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

Patricia M Herman, Sally E Dodds, Melanie D Logue, Ivo Abraham, Rick A Rehfeld, Amy J Grizzle, Terry F Urbine, Randy Horwitz, Robert L Crocker, Victoria H Maizes, Patricia M Herman, Sally E Dodds, Melanie D Logue, Ivo Abraham, Rick A Rehfeld, Amy J Grizzle, Terry F Urbine, Randy Horwitz, Robert L Crocker, Victoria H Maizes

Abstract

Background: Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM.

Methods/design: This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works.

Discussion: The US health care system needs new models of care that are more patient-centered and empower patients to make positive lifestyle changes. These models have the potential to reduce the burden of chronic disease, lower the cost of healthcare, and offer a sustainable financial paradigm for our nation. This protocol has been designed to test whether the UAIHC can achieve this potential.

Trial registration: Clinical Trials.gov NCT01785485.

References

    1. Maizes V, Schneider C, Bell I, Weil A. Integrative medical education: development and implementation of a comprehensive curriculum at the University of Arizona. Academ Med. 2002;77(9):851–860. doi: 10.1097/00001888-200209000-00003.
    1. Boon H, Verhoef M, O'Hara D, Findlay B, Majid N. Integrative healthcare: arriving at a working definition. Alternative therapies in health and medicine. 2004;10(5):48.
    1. About Us: Definition of Integrative Medicine. [ ]
    1. What is Complementary and Alternative Medicine? [ ]
    1. What is integrative medicine? [ ]
    1. Horrigan B, Lewis S, Abrams D, Pechura C. Integrative Medicine in America. The Bravewell Collaborative: Minneapolis, MN; 2012.
    1. Deng G, Weber W, Sood A, Kemper KJ. Research on integrative healthcare: context and priorities. Explore: The Journal of Science and Healing. 2010;6(3):143–158. doi: 10.1016/j.explore.2010.03.007.
    1. Deng G, Weber W, Sood A, Kemper K. Integrative Healthcare Research: Context and Priorities. Institute of Medicine: Washington, DC; 2009.
    1. Khorsan R, Coulter ID, Crawford C, Hsiao AF. Systematic review of integrative health care research: randomized control trials, clinical controlled trials, and meta-analysis. Evidence-Based Complementary and Alternative Medicine. 2011;2010
    1. Marcus DM, McCullough L. An evaluation of the evidence in" evidence-based" integrative medicine programs. Academic Medicine. 2009;84(9):1229. doi: 10.1097/ACM.0b013e3181b185f4.
    1. Guarneri E, Horrigan BJ, Pechura CM. The efficacy and cost effectiveness of integrative medicine: a review of the medical and corporate literature. Explore: The Journal of Science and Healing. 2010;6(5):308. doi: 10.1016/j.explore.2010.06.012.
    1. Coulter ID, Khorsan R, Crawford C, Hsiao AF. Integrative health care under review. 2010.
    1. Cassidy CM. Social science theory and methods in the study of alternative and complementary medicine. The Journal of Alternative and Complementary Medicine. 1995;1(1):19–40. doi: 10.1089/acm.1995.1.19.
    1. Nahin RL, Straus SE. Research into complementary and alternative medicine: problems and potential. BMJ. 2001;322(7279):161–164. doi: 10.1136/bmj.322.7279.161.
    1. Mason S, Tovey P, Long AF. Evaluating complementary medicine: methodological challenges of randomised controlled trials. BMJ. 2002;325(7368):832–834. doi: 10.1136/bmj.325.7368.832.
    1. Harlan WR Jr. New opportunities and proven approaches in complementary and alternative medicine research at the National Institutes of Health. J Alternative & Complemen Med. 2001;7(1):53–59. doi: 10.1089/107555301300004538.
    1. Gatchel R, Maddrey A. Clinical outcome research in complementary and alternative medicine: an overview of experimental design and analysis. Alternative Ther Health Med. 1998;4(5):36.
    1. Vickers A, Cassileth B, Ernst E, Fisher P, Goldman P, Jonas W, Kang S, Lewith G, Schulz K, Silagy C. How should we research unconventional therapies. Int J Technol Assess Health Care. 1997;13:111–121. doi: 10.1017/S0266462300010278.
    1. Levin JS, Glass TA, Kushi LH, Schuck JR, Steele L, Jonas WB. Quantitative methods in research on complementary and alternative medicine: a methodological manifesto. Medical Care. 1997;35(11):1079–1094. doi: 10.1097/00005650-199711000-00001.
    1. Vickers A. Methodological issues in complementary and alternative medicine research: a personal reflection on 10 years of debate in the United Kingdom. J Alternative Complementary Med. 1996;2(4):515–524. doi: 10.1089/acm.1996.2.515.
    1. Alexander JA, Hearld LR. Methods and metrics challenges of delivery-system research. Implementation Science. 2012;7(1):15. doi: 10.1186/1748-5908-7-15.
    1. Hasson H. Systematic evaluation of implementation fidelity of complex interventions in health and social care. Implement Sci. 2010;5(1):67. doi: 10.1186/1748-5908-5-67.
    1. Dumas JE, Lynch AM, Laughlin JE, Phillips Smith E, Prinz RJ. Promoting intervention fidelity: conceptual issues, methods, and preliminary results from the EARLY ALLIANCE prevention trial. Am J Preven Med. 2001;20(1):38–47. doi: 10.1016/S0749-3797(00)00272-5.
    1. Santacroce SJ, Maccarelli LM, Grey M. Intervention fidelity. Nursing Res. 2004;53(1):63–66. doi: 10.1097/00006199-200401000-00010.
    1. Herman PM. Evaluating the Economics of Complementary and Integrative Medicine. Samueli Institute: Alexandria, VA; 2012.
    1. Rees L, Weil A. Integrated medicine: imbues orthodox medicine with the values of complementary medicine. BMJ. 2001;322(7279):119. doi: 10.1136/bmj.322.7279.119.
    1. Maizes V, Rakel D, Niemiec C. Integrative medicine and patient-centered care. In: IOM Summit on Integrative Medicine and the Health of the Public commissioned paper. Institute of Medicine: Washington, DC; 2009.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new medical research council guidance. BMJ. 2008;337
    1. Bell IR, Caspi O, Schwartz GER, Grant KL, Gaudet TW, Rychener D, Maizes V, Weil A. Integrative medicine and systemic outcomes research: issues in the emergence of a new model for primary health care. Arch Int Med. 2002;162(2):133. doi: 10.1001/archinte.162.2.133.
    1. Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole systems research: a discipline for studying complementary and alternative medicine. Altern Ther Health Med. 2003;9(4):32.
    1. Bond GR, Evans L, Salyers MP, Williams J, Kim HW. Measurement of fidelity in psychiatric rehabilitation. Ment Health Serv Res. 2000;2:75–87. doi: 10.1023/A:1010153020697.
    1. Sechrest L, West SG, Phillips MA, Redner R, Yeaton W. Some neglected problems in evaluation research: strength and integrity of treatments. Evaluation Studies Review Annual. 1979;4:15–35.
    1. Woolf SH, Johnson RE. Inattention to the fidelity of health care delivery is costing lives. Am J Public Health. 2007;97(10):1732.
    1. Adler SR. Integrative medicine and culture: toward an Anthropology of CAM. Med Anthro Quart. 2002;16(4):412. doi: 10.1525/maq.2002.16.4.412.
    1. Long AF. Outcome measurement in complementary and alternative medicine: unpicking the effects. J Altern Complement Med. 2002;8(6):777–786. doi: 10.1089/10755530260511793.
    1. Coulter ID, Khorsan R. In: Outcome Measurement in the Human Services. Magnabosco JL, Manderscheid RW, editor. Washington, DC: NASW Press; 2011. Complementary alternative and integrative medicine: current challenges for outcomes measurement; pp. 163–178.
    1. Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and the Congress. Washington, DC: Federal Coordinating Council for Comparative Effectiveness Research; 2009.
    1. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. New England J Med. 2000;342(25):1878–1886. doi: 10.1056/NEJM200006223422506.
    1. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. New England J Med. 2000;342(25):1887–1892. doi: 10.1056/NEJM200006223422507.
    1. Heinsman DT, Shadish WR. Assignment methods in experimentation: When do nonrandomized experiments approximate answers from randomized experiments? Psychological Methods. 1996;1(2):154.
    1. Tunis SR, Benner J, McClellan M. Comparative effectiveness research: policy context, methods development and research infrastructure. Statistics Med. 2010;29(19):1963–1976. doi: 10.1002/sim.3818.
    1. Teutsch SM, Berger ML, Weinstein MC. Comparative effectiveness: asking the right questions, choosing the right method. Health Affairs. 2005;24(1):128–132. doi: 10.1377/hlthaff.24.1.128.
    1. Chokshi DA, Avorn J, Kesselheim AS. Designing comparative effectiveness research on prescription drugs: lessons from the clinical trial literature. Health Affairs. 2010;29(10):1842–1848. doi: 10.1377/hlthaff.2010.0843.
    1. Maizes V, Caspi O. The principles and challenges of integrative medicine. Western J Med. 1999;171(3):148.
    1. Donaldson MS, Yordy KD, Lohr KN, Vanselow NA, editor. Committee on the Future of Primary Care. Primary Care: America's Health in a New Era. Washington, DC: Institute of Medicine; 1996.
    1. The defining principles of integrative medicine. [ ]
    1. Joint Principles of the Patient-Centered Medical Home. [ ]
    1. Dodds SE, Herman PM, Sechrest L, Abraham I, Logue MD, Grizzle AL, Rehfeld RA, Urbine TJ, Horwitz R, Crocker RL, Maizes VH. When a whole practice model is the intervention: developing fidelity evaluation components using program theory-driven science for an integrative medicine primary care clinic. Evidence-Based Complementary and Alternative Medicine. 2013;2013(Article ID 652047):11.
    1. Caliendo M, Kopeinig S. Some practical guidance for the implementation of propensity score matching. J Econ Surveys. 2008;22(1):31–72. doi: 10.1111/j.1467-6419.2007.00527.x.
    1. Adult Visit Questionnaire 2.0. [ ]
    1. Behavioral Risk Factor Surveillance System Survey Questionnaire. [ ]
    1. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Services Res. 2004;39(4p1):1005–1026. doi: 10.1111/j.1475-6773.2004.00269.x.
    1. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Services Res. 2005;40(6p1):1918–1930. doi: 10.1111/j.1475-6773.2005.00438.x.
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Social Behavior. 1983;24:385–396. doi: 10.2307/2136404.
    1. Littman AJ, White E, Satia JA, Bowen DJ, Kristal AR. Reliability and validity of 2 single-item measures of psychosocial stress. Epidemiology. 2006;17(4):398–403. doi: 10.1097/01.ede.0000219721.89552.51.
    1. Buysse DJ, Reynolds CF, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989;28(2):193–213. doi: 10.1016/0165-1781(89)90047-4.
    1. Hargraves JL, Hays RD, Cleary PD. Psychometric properties of the consumer assessment of health plans study (CAHPS®) 2.0 adult core survey. Health Services Res. 2003;38(6p1):1509–1528. doi: 10.1111/j.1475-6773.2003.00190.x.
    1. Huskisson E. Measurement of pain. The Lancet. 1974;304(7889):1127–1131. doi: 10.1016/S0140-6736(74)90884-8.
    1. Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale: application to patients with multiple sclerosis and systemic lupus erythematosus. Archives of neurology. 1989;46(10):1121. doi: 10.1001/archneur.1989.00520460115022.
    1. Kroenke K, Spitzer RL, Williams JBW. The Patient Health Questionnaire-2: validity of a two-item depression screener. Medical Care. 2003;41(11):1284–1292. doi: 10.1097/01.MLR.0000093487.78664.3C.
    1. Kroenke K, Spitzer RL, Williams J, Monahan PO, Löwe B. Anxiety disorders in primary care: prevalence, impairment, comorbidity, and detection. Ann Int Med. 2007;146(5):317. doi: 10.7326/0003-4819-146-5-200703060-00004.
    1. Ware JE Jr, Kosinski M, Keller SD. A 12-Item short-form health survey: construction of scales and preliminary tests of reliability and validity. Medical Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. 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 Psychiatric Res. 2003;12(2):85–91. doi: 10.1002/mpr.145.
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–353. doi: 10.2165/00019053-199304050-00006.
    1. Ritter PL, Stewart AL, Kaymaz H, Sobel DS, Block DA, Lorig KR. Self-reports of health care utilization compared to provider records. J Clin Epidemiol. 2001;54(2):136–141. doi: 10.1016/S0895-4356(00)00261-4.
    1. Bennett RM, Friend R, Jones KD, Ward R, Han BK, Ross RL. The revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009;11(4):120. doi: 10.1186/ar2734.
    1. Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. Psychiatric Annals. 2002;32(9):509–515.
    1. Kroenke K, Spitzer RL, Williams JBW. The PHQ‒9. J Gen Int Med. 2001;16(9):606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Spitzer RL, Kroenke K, Williams JBW, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Int Med. 2006;166(10):1092. doi: 10.1001/archinte.166.10.1092.
    1. D’Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care. Circulation. 2008;117(6):743–753. doi: 10.1161/CIRCULATIONAHA.107.699579.
    1. Anderson KM, Odell PM, Wilson PWF, Kannel WB. Cardiovascular disease risk profiles. American Heart J. 1991;121(1):293–298.
    1. Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement. Curr Opinion Cardiol. 2006;21(1):1. doi: 10.1097/01.hco.0000200416.65370.a0.
    1. Safran DG, Karp M, Coltin K, Chang H, Li A, Ogren J, Rogers WH. Measuring patients' experiences with individual primary care physicians. J Gen Int Med. 2006;21(1):13–21. doi: 10.1111/j.1525-1497.2005.00311.x.
    1. Mercer SW, Maxwell M, Heaney D, Watt GCM. The consultation and relational empathy (CARE) measure: development and preliminary validation and reliability of an empathy-based consultation process measure. Family Practice. 2004;21(6):699–705. doi: 10.1093/fampra/cmh621.
    1. Loo R, Loewen P. A confirmatory factor-analytic and psychometric examination of the team climate inventory full and short versions. Small Group Research. 2002;33(2):254–265. doi: 10.1177/104649640203300205.
    1. Rohland BM, Kruse GR, Rohrer JE. Validation of a single-item measure of burnout against the Maslach Burnout Inventory among physicians Stress and Health. 2004. pp. 75–79.
    1. National Center for Health Statistics. Ambulatory Health Care Data. Centers for Disease Control and Prevention; 2012.
    1. Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Medical Care. 2004;42(9):851–859. doi: 10.1097/01.mlr.0000135827.18610.0d.
    1. Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2. Hillsdale, New Jersey: Lawrence Erlbaum Associates; 1988.
    1. Heo M, Faith MS, Mott JW, Gorman BS, Redden DT, Allison DB. Hierarchical linear models for the development of growth curves: an example with body mass index in overweight/obese adults. Stat Med. 1911–1942;2003:22.
    1. Raudenbush SW, Bryk AS. Hierarchical Linear Models: Applications and Data Analysis Methods, Second Edition edn. Thousand Oaks, CA: Sage Publications; 2002.
    1. Singer JD. Using SAS PROC MIXED to fit multilevel models, hierarchical models, and individual growth curve models. J Educ Behav Stat. 1998;24(4):323–355.
    1. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med. 2000;19:3219–3236. doi: 10.1002/1097-0258(20001215)19:23<3219::AID-SIM623>;2-P.
    1. Efron B, Tibshirani RJ. An Introduction to the Bootstrap. Champman & Hall/CRC: Boca Raton; 1994.
    1. Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Prevent Med. 2007;45(4):247–251. doi: 10.1016/j.ypmed.2007.08.012.

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