Social Navigator to Address Social Determinants of Health in Pediatrics

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Social Navigator

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saunya Dover, MSc; Phone Number: 4874 613-737-7600; Email: sdover@cheo.on.ca
• Study Contact Backup: Name: Elias Abou-Assaly, BA; Phone Number: 6940 613-737-7600; Email: eabouassaly@cheo.on.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L1
      • Recruiting
      • Children's Hospital of Eastern Ontario - Research Institute
      • Contact: Saunya Dover, MSc; Phone Number: 4874 613-737-7600; Email: sdover@cheo.on.ca
      • Contact: Elias Abou-Assaly, BA; Phone Number: 6940 613-737-7600; Email: eabouassaly@cheo.on.ca
      • Principal Investigator: Caroline Zuijdwijk, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants in the intervention group will be referred to a social navigator to address their identified social needs.	Other: Social Navigator; The social navigator will assess patient/family needs and help them to access community resources (specific to their community) to address these, while promoting their engagement and self-efficacy.
No Intervention: Control Group; Participants in the control group will be referred to a social worker, as per standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the time to access NSRCH (social navigator) vs. standard care (social worker).		6 months
To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.		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).	The social workers and social navigator will be required to indicate which resources were referred to each participant. They will also be required to indicate if the resource corresponds to one or more of the participant's identified social need(s). The mean percentage of resources that correspond to identified social needs will be compared between NSRCH (social navigator) and standard care (social workers).	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.	Quality of Life: change in quality of life from baseline to end of study (pre/post intervention) will be compared between the NSRCH and standard care groups. Quality of life will be assessed using the World Health Organization Quality of Life - Brief Version (WHOQOL-BREF). The WHOQOL-BREF is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. Higher scores denote a higher quality of life. This measure provides 4 domain scores, one for each domain in which quality of life is assessed: physical (raw score 7-35), psychological (raw score 6-30), social relationships (raw score 3-15), and environment (raw score 8-40). Raw scores can also be transformed to reflect scores of 4-20 or 0-100.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Determinants of Health (SDH) Screening Status	To compare the change in positive screen status on the SDH screening tool from baseline to 6 months, in NSRCH (social navigator) vs. standard care (social worker).	6 months
To compare the resource cost of the social navigator compared to the social worker.		6 months
To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control.	To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control: Glycated hemoglobin (HbA1c, (%)), percent time in range (TIR - percentage of time in previous 14 days spent within target glucose range of 70-180 mg/dL or 3.9-10 mmol/L), and glucose management indicator (GMI, %). Taken together, these indicators reflect overall glycemic control.	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Eastern Ontario
• Investigators: Principal Investigator: Caroline Zuijdwijk, MD, Children's Hospital of Eastern Ontario

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 22/65X

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No