Community Health Workers Systematically Assessing and Addressing Social Determinants of Health to Improve Outcomes in Community Health Centers (CHW-SYSTIM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72,726
- 试验地点
- 3
- 主要终点
- Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention
研究概览
简要总结
The goal of this mixed-methods study is to assess the impact of a Community Health Worker (CHW)-led social risk screening and referral in improving management of uncontrolled diabetes (DM) and hypertension (HTN) among patients receiving care in community health centers (CHCs or health centers). The intervention is focused on adult health center patients with uncontrolled DM and/or HTN. Study findings will provide important evidence to guide CHCs in implementing programs to address social risks in their patient populations. Findings will illuminate whether and how CHW-led interventions to address social needs yield the hypothesized outcomes. The aims of the study are:
- AIM 1: Measure how effective the CHW-led social risk program is at reducing blood sugar levels (A1C) in CHC patients with uncontrolled DM and lowering blood pressure in CHC patients with uncontrolled HTN.
- AIM 2: Identify effective strategies for increasing and expanding CHW-led social risk programs.
详细描述
BACKGROUND: Social determinants of health (SDOH) are the conditions of the environment in which people are born, live, work, and age; they are non-medical factors that impact health. Adverse SDOH are often called social risks; when patients report having such risks and desiring strategies for mitigating them, it is often called social needs. Exposure to social risks contributes to numerous poor health outcomes and is associated with negative impacts on chronic disease outcomes like diabetes (DM) and hypertension (HTN) control.
People with HTN have high rates of social risks, and these rates are higher among African American, Alaskan Native, American Indian, Native Hawaiian and Pacific Islander patients than white patients. Social risks often occur in clusters, and patients with multiple social risks are more likely to have uncontrolled DM and / or uncontrolled HTN. Given the many negative health impacts of social risks, numerous national guidelines recommend screening for and addressing social risks through referral to social services. The impacts of social risks on DM and HTN outcomes are most profound in the communities served by community health centers (CHCs). CHC patients with DM have high rates of unmet social needs. Therefore, the need for interventions that mitigate the impacts of social risks on these chronic disease outcomes - and the need for evidence on how to implement such interventions effectively and sustainably - is critical in the CHC setting.
Many CHCs strive to assess and address social risks but lack an approach to doing so systematically; as a result, not all patients who could benefit from such efforts - such as those with uncontrolled DM and / or HTN - do so. The many known barriers to widespread adoption of systematic social risk screening and referral-making include challenges associated with fitting social risk screening, documentation, and referral-making into clinic workflows.
Preliminary evidence suggests that Community Health Workers (CHWs) could play a critical part in CHC approaches to identifying social risks and referring patients with social needs to social services. CHW models of care have been shown to have a significant and positive impact on health outcomes, including hospitalization readmission rates and continuity of care. Thus, CHW-based approaches in CHCs might mitigate the impacts of social risks on DM and HTN. However, given the substantial barriers to implementing social risk-related activities in clinical settings, research is needed on how to optimize CHW-focused social risk interventions, and how to implement such interventions so they are adopted systematically and sustainably. Yet there are barriers specific to CHWs' potential ability to support CHCs' social risk efforts, including CHWs' large caseloads, competing demands, and time pressure, limited ability to enter data in the electronic health record, and CHWs lacking needed information to connect patients with social services. Thus, there is a clear need for research on: the impact on DM and HTN outcomes of CHW-led interventions to address social risks, whether and how CHW-led interventions support implementing this model in CHCs, and strategies for enhancing the sustained implementation of CHW-led interventions in this setting. The proposed study will generate some of this needed evidence.
SETTING: The RCT will be conducted in CHCs. NCPCR, comprised of two research networks (OCHIN, Morehouse School of Medicine (MSM)), will engage three primary care networks (OCHIN, Health Choice Network (HCN), and the Southeast Regional Clinicians Network (SERCN)) and these existing networks will be leveraged to recruit CHCs to participate in the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •18 years or older
- •People with Type 2 diabetes with their most recent hemoglobin A1c test result (a blood test that reflects average blood sugar levels over the past 2-3 months) is greater than or equal to 9%.
- •People with essential hypertension with their last systolic blood pressure (BP) (the top number in a BP reading) is greater than or equal to 140 mmHg or diastolic BP (the bottom number in a BP reading) is greater than or equal to 90 mmHg.
排除标准
- •People who are less than 18 years old
- •Pregnant people
- •People who don't meet the Type 2 diabetes or hypertension criteria.
研究组 & 干预措施
Control Community Health Centers
Control CHC data on enabling services and associated workflows will be gathered through qualitative methods for a deeper understanding of the intervention impact. At the end of the intervention year, control CHCs will receive: (1) participation in the end of intervention summative CHW convening for crossover training led by the intervention arm CHWs; and 2) a toolkit designed to support their adoption of the intervention processes. This will both support the dissemination of intervention elements identified as effective (as feasible), and recruitment activities (by ensuring that all study FQHCs receive something through study participation).
Intervention Community Health Centers
Community Health Centers (CHC) will identify a Community Health Worker (CHW) or similar staff member who will conduct social risk activities as part of clinical services for all CHC patients with uncontrolled diabetes (DM) and hypertension (HTN) as defined by Uniform Data System (UDS). If needed due to resource constraints, a prioritization scheme may be applied to target patients with the most poorly controlled DM / HTN, those newly diagnosed, those at selected CHC-run sites, etc.; this scheme will be refined in the intervention development phase.
干预措施: CHC-level cluster randomized control trial (Other)
结局指标
主要结局
Test the hypothesis that CHW-led process will improve health outcomes among DM patients post 12 month intervention
时间窗: Measured at 6 months and 12 months after the first CHW contact.
Percentage of participants with a clinically significant improvement in HbA1c, defined as ≥0.5% improvement in HbA1c
Test the hypothesis that CHW-led process will improve health outcomes among HTN patients post 12 month intervention
时间窗: Measured at 6 months and 12 months after the first CHW contact.
Percentage of participants with a clinically significant improvement in blood pressure, defined as either a ≥5 mmHg reduction in systolic BP, a ≥3 mmHg reduction in diastolic BP, or a return to normal BP (BP \<140/90, requiring both systolic and diastolic values below threshold).
次要结局
- Biomarker Screening(New BP measure documented ≥3 months after first contact with the CHW.)
- Biomarker Screening(New HbA1c measure documented ≥6 months after first contact with the CHW.)
- Referral provided and completed(Assessed at 6 months after first CHW contact.)
- Referral provided and completed(Assessed at 12 months after first CHW contact.)
- Referral impact on social risk(Assessed at 6 months after first CHW contact.)
- Referral impact on social risk(Assessed during and after study completion (up to 12 months after the first CHW contact))
