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Understanding and Discouraging Overuse of Potentially Harmful Screening Tests

2016年4月15日 更新者:Stacey Sheridan, MD、University of North Carolina, Chapel Hill

Most prevention efforts focus on promoting services (e.g. vaccination, screening tests). While some of these services have clear net benefit, many instead have possible or clear net harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are delivered in healthcare settings at higher rates than what might be expected based on their potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to deliver more quality care. An important issue in delivering prevention messages is how to shift toward a focus on the appropriateness of prevention: encouraging services with clear net benefit and either discouraging or reducing demand for services with possible or clear net harm. Unfortunately, little is known about what drives overuse of potentially harmful screening services or how to make harms relevant to patients.

This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1) assess factors associated with intent to receive possibly or clearly harmful screening services and 2) determine whether and how patients' plans to get screened change with various presentations of information about harms (e.g. qualitative, quantitative, narrative, framed). The investigators will focus on three types of screening services: osteoporosis screening (previous C recommendation and now no recommendation for women < 65 years old with no fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).

研究概览

研究类型

介入性

注册 (实际的)

775

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • North Carolina
      • Durham、North Carolina、美国、27704
        • Duke Primary Care Research Consortium

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Women between ages 50 to 85
  • Men between ages 50 to 85
  • Eligible for exemplar service of interest (see below for specifics of inclusion/exclusion for specific services)

Exclusion Criteria:

  • Current treatment of psychosis
  • History of alcohol or substance abuse within the last 2 years
  • Dementia or other severe cognitive dysfunction
  • serious medical illnesses with a life expectancy of less than 2 years (e.g., metastatic cancer)
  • inability to speak and understand English
  • blindness
  • presentation for an acute medical visit
  • no telephone number

Osteoporosis Screening (women aged 50-64)

Exclusion Criteria:

  • a personal history of osteoporosis
  • a personal history of moderate or severe osteopenia
  • BMI (body mass index) < 18.5
  • personal history of non-traumatic fracture
  • family history of hip fracture
  • current smoking
  • current use of prednisone (>30 consecutive days)
  • alcohol use of 3 or more drinks/day.

Prostate Cancer screening (men aged 50-69)

Exclusion Criteria:

  • a prior history of prostate cancer

Colorectal Cancer Screening (men and women aged 76-85)

Exclusion Criteria:

  • prior history of colorectal cancer
  • adenomatous colon polyps > 6mm (or 2 or more < 6mm)
  • symptoms referable to colorectal cancer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Quantitative
In the quantitative arm, we will present harms as absolute risks in the Quantitative Information Sheet. Compared with other risk formats, absolute risks have been shown to improve understanding relative to other common risk formats.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the quantitative information sheet, harms will be communicated in absolute risks with accompanying fact box (i.e. box containing key facts and rates). In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and the screening test, a description of the possible benefits of the service, and a statement encouraging decision. As an adjunct to numerical information in paragraph form, fact boxes engage individuals to process information and improve understanding.
有源比较器:Qualitative
In the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the qualitative information sheet, harms will be communicated using verbal descriptors. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
实验性的:Narrative
In the narrative arm, we will present harms using patient narratives (i.e. descriptions in which patients describe their experience with decision making about potentially harmful screening services)in the Narrative Information Sheet. To address concerns in the literature that characteristics of the narrator independently influence narrative effect, we will present narratives in paper format with a banner of culturally diverse age-appropriate pictures shown at the top.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the narrative information sheet, harms will be communicated using patient narratives with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
实验性的:Framed
In the framed arm, we will frame not screening with potentially harmful services as beneficial (i.e. use a gain frame). In the Framed Information Sheet, we will highlight the harms that could be avoided by not getting screened.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the framed information sheet, harms will be communicated using a gain frame (as described in the arm section above) with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline in Intent to Accept Screening Immediately Post-intervention
大体时间:Pre and Post Intervention (same visit - Day 1)
Following the example of others, we will measure intent to accept screening services with possible or clear net harm with a single item "I plan to get screened for (name of screening test) in the next year." Because the recommended screening intervals for services under study are variable and not all participants will be due for screening in the next year, we will additionally query participants about plans for screening within the recommended screening interval (e.g. osteoporosis screening--5 years; CRC--10 years). Responses will range from "strongly disagree" to strongly agree". All outcomes will be measured before and after participants receive the information sheet. All data will be collected at the one study visit.
Pre and Post Intervention (same visit - Day 1)

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline in Perceived Disease Risk Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)
Perceived risk or susceptibility of disease will be measured for each disease state under study using one item that reads, "How likely is that you will get (insert prostate cancer, osteoporosis, or colon cancer) in the next 10 years?" Answers will be on a likert scale from "not at all likely" to "very likely."
Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Perceived Disease Severity Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)
Perceived Disease Severity will be measured for each disease state under study using the Revised Illness Perceptions Questionnaire for Healthy People. It includes the following four questions: 1) x (insert prostate cancer, osteoporosis, or colon cancer) has serious financial consequences; 2) x strongly affects the way the patient sees himself as a person; 3) x causes difficulties to those close to the patient; 4) x is very serious. Answers will be on a 5-point scale from "strongly disagree" to "strongly agree."
Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)

Two questions central to understanding each exemplar service (i.e. prostate cancer screening, osteoporosis screening, colon cancer screening) were selected to assess specific knowledge. Response options include true, false, or don't know.

Questions for prostate cancer screening are:

  1. Some men can live long, normal lives with untreated prostate cancer.
  2. Problems with sexual function and urination are common side effects of prostate cancer treatments.

Questions for colon cancer screening are:

  1. Most polyps in the bowel never become cancer.
  2. Bleeding and perforations are complications of a colonoscopy.

Questions for Osteoporosis screening are:

  1. Broken hip bones are uncommon before age 65.
  2. Treatments for osteoporosis can sometimes result in bone damage.
Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)

Six questions will assess participants' attitudes about each screening service under study.

Questions include:

  1. Screening for x(insert prostate cancer, colon cancer, osteoporosis) in healthy persons my age is a good idea.
  2. There is little harm to screening for x.
  3. I owe it to people close to me to get screened for x.
  4. I owe it to my doctor to get screened for x.
  5. I would regret not being screened for x.
  6. I do not feel any special responsibility to get screened for x.

Response options range from "strongly disagree" to "strongly agree".

Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Decisional Balance Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)
Decisional balance will be measured by a single item for each screening service under study. Participants will be asked, "Which best describes how you feel right now?" Participants will select one of the following answers: 1) The benefits of X (insert prostate cancer, colon cancer, osteoporosis) screening greatly outweigh the harms; 2) The benefits of X screening somewhat outweigh the harms; 3) The benefits and harms of X screening are about the same; 4) The harms of X screening somewhat outweigh the benefits; and 5) The harms of X screening greatly outweigh the benefits.
Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Values Clarity Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)

Values Clarity will be measured with three items for the values subscale of the decisional conflict scale.

Items include:

  1. I am clear about which benefits matter most to me;
  2. I am clear about which harms and side effects matter most to me;
  3. I am clear about which is more important to me (the benefits or the harms);

Response options range from strongly disagree to strongly agree.

Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Knowledge Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1)

General screening knowledge will be assessed using 8 items developed by investigators.

Questions include:

  1. Screening means detecting disease before someone can see or feel any problem.
  2. Some diseases detected by screening won't cause any problems in a person's lifetime.
  3. In some cases, screening can lead to treatment that is not necessary.
  4. Screening never harms anyone.
  5. An abnormal screening test means I have the health condition for sure.
  6. A normal screening test means that I have am free of the health condition for sure.
  7. Screening can only decrease your chances of getting sick or dying if effective treatments are available.
  8. Screening can only decrease your chances of getting sick or dying if you live long enough for treatments to work.

Response options are true, false, or don't know.

Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Attitudes Immediately Post-Intervention
大体时间:Pre and Post Intervention (same visit - Day 1))

General Screening Attitudes will be assessed at baseline by 38 questions that were developed by investigators and assessed for content validity by panel of experts. Questions assess the following sub-constructs:

General approach to screening, Value of Screening, Need to Know about Disease, Early Detection/Treatment, Benefits, Harms, Anticipated Regret in Choosing for/against screening, Duty/Responsibility to be screened, Effect on screening on MD/patient relationship.

Response options range from "strongly disagree" to "strongly agree" on a 5-point scale.

At post intervention, a subset of 12 of the 38 questions (1-2 from each subconstruct) will be used to assess changes in general screening attitudes.

Pre and Post Intervention (same visit - Day 1))

其他结果措施

结果测量
措施说明
大体时间
Key moderating variables
大体时间:pre-intervention

Multiple variables will be measured to examine whether they moderate the effect of the intervention on the primary outcome intent for screening.

These variables include:

  1. self-efficacy for screening (1 question)
  2. cues to action (6-questions on sources of health information)
  3. perceived ambiguity of recommendations for screening (1 question)
  4. personality traits (10-item personality index)
  5. optimism (3 question subscale of life orientation test)
  6. need for cognition (3 items from need for cognition scale)
  7. health numeracy (3 items from Schwarz and Woloshin numeracy score)
  8. prior screening status (1 item per service)
  9. study site
  10. health insurance status
pre-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Stacey Sheridan, MD、University of North Carolina, Chapel Hill

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年9月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2012年9月13日

首先提交符合 QC 标准的

2012年9月26日

首次发布 (估计)

2012年9月27日

研究记录更新

最后更新发布 (估计)

2016年4月19日

上次提交的符合 QC 标准的更新

2016年4月15日

最后验证

2016年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 12-1338

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