Adult Primary Care Patients Clinical Trial
Official title:
IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
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.
n/a
Observational Model: Case Control, Time Perspective: Prospective