addressInG iNcome securITy in Primary carE (IGNITE)

IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial

Social processes that impact the health of individuals have been labeled the social determinants of health (SDOH). These are "the conditions in which people are born, grow, live, work and age. These circumstances are shaped by the distribution of money, power and resources at global, national and local levels". Perhaps the most important SDOH is income security, a person's actual, perceived and expected income. Our objective is to carry out a pragmatic randomized controlled trial that evaluates the impact of an income-focused health promoter.

Study Overview

• Status: Active, not recruiting
• Conditions: Social Determinants of Health; Poverty; Income
• Intervention / Treatment: Other: Income Security Health Promotion

Detailed Description

This study aims to answer the question: What is the impact of an income security health promotion service based in a primary care setting on the income security of people living in poverty? We hypothesize that an income security health promotion service for adults living in poverty will increase monthly income relative to usual care. We will carry out a pragmatic randomized controlled trial that evaluates the impact of such a new service focused on income security health promotion. The St. Michael's Hospital Academic Family Health Team has received ongoing funding from the Ministry of Health and Long-Term Care (MOHLTC) to support this service. The primary outcome is income security, and secondary outcomes include quality of life, financial literacy and community integration.

Population - Adults living in poverty Intervention - Income security health promotion Control - Usual care Outcome - Primary: Improvement in income per month in the intervention group at 6 months (post-intervention) compared to income in control group at 6 months (pre-intervention). Secondary: quality of life, self-rated health, community engagement.

• Study Type: Interventional
• Enrollment (Actual): 284
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18
• Lives within the Metropolitan catchment areas
• Lives in a postal code that is in the lowest income quintile, or has had a billing code specific to social assistance forms billed ever billed, or has been identified as low income based on reported family income and number of people supported by income on the "Health Equity Data"
• Patient of the Family Health team including those that are: rostered, non-rostered, refugee claimants (IFH) or uninsured seen in the FHT.
• Verified by the patient's family physician as living in poverty, a good candidate for the intervention, and the patient's family physician agrees to have a letter submitted with his/her name attached.

Exclusion Criteria:

• Patients who have previously worked with the Income Security Health Promoter, or are part of households of people who have previously worked with the Income Security Health Promoter.
• Patients who have no available contact information for mailing.
• Patients of any member of the investigative team.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intervention; Participants will meet with the Income Security Health Promoter immediately.	Other: Income Security Health Promotion; The ISHP will work to improve the income security of participants within this study. To that end, her activities include: Providing one-to-one case management support and ongoing follow-up to diverse low-income patients and families regarding their income security.; Developing and implementing targeted information self-help sessions, such as; banking basics, income tax submissions, and social service forms, for the target population; Developing and maintaining up-to-date detailed knowledge of financial issues and financial services affecting low-income people, and applying this knowledge in his/her work.; Assisting individual low-income patients with income security-focused interventions, including access to tax benefits, applications for income security programs such as social assistance and seniors and child benefits, and navigation of disability support programs.
Active Comparator: Late intervention; Participants will meet with the Income Security Health Promoter at 6 months.	Other: Income Security Health Promotion; The ISHP will work to improve the income security of participants within this study. To that end, her activities include: Providing one-to-one case management support and ongoing follow-up to diverse low-income patients and families regarding their income security.; Developing and implementing targeted information self-help sessions, such as; banking basics, income tax submissions, and social service forms, for the target population; Developing and maintaining up-to-date detailed knowledge of financial issues and financial services affecting low-income people, and applying this knowledge in his/her work.; Assisting individual low-income patients with income security-focused interventions, including access to tax benefits, applications for income security programs such as social assistance and seniors and child benefits, and navigation of disability support programs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in monthly income from baseline to 6 months after intervention	Change in monthly income from baseline to 6 months after intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L	Change in scores on the WHO QoL-BREF and EQ-5D-5L	12 months
quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS	changes in units on a measured scale	12 months
community integration: Change in scores on the Community Integration Scale	Change in scores on the Community Integration Scale	12 months
financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz	Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz	12 months
co-morbidities and medication access	changes to scores relating to comorbidities and medication access	12 months
other social determinants	changes scores relating to housing and employment	12 months
food security	changes in scores on Health Canada food security module	12 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Andrew D Pinto, MD MSc, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): July 9, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: primary health care; health promotion; social determinants of health; poverty; preventive medicine; income
• Other Study ID Numbers: SMH2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: In consultation with our institutional Research Ethics Board, we will consider release of IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No