除标准
- •Children Exclusion Criteria:
- •Not already be enrolled in long-term care coordination or patient services navigation
- •Not have an admitting diagnosis that is primarily psychiatric (e.g., anorexia nervosa, suicide attempt)
- •Not be admitted for suspicion for child abuse.
研究组 & 干预措施
Care as Usual- Resources Only
干预措施: Care as usual - resources only (Behavioral)
Family Bridge Program
干预措施: Family Bridge Program (Behavioral)
结局指标
主要结局
System Navigation Ability
时间窗: Enrollment and 2-6 weeks after discharge
Change score -100 to 100, based on 10-item measure of parent self-reported ability to navigate the healthcare system (e.g., ability to schedule appointments or ask questions). Each response of Yes (100), Sometimes (50), or No (0) is averaged to create overall score. Change score as difference from enrollment to follow-up
Pediatric Transition Experience Measure (P-TEM)
时间窗: 2-6 weeks after discharge
Percent of items with "top-box" score, based on the Pediatric Transition Experience Measure (P-TEM), an 8-item measure to assess hospital-to-home transition. Responses are on Likert scale from 0 to 5, with top-box scoring for overall measure.
次要结局
- Diagnosis Comprehension(2-6 weeks after discharge)
- Perceived Stress Scale(2-6 weeks after discharge)
- 30-day readmissions(30 days after discharge from index hospital stay)
- Observed Communication: utterances in which team offers information(Day 1-5 of hospital admission)
- Observed Communication: utterances in which team offers supportive talk(Day 1-5 of hospital admission)
- Observed Communication: utterances in which parent asks questions(Day 1-5 of hospital admission)
- Observed Communication: utterances in which parent responds assertively(Day 1-5 of hospital admission)
- Observed Communication: parent talk-time(Day 1-5 of hospital admission)
- Observed Communication: global partnership rating(Day 1-5 of hospital admission)
研究者
K. Casey Lion
Principal Investigator
Seattle Children's Hospital
