跳至主要内容
临床试验/NCT05900505
NCT05900505招募中不适用

Addressing Child and Family Social Determinants of Health Needs With Social Navigation: Navigating Social Resources for Children's Health "NSRCH" Clinic

Children's Hospital of Eastern Ontario2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2023年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
104
试验地点
2
主要终点
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).

研究概览

简要总结

It is crucial to understand the social and economic context in which children and youth live; their social determinants of health (SDH). Although this is well recognized, many health care providers do not address SDH because of the lack of easily accessible resources once social needs are identified.

Social workers (SW) have the ability to support families once a social need has been identified. However, not every clinic has a SW, and even those that do often struggle to meet the needs of all the families requiring support.

The use of social navigators (SN) is an innovative solution for an unmet need. SN models have been successful in primary care settings, but, to date, have not been adapted to address the SDH needs of children and their families receiving care in pediatric specialty care settings. We will implement the first of its kind pediatric SN clinic at the Children's Hospital of Eastern Ontario (CHEO): "Navigating Social Resources for Children's Health" (NSRCH). Our study will evaluate NSRCH - an innovative, transferable, and low-cost pediatric-specific SN model. Our goal is to support families with SDH needs to access timely, appropriate supports and resources via NSRCH.

详细描述

In Phase 1 of our study, potential patient-participants will be identified from the type 1 diabetes and type 2 diabetes clinics at CHEO in the following way: the study coordinator will manually screen upcoming patients in the diabetes clinic schedules in Epic. Then, a cover letter and study information sheet will be sent to potential patient-participants (or they would be approached by a study coordinator in-person during the clinic visit). They will follow up with the family to explain the study, answer any questions, confirm interest. Interested families will be asked to complete the Phase 1 Screening Tool.

The study coordinator will be automatically notified of all positive screens (at least 1 identified social need), and then contact the respective families to invite them to participate in Phase 2 of the study and obtain informed consent.

At baseline, the coordinator will collect baseline data and have the families complete the Quality of Life - Brief Version (WHOQOL-BREF) and Baseline Questionnaire. After the visit, participants will be randomized to the intervention or control groups using the randomization module in REDCap. A referral will then be forwarded to either the SN or SW. All clinic visits between baseline and follow up will be scheduled directly by the SN or SW. The SN and the SW will be asked to complete a checklist for each participant consultation, and the results will be summarized by the coordinator.

Participants will be contacted by a coordinator for a follow up visit at 6 months. At which time, they will collect follow-up data and have the families complete the Phase 1 Screening Tool, WHOQOL-BREF, and CSQ.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent or guardian of a child, aged between 0-17 years
  • Parent or guardian of a patient in the T1D or T2D clinics at CHEO
  • Parent or guardian of a child, aged between 0-17 years
  • Parent or guardian of a patient in the T1D or T2D clinics at CHEO
  • At least 1 positive response on the SDH Phase 1 Screening Tool
  • Optional: child consented to allow access to medical information via electronic medical chart

排除标准

  • Active social work client at the time of administration of the Phase 1 Screening Tool, defined as families who have had active follow up with a diabetes SW within the last 3 months, with plans for ongoing follow up.
  • Unable or unwilling to provide i) implied consent for the completion of the SDH Phase 1 Screening Tool and/or ii) written informed consent for participation in the Phase 2 randomized trial

研究组 & 干预措施

Intervention Group

Experimental

Participants in the intervention group will be referred to a social navigator to address their identified social needs.

干预措施: Social Navigator (Other)

Control Group

No Intervention

Participants in the control group will be referred to a social worker, as per standard care.

结局指标

主要结局

To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).

时间窗: 6 months

Client Satisfaction Questionnaire: Participant satisfaction will be determined using a validated Client Satisfaction Questionnaire (CSQ). The CSQ is scored on a scale of 8 to 32, with higher scores indicating higher satisfaction.

次要结局

  • To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.(6 months)
  • To compare change in Quality of Life (QOL) of participants (pre/post intervention) referred to NSRCH (social navigator) vs standard care (social worker), as measured by the WHOQOL-BREF.(6 months)
  • To compare the time to access NSRCH (social navigator) vs. standard care (social worker).(6 months)
  • To compare the number of community resources accessed by participants relative to the number of community resources to which they were referred by NSRCH (social navigator) vs. standard care (social worker).(6 months)
  • To compare whether resources provided to the participants corresponded to their identified social needs at NSRCH (social navigator) vs. standard care (social worker).(6 months)

研究者

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

Caroline Zuijdwijk

Pediatric Endocrinologist

Children's Hospital of Eastern Ontario

研究点 (2)

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