Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
1 other identifier
interventional
775
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 13, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 19, 2016
April 1, 2016
1.7 years
September 13, 2012
April 15, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Intent to Accept Screening Immediately Post-intervention
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.
Pre and Post Intervention (same visit - Day 1)
Secondary Outcomes (8)
Change from Baseline in Perceived Disease Risk 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 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 Decisional Balance Immediately Post-Intervention
Pre and Post Intervention (same visit - Day 1)
- +3 more secondary outcomes
Other Outcomes (1)
Key moderating variables
pre-intervention
Study Arms (4)
Quantitative
EXPERIMENTALIn 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.
Qualitative
ACTIVE COMPARATORIn the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet.
Narrative
EXPERIMENTALIn 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.
Framed
EXPERIMENTALIn 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.
Interventions
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the quantitative information sheet, harms will be communicated in absolute risks with accompanying fact box (i.e. box containing key facts and rates). In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and the screening test, a description of the possible benefits of the service, and a statement encouraging decision. As an adjunct to numerical information in paragraph form, fact boxes engage individuals to process information and improve understanding.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the qualitative information sheet, harms will be communicated using verbal descriptors. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the narrative information sheet, harms will be communicated using patient narratives with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the framed information sheet, harms will be communicated using a gain frame (as described in the arm section above) with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
Eligibility Criteria
You may qualify if:
- Women between ages 50 to 85
- Men between ages 50 to 85
You may not qualify if:
- 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)
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Agency for Healthcare Research and Quality (AHRQ)collaborator
- Duke Universitycollaborator
Study Sites (1)
Duke Primary Care Research Consortium
Durham, North Carolina, 27704, United States
Related Publications (1)
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.
PMID: 26720730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacey Sheridan, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
September 13, 2012
First Posted
September 27, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 19, 2016
Record last verified: 2016-04