Clinical trial NCT04211025: Screening for Poverty and Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
Official title: Screening for Poverty and Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Care
Keywords: Sociodemographic Screening
Income
Primary Care
Social Needs
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: SCREENING

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

Eligibility criteria: 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

Primary outcomes:
measure: Access to Additional Benefits
timeFrame: 2 months follow-up
measure: Access to Additional Benefits
timeFrame: 4 months follow-up
Secondary outcomes:
measure: Implementation data (sociodemographic and social needs survey)
timeFrame: Through study completion, up to 1 year
measure: Implementation data (income screening question)
timeFrame: Through study completion, up to 1 year
measure: Implementation data (income assistance indication)
timeFrame: Through study completion, up to 1 year
measure: Implementation data (recruitment and staff time)
timeFrame: Through study completion, up to 1 year
measure: Implementation data (staff time)
timeFrame: Through study completion, up to 1 year
measure: Patient self-reported stress as part of qualitative interview
timeFrame: 2 months follow-up
measure: Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire
timeFrame: 2 months follow-up
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
city: Scarborough
country: Canada
facility: Platinum Medical Clinic
state: Ontario
city: Toronto
country: Canada
facility: New Family Medicine Network, North York Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: Southeast Toronto Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: East End Community Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Access Alliance
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Andrew D Pinto, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: