A Randomized Controlled Effectiveness Trial for PSA Screening Decision Support Interventions in Two Primary Care Settings

Abstract

Background: Decision support interventions (DESIs) provide a mechanism to translate comparative effectiveness research results into clinical care so that patients are able to make informed decisions. Patient decision support interventions for prostate-specific antigen (PSA) have been shown to promote informed decision making and reduce PSA testing in efficacy trials, but their impact in real world settings is not clear.

Objective: We performed an effectiveness trial of PSA decision support interventions in primary care.

Design: A randomized controlled trial of three distribution strategies was compared to a control.

Participants: Participants included 2,550 men eligible for PSA testing (76.6 % of the eligible population) and 2001 survey respondents (60.1 % survey response rate).

Interventions: The intervention groups were: 1) mailed the DESI in DVD format, 2) offered a shared medical appointment (SMA) to view the DESI with other men and discuss, and 3) both options.

Main measures: We measured PSA testing identified via electronic medical record at 12 months and DESI use by self-report 4 months after the intervention mailing.

Key results: We found no differences in PSA testing across the three distribution strategies over a year-long follow-up period: 21 %, 24 %, 22 % in the DESI, SMA, and combined group respectively, compared to 21 % in the control group (p = 0.51). Self-reported DESI use was low across all strategies at 4 months: 16 % in the mailed DESI group, 6 % in the SMA group, and 15 % in the combined group (p = < 0.0001).

Conclusions: Mailing PSA decision support interventions or inviting men to shared medical appointments unrelated to a primary care office visit do not appear to promote informed decision making, or change PSA testing behavior.

Trial registration: ClinicalTrials.gov NCT01241656.

Figures

Figure 1

Randomization, eligibility, and participation