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Completed

NCT Number: NCT04211025

Screening for Poverty and Related Social Determinants 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:

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 .

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Key information

Conditions

Primary Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's Family Health Team, Kingston, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Modest

Other

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

Other

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Implementation data (sociodemographic and social needs survey)

    Time frame: Through study completion, up to 1 year

    Number of people completing the sociodemographic and social needs survey

  2. Implementation data (income screening question)

    Time frame: Through study completion, up to 1 year

    Number of people who answer positively to the income screening question

  3. Implementation data (income assistance indication)

    Time frame: Through study completion, up to 1 year

    Number of people who answer indicate they would like assistance with income

  4. Implementation data (recruitment and staff time)

    Time frame: 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

  5. Implementation data (staff time)

    Time frame: Through study completion, up to 1 year

    Time required for staff to complete the Benefit Screening Tool and follow-up

  6. Patient self-reported stress as part of qualitative interview

    Time frame: 2 months follow-up

    Stress Levels (Never, Rarely, Sometimes, Often, Always)

  7. Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire

    Time frame: 2 months follow-up

    Quality of Life (Excellent, Very Good, Good, Fair, Poor)

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Acronym: SPARK Pilot

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2019
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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