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IMPACT - Integrative Medicine PrimAry Care Trial

University of Arizona logo

University of Arizona

Status

Unknown

Conditions

Adult Primary Care Patients

Treatments

Other: Integrative medicine primary care model

Study type

Observational

Funder types

Other

Identifiers

NCT01785485
Coors001

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Outcomes Study Sample:

Inclusion Criteria:

  • Enrollment in primary care (members) at UAIHC;
  • Adults age 18 or older.

Exclusion Criteria:

  • Currently pregnant at time of recruitment;
  • Patients who attend the UAIHC clinic as consultation-only patients;
  • Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.

Fidelity Study Sample (Patients):

Inclusion Criteria:

  • Enrollment in primary care (members) at UAIHC;
  • Adults age 18 or older.

Exclusion Criteria:

  • Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.

Fidelity Study Sample (Providers):

Inclusion Criteria:

  • All clinical and support personnel.

Exclusion Criteria:

  • None.

Trial design

500 participants in 1 patient group

Primary care patients
Description:
Primary care patients who are members of UAIHC.
Treatment:
Other: Integrative medicine primary care model

Trial contacts and locations

1

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Central trial contact

Sally E Dodds; TBA

Data sourced from clinicaltrials.gov

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