Trials / Completed
CompletedNCT04211025
Screening for Poverty and Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
Screening for Poverty and Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Unity Health Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | 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. |
Timeline
- Start date
- 2019-04-15
- Primary completion
- 2021-01-15
- Completion
- 2021-01-29
- First posted
- 2019-12-26
- Last updated
- 2025-01-31
Locations
6 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04211025. Inclusion in this directory is not an endorsement.