Social Navigator to Address Social Determinants of Health in Pediatrics

NCT05900505 | Recruiting

• 1 other identifier: 22/65X
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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).

  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

Other Outcomes (3)

• To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control.

  6 months

• Change in Social Determinants of Health (SDH) Screening Status

  6 months

• To compare the resource cost of the social navigator compared to the social worker.

  6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Social Navigator

Control Group

NO INTERVENTION

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

Interventions

Social Navigator OTHER

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.

Intervention Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario - Research Institute

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Caroline Zuijdwijk, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias Abou-Assaly, BA

CONTACT

613-737-7600; eabouassaly@cheo.on.ca

Saunya Dover, MSc

CONTACT

613-737-7600; sdover@cheo.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: June 12, 2023
• Study Start: June 26, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)