The overarching goal of PRIMIER is to build a national database that will enable PRIMIER researchers to evaluate the change in patient-reported outcomes (e.g., quality of life, mood, stress, and pain) over time for patients receiving integrative healthcare.
The database is populated as patients complete an online survey at specified intervals. Over time, it is expected that up to 10,000 patients at the 14 participating clinics will complete questionnaires at baseline and then every two months for six months, and then every six months thereafter for two years.
The online survey utilizes a secure electronic platform called REDCap, which is a research program developed at Vanderbilt University and widely used by thousands of investigators at medical schools across the nation for conducting healthcare research. The encrypted database allows each participating clinic to view its own patient survey data, while the Data Coordinating Center at Albert Einstein College of Medicine has access to the combined data from all of the 14 centers.
Every six months, the patient survey measures are integrated with data extracted from the corresponding electronic health records (EHR) at each center. The EHR data includes dates of clinical visits, procedure codes (CPT), and clinical diagnoses (ICD-9/ICD-10), and if available, weight, height and pain scores. This information is securely aggregated at the Data Coordinating Center where data analyses are performed.
PRIMIER is conducted in accordance with current International Conference on Harmonisation guidelines on Good Clinical Practice (ICH E6, the principles of which have their origin in the Declaration of Helsinki), and all other applicable national and local laws and regulations. Institutional Review Boards at each PBRN site and the coordinating center have reviewed and approved the protocol and subsequent amendments.
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