Multi-arm Intervention Diabetes Adherence Study

Phase 3

Completed

Conditions: Diabetes

Interventions: Behavioral: Adherence information plus motivational interviewing
Behavioral: Adherence information

Registration Number: NCT00754741

Lead Sponsor: Henry Ford Health System

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1692

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adherence Plus	Adherence information plus motivational interviewing	-
Adherence	Adherence information	-

Primary Outcome Measures

Name	Time	Method
Glycated Hemoglobin Levels	at 18 months post randomization
LDL-cholesterol Levels	at 18 months post randomization

Secondary Outcome Measures

Name	Time	Method
Glycated Hemoglobin Levels	at 12 months post randomization
Adherence to Lipid-lowering Drugs	at 18 months post randomization	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.
LDL Cholesterol Levels	at 12 months post randomization
Adherence to Oral Anti-diabetic Medications	at 18 months post randomization	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.
Cardiovascular Morbidity and Mortality (Exploratory)	at 36 months post randomization