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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211025
• Other study ID #: Project ID 1532
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: December 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Anne Rucchetto, MPH
• Phone: 416-864-6060
• Email: rucchettoa[@]smh.ca
• Is FDA regulated: No
• Study type: Interventional

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 .

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 25, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Primary Care

Intervention

Other:
• Modest
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.
• Intensive
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.

Locations

Country	Name	City	State
Canada	Queen's Family Health Team	Kingston	Ontario
Canada	Platinum Medical Clinic	Scarborough	Ontario
Canada	Access Alliance	Toronto	Ontario
Canada	East End Community Health Centre	Toronto	Ontario
Canada	New Family Medicine Network, North York Family Health Team	Toronto	Ontario
Canada	Southeast Toronto Family Health Team	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Implementation data	Number of people completing the sociodemographic and social needs survey	Through study completion, up to 1 year
Secondary	Implementation data	Number of people who answer positively to the income screening question	Through study completion, up to 1 year
Secondary	Implementation data	Number of people who answer indicate they would like assistance with income	Through study completion, up to 1 year
Secondary	Implementation data	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
Secondary	Implementation data	Time required for staff to complete the Benefit Screening Tool and follow-up	Through study completion, up to 1 year
Secondary	Patient self-reported outcomes	Stress Levels	2 months follow-up
Secondary	Patient self-reported outcomes	Quality of Life	2 months follow-up
Secondary	Patient self-reported outcomes	Stress levels	4 months follow-up
Secondary	Patient self-reported outcomes	Quality of life	4 months follow-up