Clinical trial NCT01785485: IMPACT - Integrative Medicine PrimAry Care Trial
Official title: IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adult Primary Care Patients
Keywords: Integrative medicine
primary care
cost-effectiveness
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only patients who are enrolled in primary care (members) at UAIHC and who meet the inclusion/exclusion criteria are eligible to enroll in this study

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Total healthcare costs from the payer's perspective-total paid costs according to claims data.
timeFrame: 12 months of paid costs pre and post beginning membership at UAIHC
Secondary outcomes:
measure: 1. Self-report instruments
timeFrame: Baseline, 3-, 6-, and 12-months
measure: Clinical indicators and biomarkers
timeFrame: 3-, 6-, and 12-months
measure: Service Utilization Data and Health Insurance Claims Data
timeFrame: 3-, 6-, and 12-months; biennially
Other outcomes:
measure: Patient Experiences (Fidelity)
timeFrame: Monthly for the first 6 mos., then each 3 months for the rest of the first year, then every 6 months.
measure: Provider Experiences (Fidelity)
timeFrame: Monthly for the first 6 months, then each 3 months for the rest of the first year, then every 6 months
measure: Medical records chart audit (Fidelity)
timeFrame: Monthly for the first 6 months, then each Monthly first 6 months then q. 3 months for the rest of the first year, then every 6 months
Locations:
city: Phoenix
country: United States
facility: University of Arizona Integrative Health Center (UAIHC)
state: Arizona
Study officials:
affiliation: University of Arizona Arizona Center for Integrative Medicine
name: Victoria Maizes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona Arizona Center for Integrative Medicine
name: Sally E Dodds, PhD
role: STUDY_DIRECTOR
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