Table 2. Fidelity of study design strategies and monitoring plan for 24-START.
| Goal | Description from NIH BCC | Strategies used in 24-START | Fidelity monitoring plan for 24-START |
|---|---|---|---|
| Ensure intervention is congruent with relevant theory and practice | Operationalize treatment to optimally reflect theoretical roots; precisely define variables most relevant to “active ingredients” of the intervention | Coaches use Motivational Interviewing techniques in all calls | Monthly review of coaching call checklist† |
| Quarterly review of random selection of calls | |||
| Coaches use evidence-based behavior change strategies during calls and messages | Monthly review of coaching call checklists and messages | ||
| Integration of behavior change strategies into website | Initial review of website prior to beginning enrollment; quarterly audit of resources within resource bank | ||
| Ensure equal treatment dose within and across conditions | Ensure equal treatment “dose” (measured by number, frequency, and length of contact) is adequately described and is the same for each subject within a particular treatment condition | Standard call schedule for all participants: | Monthly audit of coaching call logs‡ |
| □ Weeks 1–12: weekly calls | |||
| □ Weeks 13–24: bi-weekly calls | |||
| Standard messaging schedule for all participants: | Monthly audit of messages posted to website | ||
| □ Weeks 1–12: one message/week | |||
| □ Weeks 13–24: one message/week in weeks with a phone call | |||
| □ Two messages/week in weeks with no call | |||
| Equivalent resources for both treatment groups | Quarterly audit of resource bank | ||
| Plan for implementation setbacks | Address possible setbacks in implementation (e.g., treatment providers dropping out) | Train multiple providers to ensure back up in the event of provider vacation, illness or turnover | NA |
†, coaching call checklists include standard methods for preparing for coaching calls, content areas to be covered in calls, and prompts for use of Motivational Interviewing; ‡, coaching call logs include time/date of scheduled call, if the call was successfully completed, and documentation of missed-call protocol. NIH BCC, NIH Behavior Change Consortium.