Social Navigator to Address Social Determinants of Health in Pediatrics

NCT ID: NCT05900505

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2024-12-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Social Navigator

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Caroline Zuijdwijk

Pediatric Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caroline Zuijdwijk, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario

Locations

Children's Hospital of Eastern Ontario - Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Elias Abou-Assaly, BA

Role: CONTACT

eabouassaly@cheo.on.ca

613-737-7600 ext. 6940

Saunya Dover, MSc

Role: CONTACT

sdover@cheo.on.ca

613-737-7600 ext. 4874

Facility Contacts

Elias Abou-Assaly, BA

Role: primary

eabouassaly@cheo.on.ca

613-737-7600 ext. 6940

Saunya Dover, MSc

Role: backup

sdover@cheo.on.ca

613-737-7600 ext. 4874

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

22/65X

Identifier Type: -

Identifier Source: org_study_id