IMPACT - Integrative Medicine PrimAry Care Trial
- Conditions
- Adult Primary Care Patients
- Interventions
- Other: Integrative medicine primary care model
- Registration Number
- NCT01785485
- Lead Sponsor
- University of Arizona
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- Enrollment in primary care (members) at UAIHC;
- Adults age 18 or older.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Primary care patients Integrative medicine primary care model Primary care patients who are members of UAIHC.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 1. Self-report instruments Baseline, 3-, 6-, and 12-months 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).Clinical indicators and biomarkers 3-, 6-, and 12-months 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.Service Utilization Data and Health Insurance Claims Data 3-, 6-, and 12-months; biennially
Trial Locations
- Locations (1)
University of Arizona Integrative Health Center (UAIHC)
🇺🇸Phoenix, Arizona, United States