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.

Study Overview

• Status: Completed
• Conditions: Healthy Men Age 50 Who Are Considering PSA Screening
• Intervention / Treatment: Behavioral: DESI for home viewing; Behavioral: DESI for viewing at Shared Medical Appointment; Behavioral: Option of SMA and DESI or DESI only

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.

• Study Type: Interventional
• Enrollment (Actual): 2521
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA test vs. No PSA test	We will determine whether a DESI viewing had an impact on testing.	12 month follow-up
Healthcare utilization and costs	All prostate specific health care utilization and cost will be estimate for each group.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DESI viewing	Did the patient view the decision support intervention or not?	4 months after mailings
Decision specific knowledge	Patient's knowledge will be assessed with a validated 10-item measure.	4 months after mailings
Discussion with provider	Patients will be asked if they discussed prostate cancer screening with a healthcare provider.	4 months after mailings

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Palo Alto Medical Foundation

Publications and helpful links

General Publications

• Lewis CL, Adams J, Tai-Seale M, Huang Q, Knowles SB, Nielsen ME, Pignone MP, Walter LC, Frosch DL. A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings. J Gen Intern Med. 2015 Jun;30(6):810-6. doi: 10.1007/s11606-015-3214-9. Epub 2015 Feb 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: November 15, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (ESTIMATE): November 16, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Prostate cancer; Decision support intervention (DESI); Shared medical appointments (SMA); Comparative effectiveness research (CER)
• Other Study ID Numbers: 10-1317; 1R18AE000023-01 (U.S. NIH Grant/Contract)