Clinical trial NCT02459184: addressInG iNcome securITy in Primary carE
Official title: IGNITE (addressInG iNcome securITy in Primary carE) Study: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Poverty
Income
Social Determinants of Health
Keywords: preventive medicine
social determinants of health
primary health care
poverty
income
health promotion
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in monthly income from baseline to 6 months after intervention
timeFrame: 6 months
Secondary outcomes:
measure: quality of life: Change in scores on the WHO QoL-BREF and EQ-5D-5L
timeFrame: 12 months
measure: quality of life (overall health, mental health, physical health): change in units on a measured scale of EQ VAS
timeFrame: 12 months
measure: community integration: Change in scores on the Community Integration Scale
timeFrame: 12 months
measure: financial literacy: Change in scores on the Canadian Centre for Financial Literacy Personal Financial Literacy Quiz
timeFrame: 12 months
measure: co-morbidities and medication access
timeFrame: 12 months
measure: other social determinants
timeFrame: 12 months
measure: food security
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Andrew D Pinto, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: