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

NCT ID: NCT04211025

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2021-01-29

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. 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 .

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

Conditions

Primary Care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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. .

Group Type: EXPERIMENTAL

Modest

Intervention Type: 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.

Intensive

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

Group Type: EXPERIMENTAL

Intensive

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew D Pinto, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

Queen's Family Health Team

Kingston, Ontario, Canada

Platinum Medical Clinic

Scarborough Village, Ontario, Canada

New Family Medicine Network, North York Family Health Team

Toronto, Ontario, Canada

Southeast Toronto Family Health Team

Toronto, Ontario, Canada

East End Community Health Centre

Toronto, Ontario, Canada

Access Alliance

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Project ID 1532

Identifier Type: -

Identifier Source: org_study_id