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IMPACT - Integrative Medicine PrimAry Care Trial

NCT01785485 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2013-02-07

No results posted yet for this study

Summary

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.

Conditions

  • Adult Primary Care Patients

Interventions

OTHER

Integrative medicine primary care model

An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Victoria Maizes, MD · University of Arizona Arizona Center for Integrative Medicine

  • Sally E Dodds, PhD · University of Arizona Arizona Center for Integrative Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01785485 on ClinicalTrials.gov