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Completed

NCT Number: NCT03599674

Targeted Inpatient Navigation to Improve Care for Minority Children and Families

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.

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Key information

Conditions

Hospitalized Children

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Bridge Program

Behavioral

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.

Primary outcomes

  1. Program acceptability to caregivers--qualitative

    Time frame: 4-6 weeks after discharge

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

  2. Program feasibility

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

    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.

  3. Program acceptability to providers--qualitative

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

    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.

Secondary outcomes

  1. Cultural Distance Scale

    Time frame: Enrollment and 2-4 weeks after discharge.

    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.

  2. Barriers to Care Questionnaire

    Time frame: Enrollment and 2-4 weeks after discharge.

    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.

  3. Perceived Efficacy in Patient-Physician Interactions (PEPPI)

    Time frame: Enrollment and 2-4 weeks after discharge.

    10-item tool measuring understanding of and ability to interact with health professionals and organizations.

  4. Perceived Stress Scale-short form

    Time frame: Enrollment and 2-4 weeks after discharge.

    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.

  5. Local system navigation

    Time frame: Enrollment and 2-4 weeks after discharge.

    9 items assessing familiarity with navigating the local health care system.

  6. Communication--Pediatric H-CAHPS

    Time frame: 2-4 weeks after discharge.

    9 items assessing quality of communication from doctors and nurses, including at discharge.

  7. Partnership--Pediatric H-CAHPS

    Time frame: 2-4 weeks after discharge.

    3 items assessing provider-family partnership.

  8. Health care transition questions

    Time frame: 2-4 weeks after discharge.

    10 items assessing quality of transition and comfort and understanding of home care.

  9. Unmet need for navigation

    Time frame: 2-4 weeks after discharge.

    7 items to determine whether family's needs were identified and met during hospitalization

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Acronym: TNav

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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