Targeted Inpatient Navigation to Improve Care for Minority Children and Families (TNav)

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.

Study Overview

• Status: Completed
• Conditions: Hospitalized Children
• Intervention / Treatment: Behavioral: Family Bridge Program

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Bridge Program; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cultural Distance Scale	4 items measuring perceived similarity or difference in norms and values between family and medical providers. Each of the 4 items is scored on a Likert scale from 1 to 6, with higher values reflecting greater difference. The total scale score is the average of the 4 responses, on a scale from 1 to 6.	Enrollment and 2-4 weeks after discharge.
Barriers to Care Questionnaire	20 items measuring perceived barriers to medical care, with 4 sub-scales, each scored and reported separately: System as a whole, Skills barriers, Expectation barriers, and Knowledge barriers. Each subscale was scored 0-100, with higher scores indicating greater barriers.	Enrollment and 2-4 weeks after discharge.
Perceived Efficacy in Patient-Physician Interactions (PEPPI)	10-item tool measuring understanding of and ability to interact with health professionals and organizations.	Enrollment and 2-4 weeks after discharge.
Perceived Stress Scale-short form	4 items, scored from 0 (Never) to 4 (Very Often), related to perceived stress and control over one's life. Responses are summed for a total score from 0 to 16, with higher scores reflecting greater stress.	Enrollment and 2-4 weeks after discharge.
Local system navigation	9 items assessing familiarity with navigating the local health care system.	Enrollment and 2-4 weeks after discharge.
Communication--Pediatric H-CAHPS	9 items assessing quality of communication from doctors and nurses, including at discharge.	2-4 weeks after discharge.
Partnership--Pediatric H-CAHPS	3 items assessing provider-family partnership.	2-4 weeks after discharge.
Health care transition questions	10 items assessing quality of transition and comfort and understanding of home care.	2-4 weeks after discharge.
Unmet need for navigation	7 items to determine whether family's needs were identified and met during hospitalization	2-4 weeks after discharge.

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: K.Casey Lion, MD, MPH, Seattle Children's Research Institute

Publications and helpful links

General Publications

• 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 record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): October 19, 2018
• Study Completion (Actual): October 29, 2018

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No