Clinical trial NCT01694784: Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
Official title: Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Screening
Prostate Cancer
Osteoporosis
Colorectal Cancer
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Duke University
First posted: 2012-09-27
Enrollment: 775
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Change from Baseline in Intent to Accept Screening Immediately Post-intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
Secondary outcomes:
measure: Change from Baseline in Perceived Disease Risk Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in Perceived Disease Severity Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in Decisional Balance Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in Values Clarity Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in General Screening Knowledge Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1)
measure: Change from Baseline in General Screening Attitudes Immediately Post-Intervention
timeFrame: Pre and Post Intervention (same visit - Day 1))
Other outcomes:
measure: Key moderating variables
timeFrame: pre-intervention
Locations:
city: Durham
country: United States
facility: Duke Primary Care Research Consortium
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Stacey Sheridan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sheridan SL, Sutkowi-Hemstreet A, Barclay C, Brewer NT, Dolor RJ, Gizlice Z, Lewis CL, Reuland DS, Golin CE, Kistler CE, Vu M, Harris R. A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jan;176(1):31-41. doi: 10.1001/jamainternmed.2015.7339.