Adult Primary Care Patients Clinical Trial
— IMPACTOfficial title:
IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic
| Verified date | February 2013 |
| Source | University of Arizona |
| Contact | TBA |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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: |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Arizona Integrative Health Center (UAIHC) | Phoenix | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| University of Arizona |
United States,
Agency for Healthcare Research and Quality. (2012). Consumer Assessment of Healthcare Providers and Systems surveys. Accessed October 12, 2012 from the World Wide Web ar http://cahps.ahrq.gov/clinician_group.
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Patient Experiences (Fidelity) | Composite: Dimensions assessed: access to care, whole person care, promotion of self-care and wellness, practitioner communication style, shared decision-making, trust in the practitioner, perceived practitioner empathy, perceived health partnership, and demographic information (CAHPS - AHRQ, 2012; ACES - Safran et al, 1998); CARE - Mercer, et al, 2004). |
Monthly for the first 6 mos., then each 3 months for the rest of the first year, then every 6 months. | No |
| Other | Provider Experiences (Fidelity) | Composite: Team Climate Inventory Short Version (TCI - Anderson & West, 1995; Loo & Loewen, 2002). Additional items were derived from a study of integrative medicine team practice (Gaboury, et al, 2010). Items on integrative team collaboration, integrative treatment planning, personal development, and clinical skills development were developed for the study. |
Monthly for the first 6 months, then each 3 months for the rest of the first year, then every 6 months | No |
| Other | Medical records chart audit (Fidelity) | Composite: Evidence of principles and best practices of integrative medicine: Whole person assessment and treatment; patient-practitioner health partnership; use of both conventional and CAM methods; health promotion and prevention interventions; use of natural and least invasive treatments where possible (support for body's innate healing capacity); patient personal care support team/team-based approach; extended visits/spending adequate time with patients; access to comprehensive, integrated, care. |
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 | No |
| Primary | 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 | No | |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Service Utilization Data and Health Insurance Claims Data | 3-, 6-, and 12-months; biennially | No |