Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2013-02-28
2015-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Primary care patients
Primary care patients who are members of UAIHC.
Integrative medicine primary care model
An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.
Interventions
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Integrative medicine primary care model
An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.
Eligibility Criteria
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Inclusion Criteria
* Adults age 18 or older.
* Enrollment in primary care (members) at UAIHC;
* Adults age 18 or older.
* All clinical and support personnel.
Exclusion Criteria
* 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):
* Significant cognitive impairment to the extent that the individual is unable to understand consent and respond to questionnaires.
Fidelity Study Sample (Providers):
* None.
18 Years
ALL
Yes
Sponsors
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University of Arizona
OTHER
Responsible Party
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Sally Dodds
Associate Professor/Research Scholar of Medicine & Psychiatry
Principal Investigators
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Victoria Maizes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arizona Arizona Center for Integrative Medicine
Sally E Dodds, PhD
Role: STUDY_DIRECTOR
University of Arizona Arizona Center for Integrative Medicine
Locations
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University of Arizona Integrative Health Center (UAIHC)
Phoenix, Arizona, United States
Countries
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Central Contacts
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TBA
Role: CONTACT
References
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Kroenke, K., Spitzer R.L. (2002). The PHQ-9: A new depression and diagnostic severity measure. Psychiatric Annals, 32, 509-521.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
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Kroenke K, Spitzer RL, Williams JB, Monahan PO, Lowe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Intern Med. 2007 Mar 6;146(5):317-25. doi: 10.7326/0003-4819-146-5-200703060-00004.
Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
Williams DA, Arnold LM. Measures of fibromyalgia: Fibromyalgia Impact Questionnaire (FIQ), Brief Pain Inventory (BPI), Multidimensional Fatigue Inventory (MFI-20), Medical Outcomes Study (MOS) Sleep Scale, and Multiple Ability Self-Report Questionnaire (MASQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S86-97. doi: 10.1002/acr.20531. No abstract available.
Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976). 1983 Mar;8(2):145-50. doi: 10.1097/00007632-198303000-00005.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
Safran DG, Kosinski M, Tarlov AR, Rogers WH, Taira DH, Lieberman N, Ware JE. The Primary Care Assessment Survey: tests of data quality and measurement performance. Med Care. 1998 May;36(5):728-39. doi: 10.1097/00005650-199805000-00012.
Mercer SW, Maxwell M, Heaney D, Watt GC. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Fam Pract. 2004 Dec;21(6):699-705. doi: 10.1093/fampra/cmh621. Epub 2004 Nov 4.
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
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.
Gaboury I, Boon H, Verhoef M, Bujold M, Lapierre LM, Moher D. Practitioners' validation of framework of team-oriented practice models in integrative health care: a mixed methods study. BMC Health Serv Res. 2010 Oct 14;10:289. doi: 10.1186/1472-6963-10-289.
Bech P, Olsen LR, Kjoller M, Rasmussen NK. Measuring well-being rather than the absence of distress symptoms: a comparison of the SF-36 Mental Health subscale and the WHO-Five Well-Being Scale. Int J Methods Psychiatr Res. 2003;12(2):85-91. doi: 10.1002/mpr.145.
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.
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Herman PM, Dodds SE, Logue MD, Abraham I, Rehfeld RA, Grizzle AJ, Urbine TF, Horwitz R, Crocker RL, Maizes VH. IMPACT--Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model. BMC Complement Altern Med. 2014 Apr 7;14:132. doi: 10.1186/1472-6882-14-132.
Other Identifiers
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Coors001
Identifier Type: -
Identifier Source: org_study_id
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