Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) (SPARK)
June 17, 2024 updated by: Unity Health Toronto
Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK): a Randomized Controlled Study
The SPARK RCT will test the impact of engagement with a Community Health Worker who is embedded in interprofessional primary care teams on change in estimated annual income at 6 months for people living in poverty.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Population: Patients seen by interprofessional primary care teams who are living on estimated annual incomes that are below the Canadian Low-Income Cut-Off (LICO)
Intervention: A Community Health Worker who implements an intervention that addresses a number of social needs, including improving income security, access to prescription medications, access to housing, reducing social isolation, paying for utilities and access to transportation
Control: Information on community resources on social needs
Outcome: Change in estimated annual income between baseline and at 6 months
Study Type
Interventional
Enrollment (Estimated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Antonio Cassano, BA
- Phone Number: 40218 416-864-6060
- Email: antonio.cassano@unityhealth.to
Study Contact Backup
- Name: Sabrina Aimola, MPH
- Phone Number: 7819 416-864-6060
- Email: rose.wang@unityhealth.to
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18+ years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs
Exclusion Criteria:
- Has worked with a similar CHW or intervention in the past 1 year.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Integrated care promoter
Patients who are randomized to the intervention group will be connected with a trained Community Health Worker (CHW).
The CHW is a peer with lived-experience of system navigation that could have a background in social work, health promotion or community work.
All CHWs will receive 2 weeks of training to assist participants with social needs.
|
Trained Community Health Worker
|
|
Active Comparator: Information on community resources
Patients randomized to the control group will receive a list of tailored written information.
|
Trained Community Health Worker
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in estimated annual income
Time Frame: 6 months
|
The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew D Pinto, MD MSc, University of Toronto
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 2, 2020
First Submitted That Met QC Criteria
July 2, 2020
First Posted (Actual)
July 8, 2020
Study Record Updates
Last Update Posted (Actual)
June 18, 2024
Last Update Submitted That Met QC Criteria
June 17, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UpstreamLab2020-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data from this study will be made available to qualified researchers with academic interest in primary care health equity research.
Data will only be made available to interested parties after all applicable agreements have been executed.
IPD Sharing Time Frame
Requests to access the data can be made beginning 3 months and up until 2 years after article publication.
IPD Sharing Access Criteria
Access to study IPD will be granted to qualified researchers upon approval of their Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
To submit a request or for any additional questions, please contact Upstreamlab@unityhealth.to.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.