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IMPACT - Integrative Medicine PrimAry Care Trial (IMPACT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Sally Dodds, University of Arizona.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01785485
First Posted: February 7, 2013
Last Update Posted: February 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sally Dodds, University of Arizona
  Purpose

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.


Condition Intervention
Adult Primary Care Patients Other: Integrative medicine primary care model

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: IMPACT: Integrative Medicine PrimAry Care Trial: A Comparative Effectiveness Study of an Integrative Primary Care Clinic

Further study details as provided by Sally Dodds, University of Arizona:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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).


  • 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.


  • Service Utilization Data and Health Insurance Claims Data [ Time Frame: 3-, 6-, and 12-months; biennially ]

Other Outcome Measures:
  • 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).


  • 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.


  • 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.



Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785485


Contacts
Contact: TBA
Contact: Sally E Dodds 520-621-6807 sdodds1@email.arizona.edu

Locations
United States, Arizona
University of Arizona Integrative Health Center (UAIHC)
Phoenix, Arizona, United States, 85012
Sponsors and Collaborators
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
  More Information

Publications:
Kroenke, K., Spitzer R.L. (2002). The PHQ-9: A new depression and diagnostic severity measure. Psychiatric Annals, 32, 509-521.
Loo, R & Loewen, P. (2002). A Confirmatory Factor-Analytic and Psychometric Examination of the Team Climate Inventory : Full and Short Versions. Small Group Research, 33: 254.
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.
Centers for Disease Control and Prevention (2012). Behavioral Risk Factor Surveillance System Survey Questionnaire. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Accessed October 15, 2012 from the World Wide Web at http://www.cdc.gov/brfss.
Anderson, N. R., & West, M. A. (1998). Measuring climate for work group innovation: Development and validation of the team climate inventory. Journal of Organizational Behavior, 19, 235-258.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sally Dodds, Associate Professor/Research Scholar of Medicine & Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT01785485     History of Changes
Other Study ID Numbers: Coors001
First Submitted: January 31, 2013
First Posted: February 7, 2013
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Sally Dodds, University of Arizona:
Integrative medicine
primary care
cost-effectiveness