Primary CareSPARK PilotNCT04211025
Screening for Poverty and Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
A study testing Modest and Intensive in people with Primary Care, run by Unity Health Toronto at 6 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Care
- What is being tested?
- Modest and Intensive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesCanada
- Study dates
- 15 Apr 2019to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients: The inclusion criteria are as follows:
- A patient who completed the sociodemographic and social needs survey in their primary care organization.
- 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?"
- Able to provide consent
- Age is greater than or equal to 18
- Able to converse in English
- Able to be reached via telephone, email, or through coordination with their clinic site
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Queen's Family Health Team
Kingston, Ontario, K7L 5E9
Platinum Medical Clinic
Scarborough Village, Ontario, M1J 2H3
New Family Medicine Network, North York Family Health Team
Toronto, Ontario, M2K 2W2
Southeast Toronto Family Health Team
Toronto, Ontario, M4C 5T2
East End Community Health Centre
Toronto, Ontario, M4L 1G4
Access Alliance
Toronto, Ontario, M6N 4B4
About this study
Official title: Screening for Poverty and Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
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:
- to collect data on the feasibility of recruiting clinics for a large cluster randomized controlled trial (RCT)
- 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
- collect data on the acceptability and feasibility of "modest" and "intensive" interventions on poverty (discussed below)
- collect data on the recruitment rate of patients, to assist with calculating the sample size for a larger cluster RCT
- 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 .
Read the 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
- Conditions
- Primary Care
- Being tested
- Modest, Intensive
- Keywords
- Sociodemographic Screening, Income, Primary Care, Social Needs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModestOther
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.
IntensiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Modest | Experimental | This approach is feasible to integrate into workflows of a wide-range of clinics, and should have a minimal impact on human resources. Materials and strategies to support staff in this work will be provided. . Receives: Other: Modest |
| Intensive | Experimental | This approach is more robust, and requires a greater commitment of human resources. Receives: Other: Intensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months follow-up
Secondary outcomes (7)
Implementation data (sociodemographic and social needs survey)
Number of people completing the sociodemographic and social needs survey
Measured: Through study completion, up to 1 year
Implementation data (income screening question)
Number of people who answer positively to the income screening question
Measured: Through study completion, up to 1 year
Implementation data (income assistance indication)
Number of people who answer indicate they would like assistance with income
Measured: 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
Measured: Through study completion, up to 1 year
Implementation data (staff time)
Time required for staff to complete the Benefit Screening Tool and follow-up
Measured: Through study completion, up to 1 year
Patient self-reported stress as part of qualitative interview
Stress Levels (Never, Rarely, Sometimes, Often, Always)
Measured: 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)
Measured: 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start15 Apr 2019
- Primary completion15 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary CareStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Pinto, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211025
- Sponsor's protocol ID
- Project ID 1532
- Acronym
- SPARK Pilot
- Status last verified
- Dec 2019
- First submitted
- 28 May 2019
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Poverty and Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
- ClinicalTrials.gov ID
- NCT04211025
- Acronym / sponsor ID
- SPARK Pilot / Project ID 1532
- Conditions
- Primary Care
- Keywords
- Sociodemographic Screening, Income, Primary Care, Social Needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to collect data on the feasibility of recruiting clinics for a large cluster randomized controlled trial (RCT)
- 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
- collect data on the acceptability and feasibility of "modest" and "intensive" interventions on poverty (discussed below)
- collect data on the recruitment rate of patients, to assist with calculating the sample size for a larger cluster RCT
- 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
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Modest | Experimental | Other: ModestThis approach is feasible to integrate into workflows of a wide-range of clinics, and should have a minimal impact on human resources. Materials and strategies to support staff in this work will be provided. . |
| Intensive | Experimental | Other: IntensiveThis approach is more robust, and requires a greater commitment of human resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A patient who completed the sociodemographic and social needs survey in their primary care organization.
- 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?"
- Able to provide consent
- Age is greater than or equal to 18
- Able to converse in English
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModestThe 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. | Other | Modest |
| IntensiveThe 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. | Other | Intensive |
Primary outcome
Access to Additional Benefits
Time frame: 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
Access to Additional Benefits
Time frame: 4 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
7 secondary outcomes
Implementation data (sociodemographic and social needs survey)
Time frame: Through study completion, up to 1 year
Implementation data (income screening question)
Time frame: Through study completion, up to 1 year
Implementation data (income assistance indication)
Time frame: Through study completion, up to 1 year
Implementation data (recruitment and staff time)
Time frame: Through study completion, up to 1 year
Implementation data (staff time)
Time frame: Through study completion, up to 1 year
Patient self-reported stress as part of qualitative interview
Time frame: 2 months follow-up
Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire
Time frame: 2 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Pinto, MD MSc principal investigator
Unity Health Toronto
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modest and Intensive in people with Primary Care, run by Unity Health Toronto at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to Additional Benefits (time frame: 2 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.