General Pediatric Medical ConditionsNCT06276621
Family Bridge Program
A study testing Family Bridge Program and Care as usual - resources only in people with General Pediatric Medical Conditions and Healthcare System Navigation, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
Pediatric healthcare disparities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and the complexity of the health system… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- General Pediatric Medical Conditions, Healthcare System Navigation, Patient-provider Communication
- What is being tested?
- Family Bridge Program and Care as usual - resources only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 May 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Parents/guardians Inclusion Criteria:
- At least 18 years old; there is no maximum age;
- The legal guardian of an eligible child
- Prefer English, Spanish, Somali or Vietnamese for medical care
Children Inclusion Criteria:
- Under 18 years of age at enrollment; there is no minimum age
- Admitted to a general pediatric service at a participating hospital
- Have been admitted within the past 4 days
- Have public or no insurance (as a proxy for low income)
Parents/guardians Exclusion Criteria:
- None
Children Exclusion Criteria:
- Not already be enrolled in long-term care coordination or patient services navigation
- Not have an admitting diagnosis that is primarily psychiatric (e.g., anorexia nervosa, suicide attempt)
- Not be admitted for suspicion for child abuse.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: Family Bridge Program Randomized Controlled Trial
Pediatric healthcare disparities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address disparities related to communication and system navigation in the inpatient setting; given the established links between these and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a broad population of children and their families, The Family Bridge Program (FBP).
The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.
In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children at risk for disparities, including those who prefer a language other than English for their medical care.
- Conditions
- General Pediatric Medical Conditions, Healthcare System Navigation, Patient-provider Communication, Health Disparities
- Being tested
- Family Bridge Program, Care as usual - resources only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Bridge ProgramBehavioural
The Family Bridge Program consists of 7 components, delivered by a trained lay navigator, the Guide. The program includes: (1) orientation to the hospital, unit, room, and hospital resources (e.g., toiletries, loaner phone chargers); (2)unmet social needs assessment, followed by connection to appropriate resources (e.g., food vouchers, community-based transportation); (3)communication and cultural preference assessment (eg, preferred language, comfort asking questions, and health-related cultural beliefs), which is communicated to the medical team and documented in the electronic health record;(4)communication coaching for parents/caregivers to help them clarify and practice asking questions of the medical team; (5)emotional support via daily check-ins during the hospital stay; (6)assistance with logistics ; and (7)one follow-up phone call, 2 days post-discharge, to address remaining questions and connect families to ongoing services if needed.
Care as usual - resources onlyBehavioural
Families randomized to the control arm will receive FBP written resources, which the Guide (and interpreter, as needed) will review with them over ~5-15 minutes one time. This includes information on hospital services (e.g., cafeteria coupons), community resources (e.g., food and housing support), the structure and roles of the medical team, and the daily hospital schedule. Parents will be informed that their child's nurse is available to help them.
| Study group | Role | What they receive |
|---|---|---|
| Family Bridge Program | Experimental | Not described Receives: Behavioral: Family Bridge Program |
| Care as Usual- Resources Only | Active comparator | Not described Receives: Behavioral: Care as usual - resources only |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Navigation Ability
Change score -100 to 100, based on 10-item measure of parent self-reported ability to navigate the healthcare system (e.g., ability to schedule appointments or ask questions).
Each response of Yes (100), Sometimes (50), or No (0) is averaged to create overall score. Change score as difference from enrollment to follow-up
Measured: Enrollment and 2-6 weeks after discharge
Pediatric Transition Experience Measure (P-TEM)
Percent of items with "top-box" score, based on the Pediatric Transition Experience Measure (P-TEM), an 8-item measure to assess hospital-to-home transition. Responses are on Likert scale from 0 to 5, with top-box scoring for overall measure.
Measured: 2-6 weeks after discharge
Secondary outcomes (9)
Diagnosis Comprehension
Discharge diagnosis concordance: 2 nurse coders, blinded to study arm, will code parent-reported discharge diagnosis as (2) Correct, (1) Vague/Incomplete, or (0) Wrong/not concordant, by comparing it to diagnosis abstracted from discharge summary, using standard of whether a follow-up provider would know the diagnosis based on the parent-provided information; dichotomized for analysis.
Measured: 2-6 weeks after discharge
Perceived Stress Scale
Scale score 0-16, using Perceived Stress Scale-Short Form 4-item measure; higher score indicates greater global stress and lower perceived control over it
Measured: 2-6 weeks after discharge
Observed Communication: utterances in which team offers information
Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a member of the medical team made an utterance that exchanged information with the family.
Measured: Day 1-5 of hospital admission
Observed Communication: utterances in which team offers supportive talk
Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a member of the medical team made an utterance that was directly supportive of family
Measured: Day 1-5 of hospital admission
Observed Communication: utterances in which parent asks questions
Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a parent or caregiver asks a question
Measured: Day 1-5 of hospital admission
Observed Communication: utterances in which parent responds assertively
Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting number of times in the discussion that a parent or caregiver responds to something a member of the medical team says in an assertive manner
Measured: Day 1-5 of hospital admission
Observed Communication: parent talk-time
Coding of audio-recorded communication with the medical team (on family centered rounds or similar discussion), reporting the percent of the overall discussion time during which the parent or caregiver was speaking
Measured: Day 1-5 of hospital admission
Observed Communication: global partnership rating
Likert scale rating from 1-5 of audio-recorded communication with the medical team (on family centered rounds or similar discussion), rating the overall degree of partnership between family and medical team demonstrated during the discussion
Measured: Day 1-5 of hospital admission
30-day readmissions
Readmissions to observation or inpatient status at the same hospital within 30 days of discharge from the index hospital stay
Measured: 30 days after discharge from index hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start7 May 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Pediatric Medical ConditionsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 728 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, K. Casey Lion, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276621
- Sponsor's protocol ID
- STUDY00003564
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Bridge Program Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06276621
- Acronym / sponsor ID
- STUDY00003564
- Conditions
- General Pediatric Medical Conditions, Healthcare System Navigation, Patient-provider Communication, Health Disparities
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 728 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 7 May 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 26 Feb 2024 (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.
Pediatric healthcare disparities in the United States (US) remain persistent and pervasive. Suboptimal patient-provider communication plays an important role in creating and maintaining disparate outcomes; this is compounded by mismatches between a family's skills and resources and the complexity of the health system (such as health literacy and system navigation). Few interventions exist to address disparities related to communication and system navigation in the inpatient setting; given the established links between these and disparate clinical outcomes, such interventions are needed. To address this gap, the study team collaborated with parents/caregivers, staff, and providers to develop and pilot-test a novel program to improve navigation ability, communication, and hospital-to-home transition for a broad population of children and their families, The Family Bridge Program (FBP).
The FBP combines principles of effective patient navigation and communication coaching interventions into a brief and targeted inpatient program. It is designed for a broad population of low-income children, is not disease-specific, is not limited to English proficient families, and is less time-intensive than traditional navigation, to enable provision of support to more families. The FBP, delivered in-person by a trained lay navigator, includes: (1) hospital orientation; (2) unmet social needs screening (e.g., food insecurity); (3) parent communication and cultural preference assessment, relayed to the medical team; (4) communication coaching for parents; (5) emotional support; (6) assistance with care coordination and logistics; and (7) a phone call 2 days post-discharge. Program elements are flexibly delivered based on parent need and interest.
In pilot testing, the program was feasible to deliver, acceptable to parents and providers, and significantly improved parent-reported system navigation ability. The current R01 proposes a two-site randomized controlled trial (RCT) of the effectiveness of FBP among 728 families of low-income children. Enrolled families will be randomized 1:1 (stratified by site and language) to FBP or usual care plus written resources. The specific aims of this clinical trial are to (1) Test the effect of the FBP on parent-reported system navigation ability, quality of hospital-to-home transition, diagnosis comprehension, observed communication quality, perceived stress and revisits; (2) Examine whether changes in parent-reported barriers and needs mediate program effects; and (3) Identify subgroups of parents among whom the FBP is more effective. The proposed RCT will use a rigorous design to test a feasible, innovative program to address a critical national problem. If effective, the Family Bridge Program would provide a scalable model for improving health care experiences and outcomes for families of low-income children at risk for disparities, including those who prefer a language other than English for their medical care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Bridge Program | Experimental | Behavioral: Family Bridge Program |
| Care as Usual- Resources Only | Active comparator | Behavioral: Care as usual - resources only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 ProgramThe Family Bridge Program consists of 7 components, delivered by a trained lay navigator, the Guide. The program includes: (1) orientation to the hospital, unit, room, and hospital resources (e.g., toiletries, loaner phone chargers); (2)unmet social needs assessment, followed by connection to appropriate resources (e.g., food vouchers, community-based transportation); (3)communication and cultural preference assessment (eg, preferred language, comfort asking questions, and health-related cultural beliefs), which is communicated to the medical team and documented in the electronic health record;(4)communication coaching for parents/caregivers to help them clarify and practice asking questions of the medical team; (5)emotional support via daily check-ins during the hospital stay; (6)assistance with logistics ; and (7)one follow-up phone call, 2 days post-discharge, to address remaining questions and connect families to ongoing services if needed. | Behavioural | Family Bridge Program |
| Care as usual - resources onlyFamilies randomized to the control arm will receive FBP written resources, which the Guide (and interpreter, as needed) will review with them over ~5-15 minutes one time. This includes information on hospital services (e.g., cafeteria coupons), community resources (e.g., food and housing support), the structure and roles of the medical team, and the daily hospital schedule. Parents will be informed that their child's nurse is available to help them. | Behavioural | Care as Usual- Resources Only |
Primary outcome
System Navigation Ability
Time frame: Enrollment and 2-6 weeks after discharge
Change score -100 to 100, based on 10-item measure of parent self-reported ability to navigate the healthcare system (e.g., ability to schedule appointments or ask questions). Each response of Yes (100), Sometimes (50), or No (0) is averaged to create overall score. Change score as difference from enrollment to follow-up
Pediatric Transition Experience Measure (P-TEM)
Time frame: 2-6 weeks after discharge
Percent of items with "top-box" score, based on the Pediatric Transition Experience Measure (P-TEM), an 8-item measure to assess hospital-to-home transition. Responses are on Likert scale from 0 to 5, with top-box scoring for overall measure.
9 secondary outcomes
Diagnosis Comprehension
Time frame: 2-6 weeks after discharge
Perceived Stress Scale
Time frame: 2-6 weeks after discharge
Observed Communication: utterances in which team offers information
Time frame: Day 1-5 of hospital admission
Observed Communication: utterances in which team offers supportive talk
Time frame: Day 1-5 of hospital admission
Observed Communication: utterances in which parent asks questions
Time frame: Day 1-5 of hospital admission
Observed Communication: utterances in which parent responds assertively
Time frame: Day 1-5 of hospital admission
Observed Communication: parent talk-time
Time frame: Day 1-5 of hospital admission
Observed Communication: global partnership rating
Time frame: Day 1-5 of hospital admission
30-day readmissions
Time frame: 30 days after discharge from index hospital stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 and Care as usual - resources only in people with General Pediatric Medical Conditions and Healthcare System Navigation, run by Seattle Children's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
System Navigation Ability (time frame: Enrollment and 2-6 weeks after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.