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Randomized Controlled Trial
. 2013 Jun;91(3):329-36.
doi: 10.1016/j.pec.2012.12.013. Epub 2013 Jan 26.

Fostering informed decisions: a randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer

Randi M Williams  1 , Kimberly M Davis, George Luta, Sara N Edmond, Caroline S Dorfman, Marc D Schwartz, John Lynch, Chiledum Ahaghotu, Kathryn L Taylor
Affiliations
Randomized Controlled Trial

Fostering informed decisions: a randomized controlled trial assessing the impact of a decision aid among men registered to undergo mass screening for prostate cancer

Randi M Williams et al. Patient Educ Couns. 2013 Jun.

Abstract

Objective: Screening asymptomatic men for prostate cancer is controversial and informed decision making is recommended. Within two prostate cancer screening programs, we evaluated the impact of a print-based decision aid (DA) on decision-making outcomes.

Methods: Men (N=543) were 54.9 (SD=8.1) years old and 61% were African-American. The 2(booklet type: DA vs. usual care (UC))× 2(delivery mode: Home vs. Clinic) randomized controlled trial assessed decisional and screening outcomes at baseline, 2-months, and 13-months.

Results: Intention-to-treat linear regression analyses using generalized estimating equations revealed that DA participants reported improved knowledge relative to UC (B=.41, p<.05). For decisional conflict, per-protocol analyses revealed a group by time interaction (B=-.69, p<.05), indicating that DA participants were less likely to report decisional conflict at 2-months compared to UC participants (OR=.49, 95% CI: .26-.91, p<.05).

Conclusion: This is the first randomized trial to evaluate a DA in the context of free mass screening, a challenging setting in which to make an informed decision. The DA was highly utilized by participants, improved knowledge and reduced decisional conflict.

Practice implications: These results are valuable in understanding ways to improve the decisions of men who seek screening and can be easily implemented within many settings.

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Conflict of interest statement

Conflicts of Interest: None of the authors have any conflicts of interest or financial disclosures to report.

Figures

Figure 1
Figure 1
Study Procedure and Retention Rates Note. CNR: Could not Reach; GUMC: Georgetown University Medical Center; HUCC: Howard University Cancer Center; DA: Decision Aid; UC: Usual Care.
Figure 2
Figure 2
Knowledge Stratified by Booklet Type Intent-to-treat analyses (N = 381)
Figure 3
Figure 3
Decisional Conflict Stratified by Booklet Type Per-protocol analyses (N = 289)
See this image and copyright information in PMC

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