Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study

Michele Heisler, Timothy P Hofer, Mandi L Klamerus, Julie Schmittdiel, Joe Selby, Mary M Hogan, Hayden B Bosworth, Adam Tremblay, Eve A Kerr, Michele Heisler, Timothy P Hofer, Mandi L Klamerus, Julie Schmittdiel, Joe Selby, Mary M Hogan, Hayden B Bosworth, Adam Tremblay, Eve A Kerr

Abstract

Background: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.

Methods: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates.

Discussion: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.

Trial registration: The ClinicalTrials.gov registration number is NCT00495794.

Figures

Figure 1
Figure 1
Factors influencing providers' medication prescribing and patients' adherence to medications.
Figure 2
Figure 2
Intervention Logic Model.
Figure 3
Figure 3
Medication Management Tool [Initial Screen].

References

    1. Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: quality of care in the 1990s. Ann Intern Med. 2002;136(8):565–574.
    1. Saydah SH, Fradkin J, Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291(3):335–342. doi: 10.1001/jama.291.3.335.
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr. et al.The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report. JAMA. 2003;289(19):2560–2571. doi: 10.1001/jama.289.19.2560.
    1. Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of Medication Adherence on Hospitalization Risk and Healthcare Cost. Medical Care. 2005;43(6):521–530. doi: 10.1097/.
    1. Stephenson J. Noncompliance May Cause Half of Antihypertensive Drug "Failures". JAMA. 1999;282(4):313–314. doi: 10.1001/jama.282.4.313.
    1. Rubin RR. Adherence to pharmacologic therapy in patients with type 2 diabetes mellitus. Am J Med. 2005;118(Suppl 5A):27S–34S. doi: 10.1016/j.amjmed.2005.04.012.
    1. Grant RW, Buse JB, Meigs JB. Quality of diabetes care in U.S. academic medical centers: low rates of medical regimen change. Diabetes Care. 2005;28(2):337–442. doi: 10.2337/diacare.28.2.337.
    1. Berlowitz DR, Ash AS, Hickey EC, Glickman M, Friedman R, Kader B. Hypertension Management in Patients With Diabetes: The need for more aggressive therapy. Diabetes Care. 2003;26(2):355–359. doi: 10.2337/diacare.26.2.355.
    1. Phillips LS, Branch WT, Cook CB, Doyle JP, El-Kebbi IM, Gallina DL, Miller CD, Ziemer DC, Barnes CS. Clinical inertia. Ann Intern Med. 2001;135(9):825–834.
    1. Goldstein MK, Lavori P, Coleman R, Advani A, Hoffman BB. Improving adherence to guidelines for hypertension drug prescribing: cluster-randomized controlled trial of general versus patient-specific recommendations. Am J Manag Care. 2005;11(11):677–685.
    1. Shojania KG, Ranji SR, McDonald KM, Grimshaw JM, Sundaram V, Rushakoff RJ, Owens DK. Effects of Quality Improvement Strategies for Type 2 Diabetes on Glycemic Control: A Meta-Regression Analysis. JAMA. 2006;296(4):427–440. doi: 10.1001/jama.296.4.427.
    1. Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. 2009;169(19):1748–1755. doi: 10.1001/archinternmed.2009.316.
    1. Roumie CL, Elasy TA, Greevy R, Griffin MR, Liu X, Stone WJ, Wallston KA, Dittus RS, Alvarez V, Cobb J. et al.Improving blood pressure control through provider education, provider alerts, and patient education: a cluster randomized trial. Ann Intern Med. 2006;145(3):165–175.
    1. Stanford University UCSF Evidence-based Practice Center. Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies. Vol. 2. Diabetes Mellitus: AHRQ; 2004.
    1. Stanford University UCSF Evidence-based Practice Center. Hypertensive Care. Vol. 3. Rockville, MD: AHRQ; 2005. Closing the Quality Gap: A Critical Analysis of Quality Improvement Strategies.
    1. Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. Cochrane Database Syst Rev. 2002. p. CD000011.
    1. Bosworth HB, Olsen MK, Gentry P, Orr M, Dudley T, McCant F, Oddone EZ. Nurse administered telephone intervention for blood pressure control: a patient-tailored multifactorial intervention. Patient Educ Couns. 2005;57(1):5–14. doi: 10.1016/j.pec.2004.03.011.
    1. Bosworth HB, Olsen MK, Grubber JM, Neary AM, Orr MM, Powers BJ, Adams MB, Svetkey LP, Reed SD, Li Y. et al.Two self-management interventions to improve hypertension control: a randomized trial. Ann Intern Med. 2009;151(10):687–695.
    1. Krass I, Taylor SJ, Smith C, Armour CL. Impact on medication use and adherence of Australian pharmacists' diabetes care services. J Am Pharm Assoc (2003) 2005;45(1):33–40. doi: 10.1331/1544345052843093.
    1. Rothman RL, Malone R, Bryant B, Shintani AK, Crigler B, Dewalt DA, Dittus RS, Weinberger M, Pignone MP. A randomized trial of a primary care-based disease management program to improve cardiovascular risk factors and glycated hemoglobin levels in patients with diabetes. Amer J Med. 2005;118(3):276–284. doi: 10.1016/j.amjmed.2004.09.017.
    1. Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol. 2003;71(5):843–861. doi: 10.1037/0022-006X.71.5.843.
    1. Miller WR, Yahne CE, Moyers TB, Martinez J, Pirritano M. A randomized trial of methods to help clinicians learn motivational interviewing. J Consult Clin Psychol. 2004;72(6):1050–1062. doi: 10.1037/0022-006X.72.6.1050.
    1. Miller LG, Liu H, Hays RD, Golin CE, Beck CK, Asch SM, Ma Y, Kaplan AH, Wenger NS. How Well Do Clinicians Estimate Patients' Adherence to Combination Antiretroviral Therapy? J Gen Int Med. 2002;17(1):1–11. doi: 10.1046/j.1525-1497.2002.09004.x.
    1. Farmer KC. Methods for measuring and monitoring medication regimen adherence in clinical trials and clinical practice. Clin Ther. 1999;21(6):1074–1090. doi: 10.1016/S0149-2918(99)80026-5. discussion 1073.
    1. Choo PW, Rand CS, Inui TS, Lee ML, Cain E, Cordeiro-Breault M, Canning C, Platt R. Validation of patient reports, automated pharmacy records, and pill counts with electronic monitoring of adherence to antihypertensive therapy. Med Care. 1999;37(9):846–857. doi: 10.1097/00005650-199909000-00002.
    1. Steiner JF, Prochazka AV. The assessment of refill compliance using pharmacy records: methods, validity, and applications. J Clin Epidemiol. 1997;50(1):105–116. doi: 10.1016/S0895-4356(96)00268-5.
    1. Benner JS, Glynn RJ, Mogun H, Neumann PJ, Weinstein MC, Avorn J. Long-term persistence in use of statin therapy in elderly patients. JAMA. 2002;288(4):455–461. doi: 10.1001/jama.288.4.455.
    1. Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002;288(4):462–467. doi: 10.1001/jama.288.4.462.
    1. Pladevall M, Williams LK, Potts LA, Divine G, Xi H, Lafata JE. Clinical outcomes and adherence to medications measured by claims data in patients with diabetes. Diabetes Care. 2004;27(12):2800–2805. doi: 10.2337/diacare.27.12.2800.
    1. Kerr EA, Smith DM, Hogan MM, Krein SL, Pogach L, Hofer TP, Hayward RA. Comparing clinical automated, medical record, and hybrid data sources for diabetes quality measures. Joint Comm J Qual Improv. 2002;28(10):555–565.
    1. Schectman JM, Schorling JB, Nadkarni MM, Voss JD. Can prescription refill feedback to physicians improve patient adherence? Amer J Med Sci. 2004;327(1):19–24. doi: 10.1097/00000441-200401000-00005.
    1. Handley M, MacGregor K, Schillinger D, Sharifi C, Wong S, Bodenheimer T. Using action plans to help primary care patients adopt healthy behaviors: a descriptive study. J Am Board Fam Med. 2006;19(3):224–231. doi: 10.3122/jabfm.19.3.224.
    1. Bodenheimer T, Handley MA. Goal-setting for behavior change in primary care: an exploration and status report. Patient Educ Couns. 2009;76(2):174–180. doi: 10.1016/j.pec.2009.06.001.
    1. Deci EL, Ryan RM. The "what" and "why" of goal pursuits: Human needs and the self-determination of behavior. Psychol Inq. 2000;11:227–268. doi: 10.1207/S15327965PLI1104_01.
    1. Ryan RM, Deci EL. Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Amer Psychol. 2000;55(1):68–78. doi: 10.1037/0003-066X.55.1.68.
    1. Williams GC, Patrick H, Niemiec CP, Williams LK, Divine G, Lafata JE, Heisler M, Tunceli K, Pladevall M. Reducing the Health Risks of Diabetes: How Self-determination Theory May Help Improve Medication Adherence and Quality of Life. Diabetes Educ. 2009.
    1. Bandura A. A Social Cognitive Theory. Englewood Cliffs, NJ: Prentice-Hall; 1986. Social Foundations of Thought and Action.
    1. Bandura A. Self-efficacy: the exercise of control. New York:: WH Freeman and Co; 1997.
    1. Lorig KR, Ritter P, Stewart AL, Sobel DS, Brown BW Jr, Bandura A, Gonzalez VM, Laurent DD, Holman HR. Chronic disease self-management program: 2-year health status and health care utilization outcomes. Med Care. 2001;39(11):1217–1223. doi: 10.1097/00005650-200111000-00008.
    1. Chodosh J, Morton SC, Mojica W, Maglione M, Suttorp MJ, Hilton L, Rhodes S, Shekelle P. Meta-analysis: chronic disease self-management programs for older adults. Ann Intern Med. 2005;143(6):427–438.
    1. Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002;25(7):1159–1171. doi: 10.2337/diacare.25.7.1159.
    1. Resnicow K. 1-PASS coding system for motivational interviewing: introduction and scoring. Rollins School of Public Health, Emory University; 2002. pp. 1–7.
    1. Little RJ, Rubin DB. Causal effects in clinical and epidemiological studies via potential outcomes: concepts and analytical approaches. Annu Rev Public Health. 2000;21:121–145. doi: 10.1146/annurev.publhealth.21.1.121.
    1. Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol. 2004;57(8):785–794. doi: 10.1016/j.jclinepi.2003.12.013.
    1. Campbell M, Grimshaw J, Steen N. Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action) J Health Serv Res Policy. 2000;5(1):12–16.
    1. Eccles M, Grimshaw J, Campbell M, Ramsay C. Research designs for studies evaluating the effectiveness of change and improvement strategies. Qual Saf Health Care. 2003;12(1):47–52. doi: 10.1136/qhc.12.1.47.
    1. Knox SA, Chondros P. Observed intra-cluster correlation coefficients in a cluster survey sample of patient encounters in general practice in Australia. BMC Med Res Methodol. 2004;4(1):30. doi: 10.1186/1471-2288-4-30.
    1. Krein SL, Hofer TP, Kerr EA, Hayward RA. Whom should we profile? Examining diabetes care practice variation among primary care providers, provider groups, and health care facilities. Health Serv Res. 2002;37(5):1159–1180. doi: 10.1111/1475-6773.01102.
    1. Kerr EA, Zikmund-Fisher BJ, Klamerus ML, Subramanian U, Hogan MM, Hofer TP. The role of clinical uncertainty in treatment decisions for diabetic patients with uncontrolled blood pressure. Ann Intern Med. 2008;148(10):717–727.
    1. Montano DE, Selby JV, Somkin CP, Bhat A, Nadel M. Acceptance of flexible sigmoidoscopy screening for colorectal cancer. Cancer Detect Prev. 2004;28(1):43–51. doi: 10.1016/j.cdp.2003.11.005.
    1. Palitz AM, Selby JV, Grossman S, Finkler LJ, Bevc M, Kehr C, Conell CA. The Colon Cancer Prevention Program (CoCaP): rationale, implementation, and preliminary results. HMO Pract. 1997;11(1):5–12.
    1. Meresman JF, Hunkeler EM, Hargreaves WA, Kirsch AJ, Robinson P, Green A, Mann EZ, Getzell M, Feigenbaum P. A case report: implementing a nurse telecare program for treating depression in primary care. Psychiatr Q. 2003;74(1):61–73. doi: 10.1023/A:1021145722959.
    1. Pearson B, Katz SE, Soucie V, Hunkeler E, Meresman J, Rooney T, Amick BC. Evidence-based care for depression in Maine: dissemination of the Kaiser Permanente Nurse Telecare Program. Psychiatr Q. 2003;74(1):91–102. doi: 10.1023/A:1021149923867.
    1. Schmittdiel JA, Uratsu CS, Fireman BH, Selby JV. The effectiveness of diabetes care management in managed care. Am J Manag Care. 2009;15(5):295–301.
    1. Heisler M, Hogan MM, Hofer TP, Schmittdiel JA, Pladevall M, Kerr EA. When more is not better: treatment intensification among hypertensive patients with poor medication adherence. Circulation. 2008;117(22):2884–2892. doi: 10.1161/CIRCULATIONAHA.107.724104.
    1. Schmittdiel JA, Uratsu CS, Karter AJ, Heisler M, Subramanian U, Mangione CM, Selby JV. Why don't diabetes patients achieve recommended risk factor targets? Poor adherence versus lack of treatment intensification. J Gen Intern Med. 2008;23(5):588–594. doi: 10.1007/s11606-008-0554-8.
    1. Heisler M, Smith DM, Hayward RA, Krein SL, Kerr EA. Racial disparities in diabetes care processes, outcomes, and treatment intensity. Med Care. 2003;41(11):1221–1232. doi: 10.1097/01.MLR.0000093421.64618.9C.
    1. Institute of Medicine Committee on Enhancing Federal Healthcare Quality Programs CJEJ. Leadership by example: coordinating government roles in improving health care quality. Washington, DC: National Academies Press; 2003.
    1. Choe HM, Mitrovich S, Dubay D, Hayward RA, Krein SL, Vijan S. Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care. 2005;11(4):253–260.
    1. McLean DL, McAlister FA, Johnson JA, King KM, Makowsky MJ, Jones CA, Tsuyuki RT. A randomized trial of the effect of community pharmacist and nurse care on improving blood pressure management in patients with diabetes mellitus: study of cardiovascular risk intervention by pharmacists-hypertension (SCRIP-HTN) Arch Intern Med. 2008;168(21):2355–2361. doi: 10.1001/archinte.168.21.2355.
    1. Duffy SA, Ronis DL, Valenstein M, Lambert MT, Fowler KE, Gregory L, Bishop C, Myers LL, Blow FC, Terrell JE. A tailored smoking, alcohol, and depression intervention for head and neck cancer patients. Cancer Epidem Biomark Prevent. 2006;15(11):2203–2208. doi: 10.1158/1055-9965.EPI-05-0880.
    1. Skinner C, Campbell MK, Rimer BK, Curry S, Prochaska JO. How effective is tailored print communication? Annals of Behavioral Medicine. 1999;21(4):209–298. doi: 10.1007/BF02895960.
    1. American Medical Association.
    1. National Diabetes Education Program.

Source: PubMed

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

3
Předplatit