Clinical trial NCT05900505: Social Navigator to Address Social Determinants of Health in Pediatrics
Official title: Addressing Child and Family Social Determinants of Health Needs With Social Navigation: Navigating Social Resources for Children's Health "NSRCH" Clinic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 104
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Phase 1

* 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

Phase 2

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).
timeFrame: 6 months
Secondary outcomes:
measure: To compare the time to access NSRCH (social navigator) vs. standard care (social worker).
timeFrame: 6 months
measure: To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
measure: To compare whether resources provided to the participants corresponded to their identified social needs at NSRCH (social navigator) vs. standard care (social worker).
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
measure: To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control.
timeFrame: 6 months
measure: Change in Social Determinants of Health (SDH) Screening Status
timeFrame: 6 months
measure: To compare the resource cost of the social navigator compared to the social worker.
timeFrame: 6 months
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario - Research Institute
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Caroline Zuijdwijk, MD
role: PRINCIPAL_INVESTIGATOR
References: