Screening for Poverty and Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
- Conditions
- Primary Care
- Interventions
- Other: ModestOther: Intensive
- Registration Number
- NCT04211025
- Lead Sponsor
- Unity Health Toronto
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
Patients: The inclusion criteria are as follows:
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modest 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. . Intensive Intensive This approach is more robust, and requires a greater commitment of human resources.
- Primary Outcome Measures
Name Time Method Access to Additional Benefits 4 months follow-up 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
- Secondary Outcome Measures
Name Time Method Implementation data (income assistance indication) Through study completion, up to 1 year Number of people who answer indicate they would like assistance with income
Implementation data (recruitment and staff time) Through study completion, up to 1 year Number of people recruited to the study; time required for staff to complete the Benefit Screening Tool and follow-up
Implementation data (sociodemographic and social needs survey) Through study completion, up to 1 year Number of people completing the sociodemographic and social needs survey
Implementation data (income screening question) Through study completion, up to 1 year Number of people who answer positively to the income screening question
Implementation data (staff time) Through study completion, up to 1 year Time required for staff to complete the Benefit Screening Tool and follow-up
Patient self-reported stress as part of qualitative interview 2 months follow-up Stress Levels (Never, Rarely, Sometimes, Often, Always)
Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire 2 months follow-up Quality of Life (Excellent, Very Good, Good, Fair, Poor)
Trial Locations
- Locations (6)
Queen's Family Health Team
🇨🇦Kingston, Ontario, Canada
Platinum Medical Clinic
🇨🇦Scarborough, 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