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临床试验/NCT03660631
NCT03660631进行中(未招募)不适用

Dissemination of the Cardiovascular Risk Service

Korey Kennelty27 个研究点 分布在 1 个国家目标入组 542 人开始时间: 2018年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
542
试验地点
27
主要终点
Factors influencing intervention implementation fidelity

研究概览

简要总结

The objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (CVRS) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients.

详细描述

Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. Yet effective implementation of research-based interventions that reduce CVD-related illness and death remains a substantial challenge. The objective of this study is to test the scalability of a pharmacist-led, remote CVD risk and prevention services model in large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients, using a pragmatic cluster-randomized design. This service is called the Cardiovascular Risk Service (CVRS). There are limited data on the barriers and facilitators of implementation to enhance the CVRS in these types of diverse, complex health-systems. Therefore, scaling up our effective, innovative team-based intervention will require an assessment of barriers and facilitators to CVRS adoption, implementation, and maintenance. Our central hypothesis is that barriers and facilitators to CVRS implementation will vary across diverse primary care offices. We will use mixed methods including interviews, observations, and an innovative physician-pharmacist collaboration survey we developed to predict implementation of pharmacy-based services. The rationale for this proposed study is that overcoming barriers to implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the US.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Patient Subjects:
  • English or Spanish speaking
  • Seen in the clinic at least once in the previous 12 months
  • Currently has one of the following diseases:
  • Diabetes with HA1c 9.0% or greater and/or
  • Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater

排除标准

  • Inability to give consent
  • Nursing home residence
  • No telephone
  • Additional patient subject exclusions:
  • Cancer with a life expectancy less than 24 months
  • Pregnancy
  • Diagnosis of dementia
  • Plans to terminate care from the clinic within 24 months

结局指标

主要结局

Factors influencing intervention implementation fidelity

时间窗: 12 months following the start of the intervention at each site

Themes will be identified through interviews with key individuals involved in implementation of study intervention. Data from interviews will be analyzed using ATLAS ti to determine frequency and density of themes identified in interviews.

Effect of physician/pharmacist collaboration on implementation fidelity

时间窗: 12 months following the start of the intervention at each site

Development of implementation fidelity measures and adherence to fidelity measures

次要结局

  • Reach and adoption of intervention(12 months following the start of the intervention at each site)
  • Development of payment contracts(36 months following the start of recruitment)
  • Adherence to guidelines for primary and secondary prevention of cardiovascular disease(12 months after the start of the intervention for each subject)

研究者

发起方
Korey Kennelty
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Korey Kennelty

Associate Professor

University of Iowa

研究点 (27)

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