IMPORTANCE: The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions. OBJECTIVE: To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions. DESIGN, SETTING, AND PARTICIPANTS: A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures. INTERVENTION: Random assignment to print-based decision aid (n = 628), web-based interactive decision aid (n = 625), or usual care (UC) (n = 626). MAIN OUTCOMES AND MEASURES: Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening. RESULTS: Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d = 0.33) and print vs UC (d = 0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P = .009) and significantly more web (P = .001) and print (P = .03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P = .06) and web participants (50.4%; P = .10) were not significant. Screening rates at 13 months did not differ significantly among groups. CONCLUSIONS AND RELEVANCE: Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00196807.
RCT Entities:
IMPORTANCE: The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions. OBJECTIVE: To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions. DESIGN, SETTING, AND PARTICIPANTS: A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures. INTERVENTION: Random assignment to print-based decision aid (n = 628), web-based interactive decision aid (n = 625), or usual care (UC) (n = 626). MAIN OUTCOMES AND MEASURES: Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening. RESULTS: Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d = 0.33) and print vs UC (d = 0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P = .009) and significantly more web (P = .001) and print (P = .03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P = .06) and web participants (50.4%; P = .10) were not significant. Screening rates at 13 months did not differ significantly among groups. CONCLUSIONS AND RELEVANCE: Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00196807.
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