Multi-arm Intervention Diabetes Adherence Study - Full Text View

Purpose

The purpose of this study is to compare the effectiveness of two different interventions to improve adherence to diabetes medications among patients with diabetes and poor metabolic control.

Condition	Intervention	Phase
Diabetes	Behavioral: Adherence information Behavioral: Adherence information plus motivational interviewing	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase III Clinical Trial of the Effectiveness of Adherence Data and Motivational Interviewing to Improve Medication Adherence and Both Glycated Hemoglobin and Cholesterol Control

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes

U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:

Glycated hemoglobin levels [ Time Frame: at 18 months post randomization ] [ Designated as safety issue: No ]
LDL-cholesterol levels [ Time Frame: at 18 months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adherence to oral anti-diabetic medications [ Time Frame: at 6 months post randomization ] [ Designated as safety issue: No ]
Adherence to lipid-lowering drugs [ Time Frame: at 6 months post randomization ] [ Designated as safety issue: No ]
Cardiovascular morbidity and mortality (exploratory) [ Time Frame: at 24 months post randomization ] [ Designated as safety issue: No ]
Total costs [ Time Frame: at 12 months post randomization ] [ Designated as safety issue: No ]
Glycated hemoglobin levels [ Time Frame: at 6 months post randomization ] [ Designated as safety issue: No ]
LDL cholesterol levels [ Time Frame: at 6 months post randomization ] [ Designated as safety issue: No ]
Glycated hemoglobin levels [ Time Frame: at 12 months post randomization ] [ Designated as safety issue: No ]
LDL cholesterol levels [ Time Frame: at 12 months post randomization ] [ Designated as safety issue: No ]
Adherence to oral anti-diabetic medications [ Time Frame: at 12 months post randomization ] [ Designated as safety issue: No ]
Adherence to oral anti-diabetic medications [ Time Frame: at 18 months post randomization ] [ Designated as safety issue: No ]
Adherence to lipid-lowering drugs [ Time Frame: at 12 months post randomization ] [ Designated as safety issue: No ]
Adherence to lipid-lowering drugs [ Time Frame: at 18 months post randomization ] [ Designated as safety issue: No ]
Cardiovascular morbidity and mortality (exploratory) [ Time Frame: at 36 months post randomization ] [ Designated as safety issue: No ]
Total costs [ Time Frame: at 24 months post randomization ] [ Designated as safety issue: No ]
Total costs [ Time Frame: at 36 months post randomization ] [ Designated as safety issue: No ]

Enrollment:	1692
Study Start Date:	July 2008
Study Completion Date:	December 2012
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Usual care All Physicians are given limited training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software when they see patients assigned to this arm
Active Comparator: Adherence	Behavioral: Adherence information Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
Active Comparator: Adherence Plus	Behavioral: Adherence information plus motivational interviewing Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.

Detailed Description:

Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes.

Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 3-arm randomized clinical trial to test the effectiveness of providing primary care physicians (PCPs) with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications.

Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Patients will be randomized to one of the following three study arms: 1) Usual care - PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support; 2) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system; and 3) Intervention - PCPs will be provided adherence information and prompts electronically when using the electronic prescribing system plus physicians and patients will receive support from an adherence clinic.

Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients' adherence and goal levels. The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in the last 18 month.
At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the last 6 months.
Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d
Continuous health plan enrollment currently and in the previous calendar year with no more than a 1 month lapse of coverage, and benefits that include both medical and pharmacy coverage.

Exclusion Criteria:

Patients who have been institutionalized in a nursing home or in a long-term care facility for more than 3 months in the preceding 18 month period.
Participation in a disease management program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754741

Locations

United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202

Sponsors and Collaborators

Henry Ford Health System

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Director:	Janis Campbell, RN	Henry Ford Health System
Principal Investigator:	Manel Pladeval, MD, MS	Henry Ford Hospital
Principal Investigator:	L. Keoki Williams, MD, MPH	Henry Ford Hospital

More Information

Publications:

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 Dec;27(12):2800-5.

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 Jun 3;117(22):2884-92. Epub 2008 May 27.

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 May;23(5):588-94. Epub 2008 Mar 4.

Choudhry NK, Patrick AR, Antman EM, Avorn J, Shrank WH. Cost-effectiveness of providing full drug coverage to increase medication adherence in post-myocardial infarction Medicare beneficiaries. Circulation. 2008 Mar 11;117(10):1261-8. Epub 2008 Feb 19.

Ho PM, Magid DJ, Shetterly SM, Olson KL, Peterson PN, Masoudi FA, Rumsfeld JS. Importance of therapy intensification and medication nonadherence for blood pressure control in patients with coronary disease. Arch Intern Med. 2008 Feb 11;168(3):271-6.

Odegard PS, Capoccia K. Medication taking and diabetes: a systematic review of the literature. Diabetes Educ. 2007 Nov-Dec;33(6):1014-29; discussion 1030-1. Review.

Williams LK, Joseph CL, Peterson EL, Wells K, Wang M, Chowdhry VK, Walsh M, Campbell J, Rand CS, Apter AJ, Lanfear DE, Tunceli K, Pladevall M. Patients with asthma who do not fill their inhaled corticosteroids: a study of primary nonadherence. J Allergy Clin Immunol. 2007 Nov;120(5):1153-9. Epub 2007 Oct 22.

Piette JD. Interactive behavior change technology to support diabetes self-management: where do we stand? Diabetes Care. 2007 Oct;30(10):2425-32. Epub 2007 Jun 22. No abstract available.

Borrelli B, Riekert KA, Weinstein A, Rathier L. Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. J Allergy Clin Immunol. 2007 Nov;120(5):1023-30. Epub 2007 Sep 29.

West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in women with type 2 diabetes. Diabetes Care. 2007 May;30(5):1081-7. Epub 2007 Mar 2.

Munro S, Lewin S, Swart T, Volmink J. A review of health behaviour theories: how useful are these for developing interventions to promote long-term medication adherence for TB and HIV/AIDS? BMC Public Health. 2007 Jun 11;7:104. Review.

Channon SJ, Huws-Thomas MV, Rollnick S, Hood K, Cannings-John RL, Rogers C, Gregory JW. A multicenter randomized controlled trial of motivational interviewing in teenagers with diabetes. Diabetes Care. 2007 Jun;30(6):1390-5. Epub 2007 Mar 10.

van Dulmen S, Sluijs E, van Dijk L, de Ridder D, Heerdink R, Bensing J. Patient adherence to medical treatment: a review of reviews. BMC Health Serv Res. 2007 Apr 17;7:55. Review.

Grant R, Adams AS, Trinacty CM, Zhang F, Kleinman K, Soumerai SB, Meigs JB, Ross-Degnan D. Relationship between patient medication adherence and subsequent clinical inertia in type 2 diabetes glycemic management. Diabetes Care. 2007 Apr;30(4):807-12. Epub 2007 Jan 26.

Williams LK, Joseph CL, Peterson EL, Moon C, Xi H, Krajenta R, Johnson R, Wells K, Booza JC, Tunceli K, Lafata JE, Johnson CC, Ownby DR, Enberg R, Pladevall M. Race-ethnicity, crime, and other factors associated with adherence to inhaled corticosteroids. J Allergy Clin Immunol. 2007 Jan;119(1):168-75. Epub 2006 Nov 2.

Ho PM, Rumsfeld JS, Masoudi FA, McClure DL, Plomondon ME, Steiner JF, Magid DJ. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006 Sep 25;166(17):1836-41.

Miller NH, Hill M, Kottke T, Ockene IS. The multilevel compliance challenge: recommendations for a call to action. A statement for healthcare professionals. Circulation. 1997 Feb 18;95(4):1085-90.

Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. Review.

Responsible Party:	keoki williams, Senior Scientist, Henry Ford Health System
ClinicalTrials.gov Identifier:	NCT00754741 History of Changes
Other Study ID Numbers:	DK64695, R01DK064695, 5R01DK064695-06
Study First Received:	September 16, 2008
Last Updated:	April 9, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Henry Ford Health System:

medication adherence
motivational interviewing

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013

Multi-arm Intervention Diabetes Adherence Study (MIDAS)