Completed

Understanding and Discouraging Overuse of Potentially Harmful Screening Tests

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What is being tested

Quantitative Information Sheet

+ Qualitative Information Sheet

+ Narrative Information Sheet

Behavioral
Who is being recruted

Urogenital Diseases+22

+ Genital Diseases

+ Bone Diseases

From 50 to 85 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: April 19, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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).

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: April 19, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

775 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 50 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBone DiseasesBone Diseases, MetabolicColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsGenital Diseases, MaleGenital Neoplasms, MaleIntestinal DiseasesIntestinal NeoplasmsMetabolic DiseasesMusculoskeletal DiseasesNeoplasmsNeoplasms by SiteNutritional and Metabolic DiseasesProstatic DiseasesRectal DiseasesUrogenital NeoplasmsMale Urogenital DiseasesOsteoporosisProstatic NeoplasmsColorectal Neoplasms

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

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.

Group IV

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Duke Primary Care Research Consortium

Durham, United StatesOpen Duke Primary Care Research Consortium in Google Maps
CompletedOne Study Center