Multi-arm Intervention Diabetes Adherence Study

Diabetes Clinical Trial

— MIDAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754741
• Other study ID #: DK64695
• Secondary ID: R01DK0646955R01D
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2008
• Last updated: April 21, 2015
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2015
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1692
• Est. completion date: December 2012
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Adherence information
Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.
• 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.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. doi: 10.1161/CIRCULATIONAHA.107.735605. Epub 2008 Feb 19. — View Citation

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. — View Citation

Haynes RB, Ackloo E, Sahota N, McDonald HP, Yao X. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD000011. doi: 10.1002/14651858.CD000011.pub3. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD000011. — View Citation

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. doi: 10.1161/CIRCULATIONAHA.107.724104. Epub 2008 May 27. — View Citation

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. doi: 10.1001/archinternmed.2007.72. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1007/s11606-008-0554-8. Epub 2008 Mar 4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated Hemoglobin Levels		at 18 months post randomization	No
Primary	LDL-cholesterol Levels		at 18 months post randomization	No
Secondary	Adherence to Oral Anti-diabetic Medications	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 6 months post randomization	No
Secondary	Adherence to Lipid-lowering Drugs	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "6 months post randomization" represented use beginning at 3 months post-randomization and ending at 6 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 6 months post randomization	No
Secondary	Cardiovascular Morbidity and Mortality (Exploratory)		at 24 months post randomization	No
Secondary	Glycated Hemoglobin Levels		at 6 months post randomization	No
Secondary	LDL Cholesterol Levels		at 6 months post randomization	No
Secondary	Glycated Hemoglobin Levels		at 12 months post randomization	No
Secondary	LDL Cholesterol Levels		at 12 months post randomization	No
Secondary	Adherence to Oral Anti-diabetic Medications	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 12 months post randomization	No
Secondary	Adherence to Oral Anti-diabetic Medications	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 18 months post randomization	No
Secondary	Adherence to Lipid-lowering Drugs	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "12 months post randomization" represented use beginning at 9 months post-randomization and ending at 12 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 12 months post randomization	No
Secondary	Adherence to Lipid-lowering Drugs	Adherence is the estimated proportion of the prescribed dose taken over a 3-month period. Therefore, each estimate of medication adherence represented a 3-month window of use prior to and including the endpoint time (e.g., the adherence estimate at "18 months post randomization" represented use beginning at 15 months post-randomization and ending at 18 months post-randomization). Pharmacy claims data (i.e., days supply and refill frequency) were used to estimate adherence at each endpoint date.	at 18 months post randomization	No
Secondary	Cardiovascular Morbidity and Mortality (Exploratory)		at 36 months post randomization	No