Hospitalized ChildrenTNavNCT03599674
Targeted Inpatient Navigation to Improve Care for Minority Children and Families
A study testing Family Bridge Program in people with Hospitalized Children, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Children
- What is being tested?
- Family Bridge Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 29 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
- Conditions
- Hospitalized Children
- Being tested
- Family Bridge Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Bridge ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Family Bridge Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Once per month, every month that they care for an enrolled family, up to 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Enrollment and 2-4 weeks after discharge.
Local system navigation
9 items assessing familiarity with navigating the local health care system.
Measured: Enrollment and 2-4 weeks after discharge.
Communication--Pediatric H-CAHPS
9 items assessing quality of communication from doctors and nurses, including at discharge.
Measured: 2-4 weeks after discharge.
Partnership--Pediatric H-CAHPS
3 items assessing provider-family partnership.
Measured: 2-4 weeks after discharge.
Health care transition questions
10 items assessing quality of transition and comfort and understanding of home care.
Measured: 2-4 weeks after discharge.
Unmet need for navigation
7 items to determine whether family's needs were identified and met during hospitalization
Measured: 2-4 weeks after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start16 Apr 2018
- Primary completion19 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hospitalized ChildrenStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Casey Lion, Seattle Children's Hospital
- Investigators
- K.Casey Lion, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599674
- Sponsor's protocol ID
- STUDY00000852
- Acronym
- TNav
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2018
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37354947Chisholm 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.
PubMed 34551342
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Inpatient Navigation to Improve Care for Minority Children and Families
- ClinicalTrials.gov ID
- NCT03599674
- Acronym / sponsor ID
- TNav / STUDY00000852
- Conditions
- Hospitalized Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Bridge Program | Experimental | Behavioral: Family Bridge ProgramFamilies 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Bridge ProgramFamilies 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. | Behavioural | Family Bridge Program |
Primary outcome
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
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.
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.
9 secondary outcomes
Cultural Distance Scale
Time frame: Enrollment and 2-4 weeks after discharge.
Barriers to Care Questionnaire
Time frame: Enrollment and 2-4 weeks after discharge.
Perceived Efficacy in Patient-Physician Interactions (PEPPI)
Time frame: Enrollment and 2-4 weeks after discharge.
Perceived Stress Scale-short form
Time frame: Enrollment and 2-4 weeks after discharge.
Local system navigation
Time frame: Enrollment and 2-4 weeks after discharge.
Communication--Pediatric H-CAHPS
Time frame: 2-4 weeks after discharge.
Partnership--Pediatric H-CAHPS
Time frame: 2-4 weeks after discharge.
Health care transition questions
Time frame: 2-4 weeks after discharge.
Unmet need for navigation
Time frame: 2-4 weeks after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Derived from this study: PubMed 37354947Lion 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.
- Derived from this study: PubMed 34551342Chisholm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K.Casey Lion, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Bridge Program in people with Hospitalized Children, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program acceptability to caregivers--qualitative (time frame: 4-6 weeks after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599674, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.