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临床试验/NCT06489002
NCT06489002进行中(未招募)不适用

DEDICATE: aDvancing carE Management aDoption In Community heAlTh cEnters

OCHIN, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
OCHIN, Inc.
入组人数
20
试验地点
1
主要终点
Social needs screening

研究概览

简要总结

DEDICATE will refine and test the effectiveness of evidence-based implementation support strategies designed to support care management teams' sustained use of electronic health record (EHR)-based functionalities to address unmet non-medical health-related needs through improved clinical-community linkages. This study will test the hypothesis that providing implementation support to health center care management teams will lead to increased adoption of EHR functionalities and increased screenings and referrals to community organization to address unmet non-medical health-related needs needs through a cluster-randomized trial. This study's results will have implications for patients with non-medical health-related needs receiving care management in primary care settings.

详细描述

The investigators will use a hybrid effectiveness-implementation mixed methods design to assess the impact of evidence-based implementation support strategies designed to support the care management teams' adoption of EHR functionalities that enable screening and referrals to community organizations for non-medical health-related needs. After conducting a three-month pilot study with three health centers to test and refine the implementation support strategies, 20 community-based health centers will be recruited to participate in a stepped-wedge, cluster-randomized trial. Eligible OCHIN health centers include those that provide primary care, use an EHR-based care management tool for at least one care management or population health program that addresses non-medical health-related needs for more than 10 enrolled patients from April-June 2025. Once 20 health centers have been enrolled, health centers will be randomized to one of four wedges for staggered receipt of the intervention. This method will allow us to provide tailored support to five health centers at a time and enables all health centers to eventually receive the intervention. Participating sites will be provided implementation support strategies for using EHR-based functionalities to conduct screening and referrals for patients with unmet non-medical health-related needs. After receiving the intervention, participating health centers will be followed until Y4Q4 to assess primary and secondary outcomes.

The intervention includes implementation strategies to support adoption of EHR-based functionalities for non-medical health-related needs activities by care management teams in health centers. The intervention will be delivered to health center care management staff outside of patient care. Patients will not directly receive the intervention and will continue to receive regular care from the health center. For all study health centers, quantitative data will be collected (via EHR data extraction) on care team use of EHR functionalities and non-medical health-related needs screening and coordination provided by care teams. Limited clinical data will be collected on patients seen at included health centers during the study period. Qualitative data will also be collected, including semi-structured interviews with clinic staff from all enrolled study sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • • Health centers that use an EHR-based care management tool for at least one care management or population health program that addresses non-medical health-related needs for more than 10 enrolled patients from April-June 2025.

排除标准

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

研究组 & 干预措施

Intervention Arm

Experimental

Intervention health centers will receive implementation support when they crossover from Control to Intervention.

干预措施: Implementation Support (Other)

Control Arm

No Intervention

Control health centers will not receive an intervention prior to crossover to Intervention.

结局指标

主要结局

Social needs screening

时间窗: From six months prior to the intervention, assessed up to 12 months.

Binary variable of whether the patient has been screened for social needs

Social needs referral

时间窗: From six months prior to the intervention, assessed up to 12 months.

Binary variable of whether patients with unmet social needs received referrals to a community organization

Screening for non-medical health-related needs

时间窗: From six months prior to the intervention, assessed up to 12 months.

Whether a patient enrolled in a care management program was screened for unmet non-medical health-related needs (binary, patient-level).

Referral for non-medical health-related need

时间窗: Baseline, through study completion, an average of 7.5 months.

Among patients with one or more identified non-medical health-related need, whether a referral was made for each identified need (binary, patient-level)

次要结局

  • Community-based services receipt for referred social needs(From six months prior to the intervention, assessed up to 12 months.)
  • Controlled hypertension(From six months prior to the intervention, assessed up to 12 months.)
  • Controlled type 2 diabetes mellitus(From six months prior to the intervention, assessed up to 12 months.)
  • Referrals with a documented outcome (all non-medical health-related needs)(Baseline, through study completion, an average of 7.5 months.)
  • Referrals with an outcome documented as received (all non-medical health-related needs)(Baseline, through study completion, an average of 7.5 months.)
  • Controlled hypertension(Baseline, through study completion, an average of 7.5 months.)
  • Controlled type 2 diabetes mellitus(Baseline, through study completion, an average of 7.5 months.)

研究者

发起方
OCHIN, Inc.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicole Cook

Principal Investigator

OCHIN, Inc.

研究点 (1)

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