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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. . |
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| Intensive | Experimental | This approach is more robust, and requires a greater commitment of human resources. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Patients: The inclusion criteria are as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew D Pinto, MD MSc | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's Family Health Team | Kingston | Ontario | K7L 5E9 | Canada | ||
| Platinum Medical Clinic |
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Intervention
Our intervention consists of two parts:
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| 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. |
|
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 |
| Scarborough Village |
| Ontario |
| M1J 2H3 |
| Canada |
| New Family Medicine Network, North York Family Health Team | Toronto | Ontario | M2K 2W2 | Canada |
| Southeast Toronto Family Health Team | Toronto | Ontario | M4C 5T2 | Canada |
| East End Community Health Centre | Toronto | Ontario | M4L 1G4 | Canada |
| Access Alliance | Toronto | Ontario | M6N 4B4 | Canada |