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临床试验/NCT05968716
NCT05968716进行中(未招募)不适用

Addressing Unmet Social Needs Among Hospitalized Children

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
2
主要终点
Feasibility of protocol implementation

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control (pre-implementation) arm

No Intervention

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.

Intervention (post-implementation) arm

Experimental

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.

干预措施: Social needs screening protocol (Other)

结局指标

主要结局

Feasibility of protocol implementation

时间窗: 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

时间窗: 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

次要结局

  • Social needs screening rate(Up to 12 months after first meeting of protocol committee)
  • Rehospitalization rate(Up to 15 months after first meeting of protocol committee)
  • Family social needs(Up to 15 months after first meeting of protocol committee)
  • Recruitment rate(Up to 12 months after first meeting of protocol committee)
  • Caregiver-care team relationships(Up to 15 months after first meeting of protocol committee)
  • Child health status(Up to 15 months after first meeting of protocol committee)
  • Post-hospitalization emergency department visit rate(Up to 15 months after first meeting of protocol committee)
  • Retention retention rate(Up to 15 months after first meeting of protocol committee)
  • Missed follow-up visit rate(Up to 15 months after first meeting of protocol committee)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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