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Social Navigator to Address Social Determinants of Health in Pediatrics

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Social Navigator
Sponsored by
Children's Hospital of Eastern Ontario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Phase 1 Age between 0-17 years Patient in the Type 1 diabetes (T1D) or Type 2 diabetes (T2D) clinics at CHEO Dyad participation (parent/caregiver-child) Phase 2 Meet the Phase 1 eligibility criteria At least 1 positive response on the SDH screening tool Exclusion Criteria: Active social work client at the time of the screening, defined as individuals who self- identify as having active follow up with a diabetes SW to address social need(s) Unable or unwilling to provide i) implied consent for the completion of the SDH screening tool and/or ii) written informed consent for participation in the randomized trial

Sites / Locations

  • Children's Hospital of Eastern Ontario - Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To compare the time to access NSRCH (social navigator) vs. standard care (social worker).
To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.
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).
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).
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.

Full Information

First Posted
April 19, 2023
Last Updated
June 12, 2023
Sponsor
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT05900505
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Eastern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants in the intervention group will be referred to a social navigator to address their identified social needs.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in the control group will be referred to a social worker, as per standard care.
Intervention Type
Other
Intervention Name(s)
Social Navigator
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare participant satisfaction with NSRCH (social navigator) vs. standard care (social worker), as measured by the Client Satisfaction Questionnaire (CSQ).
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To compare the time to access NSRCH (social navigator) vs. standard care (social worker).
Time Frame
6 months
Title
To compare the rate of attendance to NSRCH (social navigator) vs. standard care (social worker) visits.
Time Frame
6 months
Title
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).
Time Frame
6 months
Title
To compare whether resources provided to the participants corresponded to their identified social needs at NSRCH (social navigator) vs. standard care (social worker).
Description
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).
Time Frame
6 months
Title
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.
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
To compare NSRCH (social navigator) vs. standard care (social worker) with respect to changes in glycemic control.
Description
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.
Time Frame
6 months
Title
Change in Social Determinants of Health (SDH) Screening Status
Description
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).
Time Frame
6 months
Title
To compare the resource cost of the social navigator compared to the social worker.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Phase 1 Age between 0-17 years Patient in the Type 1 diabetes (T1D) or Type 2 diabetes (T2D) clinics at CHEO Dyad participation (parent/caregiver-child) Phase 2 Meet the Phase 1 eligibility criteria At least 1 positive response on the SDH screening tool Exclusion Criteria: Active social work client at the time of the screening, defined as individuals who self- identify as having active follow up with a diabetes SW to address social need(s) Unable or unwilling to provide i) implied consent for the completion of the SDH screening tool and/or ii) written informed consent for participation in the randomized trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias Abou-Assaly, BA
Phone
613-737-7600
Ext
6940
Email
eabouassaly@cheo.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Saunya Dover, MSc
Phone
613-737-7600
Ext
4874
Email
sdover@cheo.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Zuijdwijk, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario - Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias Abou-Assaly, BA
Phone
613-737-7600
Ext
6940
Email
eabouassaly@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Saunya Dover, MSc
Phone
613-737-7600
Ext
4874
Email
sdover@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Caroline Zuijdwijk, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Social Navigator to Address Social Determinants of Health in Pediatrics

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