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Understanding and Discouraging Overuse of Potentially Harmful Screening Tests


N/A
50 Years
85 Years
Open (Enrolling by invite only)
Both
Preventive Screening, Prostate Cancer, Osteoporosis, Colorectal Cancer

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Trial Information

Understanding and Discouraging Overuse of Potentially Harmful Screening Tests


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Change from Baseline in Intent to Accept Screening Immediately Post-intervention

Outcome Description:

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.

Outcome Time Frame:

Pre and Post Intervention (same visit - Day 1)

Safety Issue:

No

Principal Investigator

Stacey Sheridan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Federal Government

Study ID:

12-1338

NCT ID:

NCT01694784

Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Preventive Screening
  • Prostate Cancer
  • Osteoporosis
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location
Duke Primary Care Research Consortium Durham, North Carolina  27704