Tailored System to Deliver Behavioral Intervention and Manage Data in Randomized Trials

Abstract

BackgroundThe integrity of behavioral intervention trials depends on consistent intervention delivery, and uniform, comprehensive process data collection. It can be challenging in practice due to complex human interactions involved. ObjectiveWe sought to design a system to support the fidelity of intervention delivery and efficient capture of qualitative and quantitative process data for a telephone-delivered behavioral counseling intervention to increase physical activity and function after total knee replacement surgery. MethodsA tailored system was designed to prompt the intervention coach in the delivery of a 5 step counseling protocol to support intervention fidelity across patients. System features included structured data components, automated data exchange functions, user-friendly data capture screens, and real-time surveillance reporting. The system structured the capture of patient goals and open-ended conversation. ResultsThe system recorded intervention process data from each of 12 sessions held with the 92 intervention patients. During the trial, 992 telephone sessions were conducted, and more than 97% (4816/4960) of intervention process data fields were completed in the system. The coach spent 5-10 minutes preparing for each counseling call using system-generated summaries of historical data and 10-15 minutes entering intervention process data following each telephone session. ConclusionsThis intervention delivery system successfully supported the delivery of a structured behavioral counseling intervention and collection of intervention process data. It addressed the unique needs of clinical behavioral intervention trials, and had promising potential to facilitate high-fidelity translation of the intervention to broad clinical practice and Web-based multicenter clinical trials in the future.