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Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1


N/A
50 Years
75 Years
Not Enrolling
Male
Healthy Men Age 50 Who Are Considering PSA Screening

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Trial Information

Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1


We will use a randomized experimental design to compare the effects of 3 different
strategies to implement a prostate cancer screening decision support intervention (DESI)
with a control condition in primary care in 2 clinical systems - PAMF (Palo Alto Medical
Foundation) and UNC. The primary outcomes of interest are men's screening decisions and
their subsequent healthcare utilization. Secondary outcomes include the likelihood that
they review the DESI and their decision-specific knowledge. The 3 strategies selected by the
PAMF and UNC health systems are: (1) mailing men a DESI in DVD; (2) inviting men to
participate in a shared (group) medical appointment (SMA) to watch and discuss the DESI with
a healthcare provider and other men; and (3) providing men options by inviting them to a SMA
while also providing them a DESI in DVD which they can use individually if they are unable
or choose not to attend a SMA. The 3 groups will be compared to a control condition that
does not receive a DESI but will be encouraged to discuss prostate cancer screening with
their physician. Because of its significantly larger patient population, the PAMF site will
also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday,
when they first become guideline eligible to consider prostate cancer screening.


Inclusion Criteria:



- age 50 or older

- do not have a prostate diagnosis

- have not had a PSA test in the past 10 months

- have not seen their primary care physicians in the last 3 months

Exclusion Criteria:

- Women

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:

PSA test vs. No PSA test

Outcome Description:

We will determine whether a DESI viewing had an impact on testing.

Outcome Time Frame:

12 month follow-up

Safety Issue:

No

Principal Investigator

Carmen L Lewis, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill

Authority:

United States: Institutional Review Board

Study ID:

10-1317

NCT ID:

NCT01241656

Start Date:

January 2011

Completion Date:

December 2012

Related Keywords:

  • Healthy Men Age 50 Who Are Considering PSA Screening
  • Prostate cancer
  • Decision support intervention (DESI)
  • Shared medical appointments (SMA)
  • Comparative effectiveness research (CER)
  • Prostatic Neoplasms

Name

Location
University of North Carolina, Chapel Hill Chapel Hill, North Carolina  27599
Palo Alto Medical Foundation Research Institute Palo Alto, California  94301