IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model

BMC Complementary and Alternative Medicine

Study Protocol

Robert L Crocker¹  Randy Horwitz¹  Sally E Dodds¹  Victoria H Maizes¹  Ivo Abraham²  Rick A Rehfeld²  Amy J Grizzle²  Terry F Urbine²  Patricia M Herman³  Melanie D Logue⁴ 

[1] Arizona Center for Integrative Medicine, University of Arizona College of Medicine, Tucson, AZ, USA;Center for Health Outcomes & PharmacoEconomic Research (HOPE), University of Arizona College of Pharmacy, Tucson, AZ, USA;Health Unit, the RAND Corporation, Santa Monica, CA, USA;University of Arizona College of Nursing, Tucson, AZ, USA;Center for Health Outcomes & PharmacoEconomic Research (HOPE), University of Arizona College of Pharmacy, Tucson, AZ, USA;

关键词: Integrative medicine;    Observational study;    Study protocol;    Fidelity monitoring;    Implementation fidelity;    Complex interventions;    Comparative effectiveness research;    Healthcare utilization;    Cost outcomes;    Health services research;   

DOI  :  10.1186/1472-6882-14-132

 received in 2013-08-05, accepted in 2014-03-31,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundIntegrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM.Methods/DesignThis study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works.DiscussionThe US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential.Trial registrationClinical Trials.gov NCT01785485.

【 授权许可】

Unknown   
© Herman et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.