跳至主要内容
临床试验/NCT01484665
NCT01484665已完成不适用

Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening

University of Minnesota1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2011年12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
已完成
入组人数
72
试验地点
1
主要终点
Provider Satisfaction with Implementation of the Shared Decision Making Process

研究概览

简要总结

Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.

详细描述

This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.

After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

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
是

入选标准

  • •Males ages 50-75
  • •Able to read and speak English
  • •Provide written informed consent

排除标准

  • •Diagnosis of prostate cancer
  • •PSA testing within last 12 months
  • •Previous prostate biopsy
  • •Voiding problems as reason for clinic visit
  • •Visit scheduled same day or 'walk-In' patient

研究组 & 干预措施

Participants (Males, age 50-75 yrs)

Experimental

Eligible men will be identified from the administrative database and electronic medical record at the University of Minnesota (EMR) at least 24 hours prior to the clinic visit. They will be asked to complete the PROCASE Decision-Aid.

干预措施: PROCASE Decision-Aid (Other)

结局指标

主要结局

Provider Satisfaction with Implementation of the Shared Decision Making Process

时间窗: At 8-10 Months

Will be determined through a combination of surveys and responses to questions derived during focus groups.

Provider Satisfaction with Implementation of the Shared Decision Making Process

时间窗: At 3-5 Months

Will be determined through a combination of surveys and responses to questions derived during focus groups.

次要结局

  • Patient Satisfaction with Shared Decision Making and Reach of the Intervention(At 3-5 Months)
  • Patient Satisfaction with Shared Decision Making and Reach of the Intervention(At 8-10 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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