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临床试验/NCT06919445
NCT06919445已完成不适用

Novel Mobile Resource for Food Insecurity Randomized Controlled Trial

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 608 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
608
试验地点
2
主要终点
Resource Connection (Effectiveness)

研究概览

简要总结

The goal of this clinical trial is to learn if a novel text-message-based intervention is a more effective method for providing food resource information to families of recently hospitalized children who are experiencing food insecurity compared to the current standard practice of a paper handout delivered at the time of hospital discharge. The hypotheses the investigators seek to prove are:

  1. That the Text Connect intervention will have greater reach and engagement and be more effective in facilitating connection to food resources than receiving a paper handout alone.
  2. That the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.

详细描述

The mHealth intervention, Text Connect, leverages universal FI screening embedded in the routine clinical care of hospitalized children and offers an innovative approach to providing food resource information that addresses previously identified challenges. The anonymous nature of the text message may empower families with concerns related to sharing their need to pursue resources. Leveraging an already existing online social resource database that is frequently updated and searchable by ZIP Code in many different languages ensures that community program information is accurate, relevant, and tailored to the user's needs. Automated delivery to a personal device addresses the barrier of not receiving referral information and enables patients and families to utilize the information when most convenient for them. Importantly, it is also a promising approach to disseminating this information to all individuals with FI. While development of an app or link in an online portal is a possible electronic information dissemination approach, there are known challenges in accessing such tools that would limit use by many in the population that most frequently experiences FI.

By leveraging an electronic health record vendor's (Epic) native screening questions to identify eligible families and an external social resource database to provide tailored resources, this approach is scalable to other care settings, other domains of needs, and other institutions. Most importantly, successful implementation of this intervention holds the potential to improve family food security and child health outcomes.

The investigator's pilot study testing the feasibility, usability, and acceptability of this proposed approach to resource provision demonstrated that the intervention reaches the majority of the intended population, over half of recipients engage with the content, has excellent usability, and is acceptable to families. Thus, the overarching goal of this proposal is to rigorously test this approach to resource information delivery through a randomized controlled trial to inform health-system approaches to providing social resource information in response to screening. The specific aims are:

Aim 1: In a randomized controlled trial, the investigators will test the reach, engagement, and effectiveness of resource connection of the mHealth intervention, Text Connect, as compared to usual care, a paper resource handout, among families with FI. The investigators hypothesize that the mHealth intervention Text Connect will have greater reach and engagement and be more effective in facilitating connection to food resources than receiving a paper handout alone.

Aim 2: Assess the impact of the Text Connect intervention on household food and nutrition security status, perceived stigma, and trust in the healthcare team compared to usual care. The investigators hypothesize that the Text Connect intervention will improve household food security to a greater degree than a paper handout alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Must be a caregiver of a child admitted to the hospital
  • •Must have a positive screening for Food Insecurity documented in the Electronic Health Record as conducted as part of the child's routine clinical care

排除标准

  • •Primary language other than English or Spanish
  • •Repeat admission during the study period

研究组 & 干预措施

Usual Food Resources Control

No Intervention

Caregivers included in the usual care group receive a paper food resource handout as part of their discharge paperwork. This paper is given to the family and reviewed by the nurse completing their discharge. Families may also meet with a resource navigator during admission if they indicate a desire to talk with someone about food resources during their hospitalization. Finally, all caregivers with FI identified during screening are eligible to receive a food box or frozen meal at the time of discharge from the hospital.

Usual Food Resources PLUS Text Connect Intervention

Experimental

Caregivers included in the intervention arm receive a 'Text Connect' message with food resource information one day and four days after discharge in addition to the usual care information received by the control group

干预措施: 'Text Connect' text messages (Other)

结局指标

主要结局

Resource Connection (Effectiveness)

时间窗: Days 5, 12, and 30

Effectiveness is measured as the proportion of caregivers who report (Yes/No) getting a new food resource since getting home from their child's hospitalization.

Caregiver-reported Reach

时间窗: 5, 12, & 30

Reach will be measured among intervention and control groups as the proportion of caregivers who report receiving the text message (intervention) or paper handout (control)

System-collected Reach

时间窗: Day 1 and 4

Will be measured among among the intervention cohort as the proportion of caregivers who have successful delivery of at least one Text Connect intervention message as recorded by Twilio report of text message delivery

Caregiver-reported Engagement with information

时间窗: Days 5, 12, and 30

Measured among control and intervention groups as the proportion of caregivers who report reading (Yes/No) or using the content of the discharge resource handout (control) or text message (intervention) to search for a new resource

System-collected Engagement with information

时间窗: Days 1 and 4

Measured among the intervention group as the proportion of caregivers who click on the embedded FindHelp search link

次要结局

  • Food Security(Day 30)
  • Nutrition Security(Day 30)
  • Resilience(Day 30)
  • Stigma(Day 30)
  • Trust in Health Care System(Day 30)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristin Fritz

Assistant Professor of Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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