SPARK: Pilot Study

Study Overview
=================
Brief 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: 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

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

Conditions
-----------------
Primary Care

Intervention / Treatment
-----------------
* Other: Modest
* Other: Intensive


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention Our intervention consists of two parts: Routine screening for sociodemographics and social needs such as poverty 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modest<br>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. . | Other: Modest<br>* 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.<br>|
| Experimental: Intensive<br>This approach is more robust, and requires a greater commitment of human resources. | Other: Intensive<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sociodemographic Screening, Income, Primary Care, Social Needs