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

NCT04211025 | Completed

• 1 other identifier: Project ID 1532
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

Brief Summary

Research question and objectives This pilot study will help us answer the following research question: Is it feasible to conduct a large cluster randomized controlled trial (RCT) of an intervention that consists of routine screening for poverty and related social determinants and intervening in Canadian primary care clinics, and what is the sample size required? Our objectives include:

1. 1.to collect data on the feasibility of recruiting clinics for a large cluster randomized controlled trial (RCT)
2. 2.to collect data on the acceptability and feasibility of integrating a standardized socio-demographic data collection tool, including screening for poverty, within diverse primary care clinic workflows
3. 3.collect data on the acceptability and feasibility of "modest" and "intensive" interventions on poverty (discussed below)
4. 4.collect data on the recruitment rate of patients, to assist with calculating the sample size for a larger cluster RCT
5. 5.collect data on the intervention effect size of the "modest" and "intensive" interventions on income and health outcomes to assist with calculating the sample size for a larger cluster RCT .

Conditions

Primary Care

Keywords

Sociodemographic Screening; Income; Primary Care; Social Needs

Outcome Measures

Primary Outcomes (2)

• Access to Additional Benefits

  The primary outcome measure will be whether or not participants accessed additional benefits and/or increased income as a result of participating in the study. This will be determined through the phone surveys with participants, conducted by the study team

  2 months follow-up

• Access to Additional Benefits

  The primary outcome measure will be whether or not participants accessed additional benefits and/or increased income as a result of participating in the study. This will be determined through the phone surveys with participants, conducted by the study team

  4 months follow-up

Secondary Outcomes (7)

• Implementation data (sociodemographic and social needs survey)

  Through study completion, up to 1 year

• Implementation data (income screening question)

  Through study completion, up to 1 year

• Implementation data (income assistance indication)

  Through study completion, up to 1 year

• Implementation data (recruitment and staff time)

  Through study completion, up to 1 year

• Implementation data (staff time)

  Through study completion, up to 1 year

Study Arms (2)

Modest

EXPERIMENTAL

This approach is feasible to integrate into workflows of a wide-range of clinics, and should have a minimal impact on human resources. Materials and strategies to support staff in this work will be provided. .

Other: Modest

Intensive

EXPERIMENTAL

This approach is more robust, and requires a greater commitment of human resources.

Other: Intensive

Interventions

Modest OTHER

The modest intervention consists of a 30-minute appointment (by phone or in-person) with the designated staff using the Benefits Screening Tool , and a plan is developed. At 4 weeks, the designated staff follows-up with a phone call or email.

Modest

Intensive OTHER

The intensive intervention consists of a 30-minute appointment with the designated staff using the Benefits Screening Tool , and a plan is developed. At 4 weeks, a follow-up appointment is booked for 30 minutes, and progress on the plan is assessed. At 12 weeks after the initial meeting, the designated staff follows-up with a phone call or email.

Intensive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient who completed the sociodemographic and social needs survey in their primary care organization.
• Answers "Yes" to the question "Do you have difficulty making ends meet at the end of the month?" and answers "Yes" to the question "Our clinic is part of a study of how to help patients who may be eligible for financial benefits. Would you like to take part?"
• Able to provide consent
• Age is greater than or equal to 18
• Able to converse in English
• Able to be reached via telephone, email, or through coordination with their clinic site

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (6)

Queen's Family Health Team

Kingston, Ontario, K7L 5E9, Canada

Location

Platinum Medical Clinic

Scarborough Village, Ontario, M1J 2H3, Canada

Location

New Family Medicine Network, North York Family Health Team

Toronto, Ontario, M2K 2W2, Canada

Location

Southeast Toronto Family Health Team

Toronto, Ontario, M4C 5T2, Canada

Location

East End Community Health Centre

Toronto, Ontario, M4L 1G4, Canada

Location

Access Alliance

Toronto, Ontario, M6N 4B4, Canada

Location

Study Officials

• Andrew D Pinto, MD MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention Our intervention consists of two parts: 1. Routine screening for sociodemographics and social needs such as poverty 2. Intervening when poverty is identified through linkage to a trained staff member who uses a Benefits Screening Tool to identify benefits that the patient is entitled to, and then provides support

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: December 26, 2019
• Study Start: April 15, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 29, 2021
• Last Updated: January 31, 2025

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)