Screening for Poverty and Related Social Determinants and Intervening to Improve Knowledge of and Links to Resources (SPARK) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Access to Additional Benefits
研究概览
简要总结
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 .
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Access to Additional Benefits
时间窗: 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
次要结局
- Implementation data (sociodemographic and social needs survey)(Through study completion, up to 1 year)
- Implementation data (income screening question)(Through study completion, up to 1 year)
- Implementation data (income assistance indication)(Through study completion, up to 1 year)
- Implementation data (recruitment and staff time)(Through study completion, up to 1 year)
- Implementation data (staff time)(Through study completion, up to 1 year)
- Patient self-reported stress as part of qualitative interview(2 months follow-up)
- Patient self-reported quality of life on the PROMIS Global 10 Generic Health Questionnaire(2 months follow-up)