ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus

Phase 4

Completed

Conditions: Diabetes Mellitus Type 2

Interventions: Behavioral: Shared Decision Making

Registration Number: NCT02910089

Lead Sponsor: AstraZeneca

Brief Summary: The purpose of this study is to evaluate whether a combination of pharmacist-delivered patient engagement techniques improves disease control and medication adherence among patients with poorly-controlled diabetes compared with usual care. These engagement techniques include shared decision-making and brief negotiated interviewing and are delivered telephonically.

Detailed Description: The US is facing a growing epidemic of type 2 diabetes. Among patients with poorly controlled diabetes, it is often not clear whether the problem is attributable to failure to appropriately intensify therapy, poor adherence to prescribed medications, unwillingness to accept new treatments or a combination of these factors. Multi-component pharmacist-delivered interventions, particularly those rooted in patient engagement, have been shown to be some of the most effective at improving adherence to chronic disease medications. Even though shared decision making and brief negotiated interviewing are complementary patient engagement techniques, the effectiveness of combining these 2 intervention approaches, especially in the management of diabetes, is unknown.

In this study of patients using at least one oral hypoglycemic therapy with poorly controlled disease, the investigators examine the impact of a shared decision making and behavioral interviewing intervention delivered telephonically by pharmacists, compared with usual care. Briefly, all patients allocated to the intervention will be mailed a patient decision aid to prime them for encounters with pharmacists. After receiving the decision aid, these patients will be asked to engage in and provide informed consent for at least 4 telephonic discussions with pharmacists about their diabetes treatment options, goals, and preferences, medication adherence, strategies for reducing adherence barriers, and the benefits of maintaining blood glucose control. The study is being conducted within a large insurer and consists of 700 patients each allocated to the intervention group and the control group. Analyses will be performed on an intent-to-treat basis.

After study completion, the investigators will also use predictive analytics to examine whether treatment response could be predicted based on patient characteristics, such as sociodemographic, clinical, medication use, and other motivational characteristics, which will provide information about which patients are most likely to benefit from the intervention.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared Decision Making/Brief Negotiated Interviewing	Shared Decision Making	This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).

Primary Outcome Measures

Name	Time	Method
Glycosylated Hemoglobin (HbA1c):	baseline and at the end of 12 months post index date	Pre- to post-intervention change in mean HbA1c levels

Secondary Outcome Measures

Name	Time	Method
Medication Adherence (PDC Measure)	during follow-up period of 12 months post index date	Mean Adherence (PDC) in each study arm in the follow-up period
Percentage (Proportion x 100) of Patients Achieving Optimal Adherence	during follow-up period of 12 months post index date	Percentage (Proportion x 100) of patients in each study arm achieving optimal adherence (PDC ≥0.80) in the follow-up period
Patients Achieving HbA1c	baseline and at the end of 12 months post index date	Percentage (Proportion x 100) of patients in each study arm achieving optimal HbA1c control in the follow-up period