Method: This is a 2-armed randomized controlled trial (target: 300 patients per arm). Intervention Arm features DATES Web, the interactive DA that elicits patient risk for CRC and clarifies preference for a specific CRC screening test option. Control Arm features a web-based DA with the same information but without the interactive features. Setting is 10 community and 1 university-based primary care practices in Metro Detroit. Participants are adults aged 50 to 75 years, not current on CRC screening, and scheduled for a regular visit with their physicians. In the clinic before the patient-physician encounter, participants complete a Patient Baseline Survey before being randomized. Data are collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording) and after it (Post-Encounter Survey). A 6-month chart audit is performed to determine whether the patient underwent CRC screening. Primary outcomes are: patient uptake of CRC screening, patient decision quality (knowledge, preference clarification, intent), degree of shared decision making, and patient-physician agreement regarding test preference. Independent samples t-tests and Pearson's Chi-squared tests were used to compare the baseline demographic and web usage data between the arms.
Result: So far, 258 participants have been recruited. Mean age + standard deviation 58.9 (6.9) years; racial distribution 44.1% Caucasian and 48.0% African American; gender distribution 52.5% women and 47.5% men, difference between the 2 arms statistically not significant (NS). Differences in knowledge, attitude, perceived self-efficacy, decision-making preference, and test preference at baseline are statistically NS between the 2 arms. Average duration of website usage is 23.9 minutes in the Control Arm vs. 25.6 minutes in the Intervention Arm (NS).
Conclusion: The recruitment and randomization process have been successful. The results of our study will be among the first to examine the effect of a real-time preference assessment exercise on CRC screening and mediators, and, in doing so, will shed light on the patient-physician communication and shared decision making "black box" that currently exists between the delivery of DAs to patients and the subsequent patient behavior.