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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
  Purpose

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.


Condition Intervention
Healthy Men Age 50 Who Are Considering PSA Screening
Behavioral: DESI for home viewing
Behavioral: DESI for viewing at Shared Medical Appointment
Behavioral: Option of SMA and DESI or DESI only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2521
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mail DVD 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.
Experimental: Invite to SMA to view and discuss DESI 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.
Experimental: SMA and DVD 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.
No Intervention: Encouraged to talk to physician

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241656

Locations
United States, California
Palo Alto Medical Foundation Research Institute
Palo Alto, California, United States, 94301
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Palo Alto Medical Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: Carmen Lewis, MD, MPH, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01241656     History of Changes
Other Study ID Numbers: 10-1317, 1R18AE000023 - 01
Study First Received: November 15, 2010
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
Prostate cancer
Decision support intervention (DESI)
Shared medical appointments (SMA)
Comparative effectiveness research (CER)

ClinicalTrials.gov processed this record on November 20, 2014