NCT03599674

Brief Summary

The overall goal of this research is to evaluate a new program designed to address basic human needs, create a safe and supportive environment for families, and help families build skills and confidence for navigating the health care system. Specifically, we aim to pilot test the feasibility and acceptability of the Targeted Inpatient Navigation (TNav) program for families of low income, minority hospitalized children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2018

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2018

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 4, 2018

Last Update Submit

June 22, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Program acceptability to caregivers--qualitative

    Program acceptability will be determined qualitatively, on the basis of thematic content analysis of semi-structured interviews with enrolled caregivers

    4-6 weeks after discharge

  • Program feasibility

    Ability to deliver program elements as planned, calculated as the number of Family Bridge services delivered to a family divided by the services available to that family.

    Calculated for each family after program involvement is complete, generally 1 week after discharge.

  • Program acceptability to providers--qualitative

    Program acceptability will be determined qualitatively, on the basis of thematic content analysis of semi-structured interviews with the doctors, nurses, social workers and care coordinators who were involved in their hospital care.

    Once per month, every month that they care for an enrolled family, up to 6 months

Secondary Outcomes (9)

  • Cultural Distance Scale

    Enrollment and 2-4 weeks after discharge.

  • Barriers to Care Questionnaire

    Enrollment and 2-4 weeks after discharge.

  • Perceived Efficacy in Patient-Physician Interactions (PEPPI)

    Enrollment and 2-4 weeks after discharge.

  • Perceived Stress Scale-short form

    Enrollment and 2-4 weeks after discharge.

  • Local system navigation

    Enrollment and 2-4 weeks after discharge.

  • +4 more secondary outcomes

Study Arms (1)

Family Bridge Program

EXPERIMENTAL

Families receive Family Bridge Program services which include orientation to the hospital, concrete needs assessment, communication preferences assessment, communication coaching, follow-up during the hospital stay, and a follow-up phone call after discharge.

Behavioral: Family Bridge Program

Interventions

Families receive Family Bridge Program services which include orientation to the hospital, concrete needs assessment, communication preferences assessment, communication coaching, follow-up during the hospital stay, and a follow-up phone call after discharge.

Family Bridge Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver ≥18 years of age, with a hospitalized child \<18 years old
  • Preferred language of English, Spanish and Somali
  • child with Medicaid insurance or no insurance
  • child with self-reported (or parent-reported) minority race/ethnicity
  • within 3 days of admission/ transfer to the medical unit on a general medicine service of a resident team

You may not qualify if:

  • Admission for suspected child abuse
  • Involvement of Child Protective Services at time of admission
  • Admission for primary mental health condition, including intentional ingestion and eating disorder
  • Family already enrolled in longer-term navigation services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • Lion KC, Arthur KC, Frias Garcia M, Hsu C, Sotelo Guerra LJ, Chisholm H, Griego E, Ebel BE, Penfold RB, Rafton S, Zhou C, Mangione-Smith R. Pilot Evaluation of the Family Bridge Program: A Communication- and Culture-Focused Inpatient Patient Navigation Program. Acad Pediatr. 2024 Jan-Feb;24(1):33-42. doi: 10.1016/j.acap.2023.06.021. Epub 2023 Jun 22.

  • Chisholm H, Kershaw T, Sotelo Guerra L, Bocek K, Garcia Y, Lion KC. A Realist Evaluation Analysis of a Novel Multi-Faceted Inpatient Patient Navigation Program. Acad Pediatr. 2022 Jul;22(5):789-796. doi: 10.1016/j.acap.2021.09.009. Epub 2021 Sep 20.

Study Officials

  • K.Casey Lion, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator | Center for Child Health, Behavior and Development

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 26, 2018

Study Start

April 16, 2018

Primary Completion

October 19, 2018

Study Completion

October 29, 2018

Last Updated

June 25, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations