ENhancing Outcomes Through Goal Assessment and Generating Engagement in Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Shared Decision Making
Intervention type(s): Behavioral
Intervention description(s): This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus Type 2