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临床试验/NCT05022316
NCT05022316已完成不适用

COHERE - COntextualized Care in cHcs' Electronic Health REcords

Kaiser Permanente6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
6
主要终点
diabetes control

研究概览

简要总结

This study was designed to develop and test clinical decision support (CDS) tools that present clinical care team members with a given patient's social risk information and recommend care plan adaptations based on those risks. This study will test the hypothesis that providing care team members with CDS about patients' known social risks will result in improved outcomes. This study's primary outcomes are hypertension and diabetes control, but the results will have implications for a wide range of morbidities.

详细描述

The investigators will use a randomized quasi-experimental design to assess impact of the CDS tools designed to support social risk-informed care. After conducting a 12-month pilot study with 3 CHCs to test and further refine the CDS tools, 6 CHCs will be recruited to participate in the main trial. All OCHIN clinics with >200 SDH screenings (excluding the pilot clinics) will be identified and randomized to a potential intervention group or a control group. Clinics from the potential intervention group will be recruited in a random order until 6 agree to participate. This recruitment method ensures randomization between intervention and control clinics, without recruiting CHCs to a study in which they might not receive an intervention. Intervention sites will be trained in how to use the tools shortly before the tools are activated and will be followed for 12 months to assess tool adoption and impact on the CQMs of interest. Use of the CDS tools will occur as part of the regular care patients receive and will not require special clinic visits. Patients will interact with providers as they normally would, augmented by the intervention when clinicians choose to utilize the CDS tools. For all study clinics, quantitative data will be collected (via EHR data extraction) on social risk data collection and action by care team members. Limited clinical data will be collected on patients who are seen at a study CHC during the study period. Qualitative data will also be collected which includes semi-structured interviews with clinic staff from all study CHCs enrolled in the main trial.

NOTE: Individual patients will not be assigned to an intervention. Instead, randomization and intervention will occur at the clinic level. While CHCs will be recruited that have previously screened patients for social risks, it is unlikely that these CHCs will have screened all patients in their clinics. Thus, the CDS tools will not apply to all patients in participating clinics, and it cannot be guaranteed that individual patients will receive an intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Clinic has conducted >200 social risk screenings in the last 12 months at the time of randomization.
  • Clinic provides primary care
  • Joined OCHIN by 07/01/2021

排除标准

  • Clinic participated in pilot
  • Clinic is a school-based health center
  • Clinic provides care to prison population

结局指标

主要结局

diabetes control

时间窗: 12 months

binary outcome of patient with diabetes having an HbA1c of \<9% at the time of the clinic visit (0=no, 1=yes)

hypertension control

时间窗: 12 months

binary outcome of patient having a blood pressure of \<140/90 at the time of the clinic visit (0=no, 1=yes)

次要结局

  • completion of medication adherence documentation(12 months)
  • completion of social risk screening(12 months)
  • SDH z-codes added to problem list and/or visit list(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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