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临床试验/NCT01241656
NCT01241656已完成不适用

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1

University of North Carolina, Chapel Hill4 个研究点 分布在 1 个国家目标入组 2,521 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,521
试验地点
4
主要终点
PSA test vs. No PSA test

研究概览

简要总结

In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design.

We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.

详细描述

We will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (DESI) with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical Foundation) and UNC. The primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. Secondary outcomes include the likelihood that they review the DESI and their decision-specific knowledge. The 3 strategies selected by the PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with a healthcare provider and other men; and (3) providing men options by inviting them to a SMA while also providing them a DESI in DVD which they can use individually if they are unable or choose not to attend a SMA. The 3 groups will be compared to a control condition that does not receive a DESI but will be encouraged to discuss prostate cancer screening with their physician. Because of its significantly larger patient population, the PAMF site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening.

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
Single (Participant)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • age 50 or older
  • do not have a prostate diagnosis
  • have not had a PSA test in the past 10 months
  • have not seen their primary care physicians in the last 3 months

排除标准

  • 未提供

结局指标

主要结局

PSA test vs. No PSA test

时间窗: 12 month follow-up

We will determine whether a DESI viewing had an impact on testing.

Healthcare utilization and costs

时间窗: 12 month follow-up

All prostate specific health care utilization and cost will be estimate for each group.

次要结局

  • Decision specific knowledge(4 months after mailings)
  • Discussion with provider(4 months after mailings)
  • DESI viewing(4 months after mailings)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmen Lewis, MD, MPH

Associate Professor

University of North Carolina, Chapel Hill

研究点 (4)

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