This Phase I Small Business Innovation Research proposal is in response to RFA-AT- 09-004 Translational Tools for Clinical Studies of CAM Interventions. The proposed technology development and testing project integrates three important capabilities into one dynamic data collection and reporting system. The three components of this new system are (1) the ReliefInsite platform, a sophisticated and user-friendly secure HIPAA compliant web service, built on open-source technology, currently used for on-going patient assessment and longitudinal reporting for which new applications will be developed;(2) TEAMSI, a cutting edge documentation instrument for acupuncture charting to collect additional acupuncture-specific clinical information from patients and easily chart acupuncture treatments;and (3) incorporation of validated patient-reported outcome measures from the NIH Patient Reported Outcome Measurement Information System (PROMIS) and the RTI International CAM-PRO measures of patient-provider interaction, as well as demographics and provider information needed for research. The proposed system will provide a dynamic data collection tool that will facilitate both 1) the assessment of efficacy in randomized control trials of by operationalizing treatment protocols and 2) the study of clinical effectiveness in outcome studies by capturing what is going on in the """"""""real world"""""""" of clinical care. Key features of the new system include: incorporation of both patient and provider documentation in a single system;a means to assess patient adherence to treatments, medications, and self-care;the opportunity to evaluate dose responses to the intervention and track adverse events;and a means to provide standardized treatment algorithms and manualization approaches necessary to support more rigorous study designs. The application will incorporate information and measures useful across conditions and treatment approaches, while creating an acupuncture-specific application to advance acupuncture research and serve as a prototype for future CAM modality-specific designs.
Given widespread use of complementary and alternative medicine (CAM) such as acupuncture, there is a need for translational research tools to support studies of safety, efficacy and clinical effectiveness of treatment for various conditions. The proposed project will develop a state of the art, user-friendly data collection system to seamlessly integrate data collected from patients and clinicians in clinical and research settings.
