Clinical trial NCT00754741: Multi-arm Intervention Diabetes Adherence Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Keywords: medication adherence
motivational interviewing
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-09-18
Enrollment: 1692
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Glycated Hemoglobin Levels
timeFrame: at 18 months post randomization
measure: LDL-cholesterol Levels
timeFrame: at 18 months post randomization
Secondary outcomes:
measure: Adherence to Oral Anti-diabetic Medications
timeFrame: at 6 months post randomization
measure: Adherence to Lipid-lowering Drugs
timeFrame: at 6 months post randomization
measure: Cardiovascular Morbidity and Mortality (Exploratory)
timeFrame: at 24 months post randomization
measure: Glycated Hemoglobin Levels
timeFrame: at 6 months post randomization
measure: LDL Cholesterol Levels
timeFrame: at 6 months post randomization
measure: Glycated Hemoglobin Levels
timeFrame: at 12 months post randomization
measure: LDL Cholesterol Levels
timeFrame: at 12 months post randomization
measure: Adherence to Oral Anti-diabetic Medications
timeFrame: at 12 months post randomization
measure: Adherence to Oral Anti-diabetic Medications
timeFrame: at 18 months post randomization
measure: Adherence to Lipid-lowering Drugs
timeFrame: at 12 months post randomization
measure: Adherence to Lipid-lowering Drugs
timeFrame: at 18 months post randomization
measure: Cardiovascular Morbidity and Mortality (Exploratory)
timeFrame: at 36 months post randomization
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Janis Campbell, RN
role: STUDY_DIRECTOR
affiliation: Henry Ford Hospital
name: Manel Pladeval, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Hospital
name: L. Keoki Williams, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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