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.

BACKGROUND: Integrative 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/DESIGN: This 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. DISCUSSION: The 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 REGISTRATION: Clinical Trials.gov NCT01785485.

When a whole practice model is the intervention: developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic.

Integrative medicine (IM) is a clinical paradigm of whole person healthcare that combines appropriate conventional and complementary medicine (CM) treatments. Studies of integrative healthcare systems and theory-driven evaluations of IM practice models need to be undertaken. Two health services research methods can strengthen the validity of IM healthcare studies, practice theory, and fidelity evaluation. The University of Arizona Integrative Health Center (UAIHC) is a membership-supported integrative primary care clinic in Phoenix, AZ. A comparative effectiveness evaluation is being conducted to assess its clinical and cost outcomes. A process evaluation of the clinic's practice theory components assesses model fidelity for four purposes: (1) as a measure of intervention integrity to determine whether the practice model was delivered as intended; (2) to describe an integrative primary care clinic model as it is being developed and refined; (3) as potential covariates in the outcomes analyses, to assist in interpretation of findings, and for external validity and replication; and (4) to provide feedback for needed corrections and improvements of clinic operations over time. This paper provides a rationale for the use of practice theory and fidelity evaluation in studies of integrative practices and describes the approach and protocol used in fidelity evaluation of the UAIHC.