IMPACT - Integrative Medicine PrimAry Care Trial

Status unconfirmed

Conditions studied: Adult Primary Care Patients

In brief

This study is Phase II of a project by the University of Arizona Center for Integrative Medicine (AzCIM). Collaborating with AzCIM is the Health Outcomes and Pharmacoeconomics (HOPE) Center and the RAND Corporation, Inc. Phase II is a prospective evaluation of the clinical and cost effectiveness (outcomes) of an integrative medicine professional practice model for adult primary care delivery (the University of Arizona Integrative Health Center - UAIHC in Phoenix, AZ). Data will be gathered from eligible and consenting members of UAIHC. In addition, a fidelity evaluation will assess whether the practice model was implemented as planned. The specific aims are to: 1) Recruit, consent, and enroll a sample of eligible patient and staff participants from UAIHC; 2) Conduct outcome evaluation of UAIHC care using patient data from medical records abstractions, self-report assessments, clinic administrative and service utilization/encounter data, and health insurance claims data; and, 3) Conduct fidelity evaluation of the implementation of the UAIHC model as described in its business plan using patient- and staff-reported fidelity assessments, random chart audits, and abstracted clinic administrative data. Participants. 1) Participants from the clinic patient population for whom clinical and cost outcomes will be tracked (n=500); 2) Clinic patients from whom fidelity data will be collected (n=180); and, 3) Clinic personnel from whom fidelity data will also be collected (n=14). Data Collection. For outcomes evaluation, data will be collected at baseline (initial clinic visit), and at 3-, 6-, and 12-month follow up periods. Sources include clinical symptoms and biomarkers from medical records abstractions; patient reported outcomes and satisfaction questionnaires; clinic service encounter logs; and, cost data from health insurance claims information and clinic financial data. For fidelity evaluation, data will be collected monthly for 6 months after study start, quarterly for the next 6 months, and semi-annually from then on. Patient data for fidelity will be gathered on a single randomized day of the week using a self-administered patient feedback questionnaire. For personnel, fidelity data will be collected at the same intervals using a self-administered provider perceptions questionnaire of inter-professional team and integrative medical care. Data from audits of randomly selected patient charts and administrative records will also be used.

Key facts

Study ID
NCT01785485
Run by
University of Arizona
People needed
500
Starts
2013-02-01
Expected to finish
2015-10-01
Last updated by the study team
2013-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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