Primary Care
Conditions
Keywords
Sociodemographic Screening, Income, Primary Care, Social Needs
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
Interventions
OTHERModest
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.
OTHERIntensive
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.
Sponsors
Unity Health Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Intervention Our intervention consists of two parts: 1. Routine screening for sociodemographics and social needs such as poverty 2. Intervening when poverty is identified through linkage to a trained staff member who uses a Benefits Screening Tool to identify benefits that the patient is entitled to, and then provides support
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Access to Additional Benefits | 2 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (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 |
| 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) |
| Implementation data (staff time) | Through study completion, up to 1 year | Time required for staff to complete the Benefit Screening Tool and follow-up |
Countries
Canada
Outcome results
None listed