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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03599674
Other study ID # STUDY00000852
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date October 29, 2018

Study information

Verified date June 2021
Source Seattle Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 29, 2018
Est. primary completion date October 19, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Seattle Children's Hospital Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Local system navigation 9 items assessing familiarity with navigating the local health care system. Enrollment and 2-4 weeks after discharge.
Secondary Communication--Pediatric H-CAHPS 9 items assessing quality of communication from doctors and nurses, including at discharge. 2-4 weeks after discharge.
Secondary Partnership--Pediatric H-CAHPS 3 items assessing provider-family partnership. 2-4 weeks after discharge.
Secondary Health care transition questions 10 items assessing quality of transition and comfort and understanding of home care. 2-4 weeks after discharge.
Secondary Unmet need for navigation 7 items to determine whether family's needs were identified and met during hospitalization 2-4 weeks after discharge.
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