Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
Quantitative Information Sheet
+ Qualitative Information Sheet
+ Narrative Information Sheet
Urogenital Diseases+22
+ Genital Diseases
+ Bone Diseases
Prevention Study
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.775 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorGroup III
ExperimentalGroup IV
ExperimentalStudy 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