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

Not Applicable

Completed

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

• Registration Number: NCT01241656
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2521

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

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Exclusion Criteria

• Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invite to SMA to view and discuss DESI	DESI for viewing at Shared Medical Appointment	-
Mail DVD	DESI for home viewing	-
SMA and DVD	Option of SMA and DESI or DESI only	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Palo Alto Medical Foundation Research Institute; 🇺🇸 Palo Alto, California, United States

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States