Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. These disparities are especially true in urban teens.
We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City). Results showed reductions in self report of symptoms and activity limitations. Puff City has not yet been evaluated as a clinical tool or one that is initiated in a clinical setting. The current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management.
Electronic initiatives such as remote data capture (RDC) for data collection and utilization of patient electronic medical records (EMR) are revolutionizing the conduct of clinical trials. Comparative effectiveness methods (CEMs), adaptive designs and pragmatic trials, are recommended to enhance trial efficiency and to study real-world effectiveness.
The objective of this project is 1) to implement a seamless clinical trial lifecycle through electronic initiatives and ii) to design and conduct a phase II/III randomization trial using both CEMs and EMR-RDC integration to evaluate Puff City in teens in a clinical setting.
Aim 1: Design an adaptive seamless phase II/III PCRT of the Puff City Intervention in urban teens at clinics with a history of asthma.
Aim 2: Develop and maintain procedure(s) for patient recruitment and retention based on EMRs or other electronic initiatives including consent, randomization, and retention/follow-up. A focus group study and clinic facilitator training will be performed before conducting the efficiency trial.
Aim 3: Establish and maintain a robust, standardized Oracle Clinical (OC) infrastructure with remote data capture (RDC) ability for case report form (CRF) data collection with high integration to EMR or electronic patient reported (ePRO) data. A reliability study will be conducted to test the accuracy and adaptability of the EMRs.
250 teens with a history of asthma seen at the Henry Ford Health System in Detroit and Kaiser Permanente of Atlanta, GA.