Clinical trial NCT01241656: Decision Support Interventions (DESI) for Prostate Cancer Screening - Study 1
Official title: Acceleration Adoption of Comparative Effectiveness Research Results With Patient Decision Support Intervention and Treatment (DESI)- Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men Age 50 Who Are Considering PSA Screening
Keywords: Prostate cancer
Decision support intervention (DESI)
Shared medical appointments (SMA)
Comparative effectiveness research (CER)
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Palo Alto Medical Foundation
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-11-16
Enrollment: 2521
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: PSA test vs. No PSA test
timeFrame: 12 month follow-up
measure: Healthcare utilization and costs
timeFrame: 12 month follow-up
Secondary outcomes:
measure: DESI viewing
timeFrame: 4 months after mailings
measure: Decision specific knowledge
timeFrame: 4 months after mailings
measure: Discussion with provider
timeFrame: 4 months after mailings
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carmen L Lewis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Palo Alto Medical Foundation
name: Ming Tai-Seale, Ph.D, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.