Addressing Unmet Social Needs Among Hospitalized Children

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05968716

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Social Needs Screening Caregiver-care Team Relationships Social Needs Status Child Health Status Caregiver Health Status Utilization, Health Care	Other: Social needs screening protocol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Addressing Unmet Social Needs Among Hospitalized Children

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Other: 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.

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

Feasibility of protocol implementation [6 months after first meeting of protocol committee]
Feasibility of developing and implementing a social needs screening and intervention - measured dichotomously (yes/no) whether the protocol was developed and implemented within 6 months
Acceptability of social needs screening [Up to 6 months post baseline data collection]
Caregiver acceptability will be assessed using baseline surveys administered during inpatient recruitment in the pre-/ and post-protocol implementation periods. Care team member acceptability will be assessed using surveys administered after protocol implementation - Likert scale derived from De Marchis et al.'s 2019 paper: Do you think it is appropriate to be asked questions about your social and economic needs during your child's hospitalization? a) Very appropriate b) Somewhat appropriate c) Neither appropriate nor inappropriate d) Somewhat inappropriate e) Very inappropriate

Secondary Outcome Measures

Recruitment rate [Up to 12 months after first meeting of protocol committee]
Proportion of caregivers recruited out of 50
Retention retention rate [Up to 15 months after first meeting of protocol committee]
Proportion of caregivers recruited that answer a post-hospitalization survey
Social needs screening rate [Up to 12 months after first meeting of protocol committee]
Proportion of families screened for social needs in the hospital
Caregiver-care team relationships [Up to 15 months after first meeting of protocol committee]
Assessments of the experience of caregivers with healthcare staff - Likert scale derived from De Marchis et al. 2019's paper: : How much do you trust your health care provider(s) at this hospital? 1 (not at all) through 10 (completely)
Family social needs [Up to 15 months after first meeting of protocol committee]
Depending on what social needs the inpatient unit decides to screen for (e.g., food insecurity, transportation needs), the investigators will measure the rates of those needs at the time of recruitment and then again 3 months post-discharge - dichotomous (i.e., presence or absence of food insecurity; presence or absence of transportation needs)
Child health status [Up to 15 months after first meeting of protocol committee]
Caregiver-endorsed measures of child health - Likert scale as derived from Gottlieb et al.'s 2020 paper: In general, would you say your child's health is: Excellent, very good, good, fair, poor
Rehospitalization rate [Up to 15 months after first meeting of protocol committee]
Proportion of children being readmitted within 3 months after discharge as reported by the caregiver
Post-hospitalization emergency department visit rate [Up to 15 months after first meeting of protocol committee]
Proportion of children being having an emergency department visit within 3 months after discharge as reported by the caregiver
Missed follow-up visit rate [Up to 15 months after first meeting of protocol committee]
Proportion of children missing a follow-up visit within 3 months after discharge as reported by the caregiver

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benioff Children's Hospital - San Francisco	San Francisco	California	United States	94158

Sponsors and Collaborators

University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator: Matthew S Pantell, MD, MS, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05968716

Other Study ID Numbers:

1K08HS028473-01A1
1K08HS028473-01A1

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 1, 2023