- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01694784
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
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).
Přehled studie
Postavení
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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North Carolina
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Durham, North Carolina, Spojené státy, 27704
- Duke Primary Care Research Consortium
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Quantitative
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.
|
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.
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Aktivní komparátor: Qualitative
In the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet.
|
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.
|
Experimentální: Narrative
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.
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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.
|
Experimentální: Framed
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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from Baseline in Intent to Accept Screening Immediately Post-intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
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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.
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Pre and Post Intervention (same visit - Day 1)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change from Baseline in Perceived Disease Risk Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
|
Perceived risk or susceptibility of disease will be measured for each disease state under study using one item that reads, "How likely is that you will get (insert prostate cancer, osteoporosis, or colon cancer) in the next 10 years?"
Answers will be on a likert scale from "not at all likely" to "very likely."
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Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in Perceived Disease Severity Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
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Perceived Disease Severity will be measured for each disease state under study using the Revised Illness Perceptions Questionnaire for Healthy People.
It includes the following four questions: 1) x (insert prostate cancer, osteoporosis, or colon cancer) has serious financial consequences; 2) x strongly affects the way the patient sees himself as a person; 3) x causes difficulties to those close to the patient; 4) x is very serious.
Answers will be on a 5-point scale from "strongly disagree" to "strongly agree."
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Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
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Two questions central to understanding each exemplar service (i.e. prostate cancer screening, osteoporosis screening, colon cancer screening) were selected to assess specific knowledge. Response options include true, false, or don't know. Questions for prostate cancer screening are:
Questions for colon cancer screening are:
Questions for Osteoporosis screening are:
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Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
|
Six questions will assess participants' attitudes about each screening service under study. Questions include:
Response options range from "strongly disagree" to "strongly agree". |
Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in Decisional Balance Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
|
Decisional balance will be measured by a single item for each screening service under study.
Participants will be asked, "Which best describes how you feel right now?" Participants will select one of the following answers: 1) The benefits of X (insert prostate cancer, colon cancer, osteoporosis) screening greatly outweigh the harms; 2) The benefits of X screening somewhat outweigh the harms; 3) The benefits and harms of X screening are about the same; 4) The harms of X screening somewhat outweigh the benefits; and 5) The harms of X screening greatly outweigh the benefits.
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Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in Values Clarity Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
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Values Clarity will be measured with three items for the values subscale of the decisional conflict scale. Items include:
Response options range from strongly disagree to strongly agree. |
Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in General Screening Knowledge Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1)
|
General screening knowledge will be assessed using 8 items developed by investigators. Questions include:
Response options are true, false, or don't know. |
Pre and Post Intervention (same visit - Day 1)
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Change from Baseline in General Screening Attitudes Immediately Post-Intervention
Časové okno: Pre and Post Intervention (same visit - Day 1))
|
General Screening Attitudes will be assessed at baseline by 38 questions that were developed by investigators and assessed for content validity by panel of experts. Questions assess the following sub-constructs: General approach to screening, Value of Screening, Need to Know about Disease, Early Detection/Treatment, Benefits, Harms, Anticipated Regret in Choosing for/against screening, Duty/Responsibility to be screened, Effect on screening on MD/patient relationship. Response options range from "strongly disagree" to "strongly agree" on a 5-point scale. At post intervention, a subset of 12 of the 38 questions (1-2 from each subconstruct) will be used to assess changes in general screening attitudes. |
Pre and Post Intervention (same visit - Day 1))
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Key moderating variables
Časové okno: pre-intervention
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Multiple variables will be measured to examine whether they moderate the effect of the intervention on the primary outcome intent for screening. These variables include:
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pre-intervention
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Stacey Sheridan, MD, University of North Carolina, Chapel Hill
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 12-1338
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