SPARK: Pilot Study

Primary Care Clinical Trial

Official title: Screening for Poverty And Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study

Status Recruiting

Clinical Trial 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 .

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Primary Care

• NCT number: NCT04211025
• Study type: Interventional
• Source: St. Michael's Hospital, Toronto
• Contact: Anne Rucchetto, MPH
• Phone: 416-864-6060
• Email: rucchettoa@smh.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Completion date: March 25, 2020