Clinical trial NCT05968716: Addressing Unmet Social Needs Among Hospitalized Children
Official title: Addressing Unmet Social Needs Among Hospitalized Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Social Needs Screening
Caregiver-care Team Relationships
Social Needs Status
Child Health Status
Caregiver Health Status
Utilization, Health Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will utilize a before-and-after trial design, whereby the "control group" consists of caregivers studied before a social needs screening protocol is implemented on a pediatric hospital ward, and the "intervention group" consists of caregivers studied after a social needs screening protocol is implemented on a pediatric hospital ward.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol. The investigators will work with pediatric word healthcare team members to develop a social needs screening and intervention protocol. They will then compare preliminary health and social outcome measures between children hospitalized during the pre-intervention period (control group) vs. the post-intervention period (intervention group).

Detailed description: Millions of children in the US live in families with unmet social needs, and numbers increased during the COVID-19 pandemic. Children with unmet social needs are at increased risk of experiencing worse health and health care outcomes, and addressing unmet social needs can improve health and reduce health care utilization. Consequently, many professional organizations now endorse screening for and addressing social needs in clinical settings. However, despite social needs screening recommendations, there are no established best practices for clinical settings, and there has not been much focus on the pediatric inpatient setting. In order to understand whether identifying and addressing social needs in the pediatric inpatient setting positively impacts social and health outcomes, interventions must be developed and assessed that seek to accomplish this. Before launching large trials to assess such interventions, the feasibility and acceptability of implementing social needs interventions in the pediatric inpatient setting must determined. The objective of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol in this setting.

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.

Eligibility criteria: Inclusion Criteria:

* Caregiver's child is hospitalized in the Transitional Care Unit (TCU) of Benioff Children's Hospital - San Francisco
* 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:

* Non-English or non-Spanish speaking caregiver
* 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

Primary outcomes:
measure: Feasibility of protocol implementation
timeFrame: 6 months after first meeting of protocol committee
measure: Acceptability of social needs screening
timeFrame: Up to 6 months post baseline data collection
Secondary outcomes:
measure: Recruitment rate
timeFrame: Up to 12 months after first meeting of protocol committee
measure: Retention retention rate
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Social needs screening rate
timeFrame: Up to 12 months after first meeting of protocol committee
measure: Caregiver-care team relationships
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Family social needs
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Child health status
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Rehospitalization rate
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Post-hospitalization emergency department visit rate
timeFrame: Up to 15 months after first meeting of protocol committee
measure: Missed follow-up visit rate
timeFrame: Up to 15 months after first meeting of protocol committee
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Benioff Children's Hospital - San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Matthew S Pantell, MD, MS
role: PRINCIPAL_INVESTIGATOR
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