Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK)

NCT04461080 | Not Yet Recruiting

• 1 other identifier: UpstreamLab2020-1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Poverty

Keywords

poverty; income; social determinants of health

Outcome Measures

Primary Outcomes (1)

• change in estimated annual income

  The primary outcome will be change in estimated annual income, assessed at baseline and at 6 months.

  6 months

Study Arms (2)

Integrated care promoter

EXPERIMENTAL

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.

Behavioral: Community Health Worker

Information on community resources

ACTIVE COMPARATOR

Patients randomized to the control group will receive a list of tailored written information.

Behavioral: Community Health Worker

Interventions

Community Health Worker BEHAVIORAL

Trained Community Health Worker

Information on community resources; Integrated care promoter

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will ask participants both their sex assigned at birth and their current gender identity, and offer a number of options.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + years old AND live in a household with an income below the Low-Income Cut-OFF AND agree to receive assistance with social needs

You may not qualify if:

• Has worked with a similar CHW or intervention in the past 1 year.

Sponsors & Collaborators

• Unity Health Toronto: lead
• Memorial University of Newfoundland: collaborator
• Dalhousie University: collaborator
• University of Manitoba: collaborator
• University of Saskatchewan: collaborator

Related Links

• Website for the SPARK Study

MeSH Terms

Interventions

Community Health Workers

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Andrew D Pinto, MD MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Cassano, BA

CONTACT

416-864-6060; antonio.cassano@unityhealth.to

Sabrina Aimola, MPH

CONTACT

416-864-6060; rose.wang@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel, two-arm 1:1 individual participant allocation randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 8, 2020
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Requests to access the data can be made beginning 3 months and up until 2 years after article publication.
• 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.