跳至主要内容
临床试验/NCT01694784
NCT01694784已完成不适用

Understanding and Discouraging Overuse of Potentially Harmful Screening Tests

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 775 人开始时间: 2012年9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
775
试验地点
1
主要终点
Change from Baseline in Intent to Accept Screening Immediately Post-intervention

研究概览

简要总结

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

Quantitative

Experimental

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.

干预措施: Quantitative Information Sheet (Behavioral)

Qualitative

Active Comparator

In the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet.

干预措施: Qualitative Information Sheet (Behavioral)

Narrative

Experimental

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.

干预措施: Narrative Information Sheet (Behavioral)

Framed

Experimental

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.

干预措施: Framed Information Sheet (Behavioral)

结局指标

主要结局

Change from Baseline in Intent to Accept Screening Immediately Post-intervention

时间窗: 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.

次要结局

  • Change from Baseline in General Screening Knowledge Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Perceived Disease Risk Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Values Clarity Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Perceived Disease Severity Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Decisional Balance Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1))
  • Change from Baseline in General Screening Attitudes Immediately Post-Intervention(Pre and Post Intervention (same visit - Day 1)))

研究者

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

Stacey Sheridan, MD

Associate Professor of Medicine

University of North Carolina, Chapel Hill

研究点 (1)

Loading locations...

相似试验