Addressing Unmet Social Needs Among Hospitalized Children
NCT ID: NCT05968716
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2023-11-08
2025-05-31
Brief Summary
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Detailed Description
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The investigators will utilize a before-and-after trial design to assess feasibility, acceptability, process, and preliminary outcome measures of implementing a social needs screening and intervention protocol in a tertiary children's hospital. Caregivers of hospitalized pediatric patients will be eligible to participate in surveys about screening acceptability and social and health outcomes if they are over 18 and their child is hospitalized on the transitional care general pediatrics unit within the 4 months prior to implementation of the protocol (control/pre-implementation group) or 4 months after the wash-in period (intervention/post-implementation group). Nurses, social workers, case managers, nurse practitioners, and physicians will be eligible to participate in a survey about protocol acceptability and satisfaction if they worked on the unit after protocol implementation.
A study team member will approach caregivers and ask if they would be potentially interested in filling out a survey about their experiences with being screened for social needs during their hospitalization and being contacted in 90 days for a follow-up survey. If interested, a study team member will screen the caregiver for eligibility and then obtain caregiver informed consent before administering the baseline survey. The consent will include a HIPAA authorization form to enable access to EHR records for the purposes of extracting utilization data (e.g., missed follow-up appointments). A follow-up survey will be administered via phone 3 months later. For care team members, an email will be sent to unit staff requesting participation in a voluntary survey regarding the social needs protocol with a link to the consent and survey included.
The investigators' goal is to recruit 25 caregivers in both the pre- and post-period, for a total of 50 caregivers. For the care team member survey, the hope is to gain as many members' input as possible. Based on the employee engagement response at the study site, the investigators believe that emailing roughly 93 care team members will respond.
The investigators will develop a social needs screening and intervention protocol for the ward based on: 1) input from unit leaders and stakeholders; 2) interviews from caregivers and care team members conducted previously. The goal is to develop and implement the protocol with a multidisciplinary group of unit stakeholders in 6 months.
Children hospitalized within the 4 months prior to intervention implementation will serve as the control group. Children hospitalized after a two-month "wash-in" period after protocol implementation will represent the intervention group. Post-intervention data will be collected for 4 months after implementation. The pilot will consist of roughly 50 caregivers of children and 93 care team members of the inpatient ward. This will allow us to estimate effect sizes for a future multi-site randomized clinical trial. Although The investigators may detect some intervention effects, the goal of the pilot is to assess feasibility and acceptability.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Control (pre-implementation) arm
Caregivers recruited from the pediatric hospital ward before the social needs screening and intervention protocol is implemented will compose the "control" group or pre-implementation group.
No interventions assigned to this group
Intervention (post-implementation) arm
Caregivers recruited from the pediatric hospital ward after the social needs screening and intervention protocol is implemented will compose the "intervention" group or post-implementation group.
Social needs screening protocol
Pediatric hospital ward stakeholders will develop and implement a social needs screening protocol designed to screen families of hospitalized children for social risk factors and then provide resources to address their social needs. The intervention will consist of the protocol that is developed and implemented.
Interventions
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Social needs screening protocol
Pediatric hospital ward stakeholders will develop and implement a social needs screening protocol designed to screen families of hospitalized children for social risk factors and then provide resources to address their social needs. The intervention will consist of the protocol that is developed and implemented.
Eligibility Criteria
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Inclusion Criteria
* English or Spanish Speaking
* Parent/caregiver accompanying a patient hospitalized 0-17 years old
* Consenting adult over or equal to 18 years old
* Initially admitted to the TCU
* Caregiver's child is part of a service for which pediatric residents or advance practice providers provide care
Exclusion Criteria
* Caregiver under age 18
* Family participated in study previously
* Caregiver's child was initially admitted to a unit besides the TCU
* Caregiver's child is NOT part of a service for which pediatric residents or advance practice providers provide care
18 Years
ALL
Yes
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Matthew S Pantell, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Benioff Children's Hospital - San Francisco
San Francisco, California, United States
Countries
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References
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