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

University of North Carolina (UNC)

Status: Completed

Conditions: Healthy Men Age 50 Who Are Considering PSA Screening

Treatments: Behavioral: Option of SMA and DESI or DESI only; Behavioral: DESI for home viewing; Behavioral: DESI for viewing at Shared Medical Appointment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01241656

10-1317

1R18AE000023-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,521 patients

Sex: Male

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,521 participants in 4 patient groups

Mail DVD

Experimental group

Treatment:

Behavioral: DESI for home viewing

Invite to SMA to view and discuss DESI

Experimental group

Treatment:

Behavioral: DESI for viewing at Shared Medical Appointment

SMA and DVD

Experimental group

Treatment:

Behavioral: Option of SMA and DESI or DESI only

Encouraged to talk to physician

No Intervention group