Multi-arm Intervention Diabetes Adherence Study (MIDAS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
keoki williams, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00754741
First received: September 16, 2008
Last updated: April 9, 2013
Last verified: April 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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:

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 July 23, 2014