Rationale and design of the ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic trial

Contemp Clin Trials. 2017 Aug:59:57-63. doi: 10.1016/j.cct.2017.05.014. Epub 2017 May 29.

Abstract

Background: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making).

Objective: To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes.

Methods/design: ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data.

Conclusions: This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes.

Keywords: Behavioral intervention; Clinical pharmacist; Diabetes; Medication adherence; Pragmatic trial.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Diabetes Mellitus* / psychology
  • Diabetes Mellitus* / therapy
  • Female
  • Glycated Hemoglobin / analysis
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Medication Adherence* / psychology
  • Medication Adherence* / statistics & numerical data
  • Medication Therapy Management / organization & administration
  • Patient Care Planning
  • Patient Outcome Assessment
  • Patient Participation* / methods
  • Patient Participation* / psychology
  • Pharmaceutical Services / statistics & numerical data

Substances

  • Glycated Hemoglobin A
  • Hypoglycemic Agents