Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1

This study has been completed.
Sponsor:
Collaborators:
Palo Alto Medical Foundation
Information provided by (Responsible Party):
Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01241656
First received: November 15, 2010
Last updated: June 21, 2013
Last verified: June 2013

November 15, 2010
June 21, 2013
January 2011
December 2012   (final data collection date for primary outcome measure)
  • PSA test vs. No PSA test [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    We will determine whether a DESI viewing had an impact on testing.
  • Healthcare utilization and costs [ Time Frame: 12 month follow-up ] [ Designated as safety issue: No ]
    All prostate specific health care utilization and cost will be estimate for each group.
Same as current
Complete list of historical versions of study NCT01241656 on ClinicalTrials.gov Archive Site
  • DESI viewing [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]
    Did the patient view the decision support intervention or not?
  • Decision specific knowledge [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]
    Patient's knowledge will be assessed with a validated 10-item measure.
  • Discussion with provider [ Time Frame: 4 months after mailings ] [ Designated as safety issue: No ]
    Patients will be asked if they discussed prostate cancer screening with a healthcare provider.
Same as current
Not Provided
Not Provided
 
Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1

In this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (DESI) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design.

We hypothesize men who are given the opportunity to review a DESI by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Healthy Men Age 50 Who Are Considering PSA Screening
  • Behavioral: DESI for home viewing
    Decision support intervention is a 31 minute DVD mailed to the patients in all of the experimental groups. The program explains the function and location of the prostate and the nature of prostate cancer, including its associated mortality. Next, the program describes the different tests that are used to detect prostate cancer including the digital rectal exam, prostate specific antigen (PSA) test and prostate biopsy.
  • Behavioral: DESI for viewing at Shared Medical Appointment
    Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
  • Behavioral: Option of SMA and DESI or DESI only
    Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
  • Experimental: Mail DVD
    Intervention: Behavioral: DESI for home viewing
  • Experimental: Invite to SMA to view and discuss DESI
    Intervention: Behavioral: DESI for viewing at Shared Medical Appointment
  • Experimental: SMA and DVD
    Intervention: Behavioral: Option of SMA and DESI or DESI only
  • No Intervention: Encouraged to talk to physician
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2521
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Male
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01241656
10-1317, 1R18AE000023 - 01
No
Carmen Lewis, MD, MPH, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Palo Alto Medical Foundation
  • National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Carmen L Lewis, MD, MPH University of North Carolina, Chapel Hill
Principal Investigator: Ming Tai-Seale, Ph.D, MPH Palo Alto Medical Foundation
University of North Carolina, Chapel Hill
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP