IMPACT - Integrative Medicine PrimAry Care Trial

Study Overview
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Brief Summary
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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.

Official Title
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IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic

Conditions
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Adult Primary Care Patients

Intervention / Treatment
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* Other: Integrative medicine primary care model


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary care patients<br>Primary care patients who are members of UAIHC. | Other: Integrative medicine primary care model<br>* An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total healthcare costs from the payer's perspective-total paid costs according to claims data. |  | 12 months of paid costs pre and post beginning membership at UAIHC | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Self-report instruments | Composite: Short Form -12 (Ware, 1996) WHO-5 Well-being Index (Bech, 2003) Perceived Stress Scale (Cohen 1983). Work Productivity and Activity Impairment (Reilly, 1993). Patient Activation Measure (Hibbard, 2004). Diet quality. Behavioral Risk Factor Surveillance System Fruits/Vegetables (CDC, 2012). Physical Activity. Behavioral Risk Factor Surveillance System Physical Activity (CDC, 2012). Stress burden (Littman, 2006). Depression. PHQ-2 (Kroenke, 2003). Anxiety Disorder. GAD-2 (Kroenke, 2007). Pittsburgh Sleep Quality Index (Buysse, 1989). Fatigue visual analogue scale. Fatigue Severity Scale (Krupp, 1989). Pain visual analogue scale. If diagnosed: Fibromyalgia Impact Questionnaire-R (Williams & Arnold, 2011); Roland-Morris Disability Questionnaire (Roland & Morris, 1983); PHQ 9 (Kroenke et al 2002); GAD 7 (Spitzer et al, 2006). Demographics (Baseline). Expectations for care (Baseline). Patient satisfaction. 2-items from the CAHPS (AHRQ, 2012). | Baseline, 3-, 6-, and 12-months | 
| Clinical indicators and biomarkers | Composite: Complete metabolic panel, hypoglycemic medication, full lipid panel (TC, HDL, fasting triglycerides), lipid medication, TSH/T4, HbA1c, systolic and diastolic blood pressure, hypertension medication, BMI (height & weight), waist circumference, body fat composition, smoking status, cardiovascular disease risk (general and events), metabolic syndrome diagnosis. | 3-, 6-, and 12-months | 
| Service Utilization Data and Health Insurance Claims Data |  | 3-, 6-, and 12-months; biennially | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Integrative medicine, primary care, cost-effectiveness