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 .
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
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
75
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.
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.
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
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
Time frame: 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
Time frame: 4 months follow-up
Implementation data (sociodemographic and social needs survey)
Number of people completing the sociodemographic and social needs survey
Time frame: Through study completion, up to 1 year
Implementation data (income screening question)
Number of people who answer positively to the income screening question
Time frame: Through study completion, up to 1 year
Implementation data (income assistance indication)
Number of people who answer indicate they would like assistance with income
Time frame: 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
Time frame: Through study completion, up to 1 year
Implementation data (staff time)
Time required for staff to complete the Benefit Screening Tool and follow-up
Time frame: Through study completion, up to 1 year
Patient self-reported stress as part of qualitative interview
Stress Levels (Never, Rarely, Sometimes, Often, Always)
Time frame: 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)
Time frame: 2 months follow-up
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