METHODS
RECRUITMENT, RECRUITMENT, SHOP
Recruitment and initial baseline assessment for the SMART-ED study took place between October 2010–February 2012 in six urban academic EDs in the US, each of which partnered with a node of the NIDA CTN (For this study our goal was to enroll 1,285 participants across sites over a nine-month period and complete follow-up visits at three, six, and 12 months post baseline.We used tablet computers for a number of project activities: 1) to screen and collect data; 2) access the electronic health record; and 3) collect participant contact information. In addition to eliminating the need for paper forms, tablet computers allowed study staff to receive immediate notification of participant eligibility and group randomization. Study staff approached potentially eligible patients after triage. The ED tracking boards helped to locate patients. Once they were enrolled, we collected participant contact information including 1) residential and mailing address, 2) phone number(s), 3) email address, 4) Social Security number, 5) place of employment, and 6) contact information for two “locators” (ie, persons who would know how to contact the participants during the course of the study). If they were not able to provide sufficient contact information, they were not eligible to participate (Compensation for completing the baseline and each follow-up assessment was $50 and $75, respectively. Baseline assessments took between 60–120 minutes, and follow-up assessments ranged between 90–210 minutes to complete. At a separate location from the ED, staff (who were blinded to treatment assignment) conducted follow-up assessments. Appointment cards, maps, and study contact information were provided at the initial ED baseline visit, and reminder calls were made prior to each follow-up visit.When a participant attended their follow-up study visit, staff were required to review and update all participant contact information. If a participant did not attend their follow-up visit, staff would, in order, do the following: attempt to reach the participant by varying times of call attempts; send email and text message; mail a letter to the participant; and contact the participant’s locators. If staff were unsuccessful in reaching the participant, they would conduct an internet search to try to obtain more current contact information. At one site, follow-up staff attempted to locate the participant in person at their home address. Across and within sites, there did not appear to be a single approach to locating participants and scheduling follow-ups that emerged as superior to another approach.Follow-up staff documented all contact attempts, regardless of success, in the “Contact Log,” which included date and time of attempted contact and a description and result of the attempt (Participant incarceration is an expected occurrence that poses challenges to completing follow-up. In anticipation of this reality, we obtained Office for Human Research Protections approval to conduct follow-up visits with participants who became incarcerated after enrollment, and the SMART-ED study sites pursued IRB approval. Ultimately, the ability of the study staff to follow up with the participant depended upon the study site’s IRB regulations, type of consent obtained from the participant, and the rules of the confining correctional facility.Another challenge to retention was the occasional participant request for withdrawal when contacted to schedule follow-up visit appointments. In such cases, we honored the request and mailed the participant a letter confirming their decision to withdraw, providing the study’s contact information, reviewing the benefits of participation, and inviting them to contact the study should they change their mind.Ongoing study staff training occurred throughout the study, emphasizing the importance of 1) recruitment study staff approaching all potentially eligible patients (post-triage) without regard to diagnosis, thus, improving the representativeness of the sample; and 2) follow-up study staff reviewing the methods for contacting participants. Additionally, weekly recruitment and retention calls with all sites provided a forum to discuss any recruitment and retention issues, clarify procedures, and troubleshoot unanticipated problems.Over the course of the study, we made several adjustments to improve participant retention. These adjustments included decreasing assessment time at follow-up (ie, fewer assessments administered at follow-up), expanding the time windows for completing assessments, and providing incentive compensation to study staff at sites who achieved an 85% follow-up rate or higher. The original four-week time window for completing follow-up assessment (two weeks before and two weeks after the ideal follow-up date) was opened to allow a participant six weeks to complete follow-up visit (two weeks prior and four weeks post the ideal follow-up date). For example, if someone’s follow-up was due on February 14, they could be seen as early as February 1 or as late as March 14 for their follow-up.This expanded follow-up time window offered participants increased flexibility and convenience when scheduling their visits without compromising follow-up data integrity. The incentive compensation offered to study staff who achieved 85% follow-up rates or higher was in the form of a $5 gift card to a coffee shop for each staff member involved in follow-ups at that site. This amount was felt to increase team motivation and promote friendly competition across the study sites to complete follow-up visits with participants, without encouraging coercive practices or dishonest reporting.