Understanding and Discouraging Overuse of Potentially Harmful Screening Tests

University of North Carolina (UNC)

Status: Completed

Conditions: Osteoporosis; Preventive Screening; Prostate Cancer; Colorectal Cancer

Treatments: Behavioral: Narrative Information Sheet; Behavioral: Quantitative Information Sheet; Behavioral: Framed Information Sheet; Behavioral: Qualitative Information Sheet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01694784

12-1338

Details and patient eligibility

About

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).

Enrollment: 775 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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775 participants in 4 patient groups

Quantitative

Experimental group

Description:

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.

Treatment:

Behavioral: Quantitative Information Sheet

Qualitative

Active Comparator group

Description:

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

Treatment:

Behavioral: Qualitative Information Sheet

Narrative

Experimental group

Description:

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.

Treatment:

Behavioral: Narrative Information Sheet

Framed

Experimental group

Description:

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.

Treatment:

Behavioral: Framed Information Sheet