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

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

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. to collect data on the feasibility of recruiting clinics for a large cluster randomized controlled trial (RCT)
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. collect data on the acceptability and feasibility of "modest" and "intensive" interventions on poverty (discussed below)
4. collect data on the recruitment rate of patients, to assist with calculating the sample size for a larger cluster RCT
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 .

Study Overview

• Status: Completed
• Conditions: Primary Care
• Intervention / Treatment: Other: Modest; Other: Intensive

Detailed Description

Rationale Research carried out by members of the study team has found that routine socio-demographic data collection in primary care has significant potential. Such data could be used to better tailor care to a patient's social context, improve diagnostic accuracy by incorporating social determinants as risk factors, identify inequities in the uptake of health services and in health outcomes, stimulate the development of new programs, and advance research. However, a standard set of questions has not yet been developed in Canada. Significant challenges remain to implementation of routine socio-demographic data collection, particularly around patient engagement, staff training, and support to make use of data collected, including adjustment for non-response bias. Existing work has also found that health providers and organizations lack evidence-based interventions to address social needs, particularly poverty. Work to date by the study team has found that a prototype financial benefit tool could be integrated into clinic workflow, particularly if the right staff person was administering it and following up with patients, and approximately 17% of patients had received a financial benefit after 1 month. No study to date has examined the longer-term impact of such a tool on income and health. It is not known whether a "modest" intervention, with the tool integrated into a clinic visit and brief follow-up, would be as effective as a more "intensive" intervention, with a dedicated visit to use the tool and multiple follow-up visits

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 5E9
      • Queen's Family Health Team
    • Scarborough, Ontario, Canada, M1J 2H3
      • Platinum Medical Clinic
    • Toronto, Ontario, Canada, M2K 2W2
      • New Family Medicine Network, North York Family Health Team
    • Toronto, Ontario, Canada, M4C 5T2
      • Southeast Toronto Family Health Team
    • Toronto, Ontario, Canada, M4L 1G4
      • East End Community Health Centre
    • Toronto, Ontario, Canada, M6N 4B4
      • Access Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients: The inclusion criteria are as follows:

1. A patient who completed the sociodemographic and social needs survey in their primary care organization.
2. 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?"
3. Able to provide consent
4. Age is greater than or equal to 18
5. Able to converse in English
6. Able to be reached via telephone, email, or through coordination with their clinic site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modest; 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; 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.
Experimental: Intensive; This approach is more robust, and requires a greater commitment of human resources.	Other: Intensive; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation data (sociodemographic and social needs survey)	Number of people completing the sociodemographic and social needs survey	Through study completion, up to 1 year
Implementation data (income screening question)	Number of people who answer positively to the income screening question	Through study completion, up to 1 year
Implementation data (income assistance indication)	Number of people who answer indicate they would like assistance with income	Through study completion, up to 1 year
Implementation data (recruitment and staff time)	Number of people recruited to the study; time required for staff to complete the Benefit Screening Tool and follow-up	Through study completion, up to 1 year
Implementation data (staff time)	Time required for staff to complete the Benefit Screening Tool and follow-up	Through study completion, up to 1 year
Patient self-reported stress as part of qualitative interview	Stress Levels (Never, Rarely, Sometimes, Often, Always)	2 months follow-up
Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire	Quality of Life (Excellent, Very Good, Good, Fair, Poor)	2 months follow-up

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): April 15, 2019
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Primary Care; Income; Social Needs; Sociodemographic Screening
• Other Study ID Numbers: Project ID 1532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No