Clinical trials are critical for medical decision making, however, under the current paradigm, clinical trials are fraught with problems, including low enrollment of eligible patients, poor study compliance and high cost for the specialized infrastructure for study conduct. Most trials are of an explanatory nature (i.e., efficacy under ideal, highly controlled conditions) rather than pragmatic (evidence of effectiveness in a real clinical situation). Comparative effectiveness methods (CEM) seek to reduce the inefficiency and high cost of clinical trials while comparing effective interventions in a real world setting wih decisions tailored to individual patient needs. CEM strategies, such as electronic initiatives, the use of centralized databases with remote data capture (RDC), and integration of the electronic medical record (EMR) with RDC for trial data collection, patient enrollment, and data management, are revolutionizing the conduct of clinical trials through cost reduction and improved efficiency. The objective of this proposal is 1) to implement a seamless clinical trial lifecycle using EMR initiatives and 2) to design and conduct a Phase II trial using EMR-RDC integration to evaluate an asthma management program for urban teens in a clinical setting. Urban clinics from Henry Ford Health System of Detroit and Kaiser Permanente of Atlanta will participate. Both are members of the HMO Research Network (HMORN) which has developed an innovative Virtual Data Warehouse (VDW) for common EMR data collection.
The specific aims of this proposal are:
Aim 1 Design a Phase II pragmatic cluster randomized trial of a web-based asthma management intervention in teens with asthma attending urban clinics, using adaptive approaches to plan a future Phase III trial.
Aim 2 : Use electronic initiatives for patient enrollment and management including EMR back-end and front-end for patient recruitment, online consent, and electronic monitoring of intervention compliance and follow-up.
Aim 3 : Establish and maintain a centralized Oracle Clinical infrastructure with RDC integration to EMR/VDW and electronic patient reported outcomes (ePROs). Our pragmatic approach with electronic initiatives will (a) minimize the need for new infrastructure for trial conduct;(b) maximize electronic retrieval of clinical endpoints (thereby minimizing the need for non-routine care clinic visits);(c) allow exploration of web-based patient assent/consent;(d) allow electroni monitoring of compliance to study regimen, and (e) maximize external validity. We will randomize 9 clinics with 250 teens for this Phase II trial (pilot study) to test feasibility, validty and cost of the trial. Using elements of the adaptive design for clinical trials, we will assess futility and feasibility of the proposed intervention. If no futility is observed, we will seek funing for a Phase III trial with more HMORN sites and a larger study population.
Our multidisciplinary team, with extensive experience in clinical trial design, will conduct a pragmatic cluster randomized trial with an adaptive design. This PCRT will use state- of-art centralized infrastructure, including the integration of an EMR and EMR-RDC database, to evaluate a behavioral intervention in the outpatient clinic setting. This approach will significantly increase study recruitment and reduce study-associated costs.
| Joseph, Christine Lm; Ownby, Dennis R; Zoratti, Edward et al. (2016) Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure. Clin Res Regul Aff 33:25-32 |
| Bassirpour, Gillian; Zoratti, Edward (2014) Cockroach allergy and allergen-specific immunotherapy in asthma: potential and pitfalls. Curr Opin Allergy Clin Immunol 14:535-41 |
| Lu, Mei; Ownby, Dennis R; Zoratti, Edward et al. (2014) Improving efficiency and reducing costs: Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program. Contemp Clin Trials 38:19-27 |
| Joseph, Christine L M; Ownby, Dennis R; Havstad, Suzanne L et al. (2013) Evaluation of a web-based asthma management intervention program for urban teenagers: reaching the hard to reach. J Adolesc Health 52:419-26 |
