IMPACT - Integrative Medicine PrimAry Care Trial (IMPACT)

February 6, 2013 updated by: Sally Dodds, University of Arizona

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • University of Arizona Integrative Health Center (UAIHC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary care patients
Primary care patients who are members of UAIHC.
Other: Integrative medicine primary care model
An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total healthcare costs from the payer's perspective-total paid costs according to claims data.
Time Frame: 12 months of paid costs pre and post beginning membership at UAIHC
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
Time Frame: 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).
Baseline, 3-, 6-, and 12-months
Clinical indicators and biomarkers
Time Frame: 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.
3-, 6-, and 12-months
Service Utilization Data and Health Insurance Claims Data
Time Frame: 3-, 6-, and 12-months; biennially
3-, 6-, and 12-months; biennially

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Experiences (Fidelity)
Time Frame: Monthly for the first 6 mos., then each 3 months for the rest of the first year, then every 6 months.

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.
Provider Experiences (Fidelity)
Time Frame: Monthly for the first 6 months, then each 3 months for the rest of the first year, then every 6 months

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
Medical records chart audit (Fidelity)
Time Frame: 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Investigators

  • Principal Investigator: Victoria Maizes, MD, University of Arizona Arizona Center for Integrative Medicine
  • Study Director: Sally E Dodds, PhD, University of Arizona Arizona Center for Integrative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 6, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Coors001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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