Overcoming therapeutic inertia in newly diagnosed type 2 diabetes: Protocol of a randomized, quality improvement trial

Contemp Clin Trials. 2025 Jan:148:107751. doi: 10.1016/j.cct.2024.107751. Epub 2024 Nov 17.

Abstract

Therapeutic inertia, the delay in the appropriate initiation and intensification of recommended therapies, is a major contributor to the lack of improvement in type 2 diabetes outcomes over the past decade. Therapeutic inertia during the period following diagnosis, when improvements in glycemic control can have lasting benefits, is often overlooked. Technology and team-based care approaches can effectively address therapeutic inertia. Here, we describe the protocol for a randomized, quality improvement trial targeting metformin-related therapeutic inertia among adults with recently diagnosed type 2 diabetes and a hemoglobin A1c <8 %. Service areas within an integrated healthcare delivery system were randomized to 1) usual care, 2) physician education on therapeutic inertia, and 3) physician education on therapeutic inertia paired with proactive outreach by a clinical pharmacist. The physician education sessions were offered to primary care providers working in the service areas randomized to Arm 2 and Arm 3, and proactive outreach by a clinical pharmacist was performed for patients of the providers in service areas randomized to Arm 3. Outcomes will be abstracted from the EHR at 6, 12, and 18 months following the physician education sessions. The primary outcome will be the proportion of patients with an HbA1c <7 % at each of the follow-up time points. Outcome abstraction and analyses will occur in late 2024. This trial seeks to rigorously evaluate care strategies that can shift stagnant type 2 diabetes outcomes. Our protocol, along with the pending results, may offer examples to other healthcare systems working to improve type 2 diabetes care.

Keywords: Clinical inertia; Diabetes; Quality improvement; Trial.

Publication types

  • Clinical Trial Protocol
  • Randomized Controlled Trial

MeSH terms

  • Delivery of Health Care, Integrated / organization & administration
  • Diabetes Mellitus, Type 2* / drug therapy
  • Diabetes Mellitus, Type 2* / therapy
  • Glycated Hemoglobin* / analysis
  • Glycemic Control / methods
  • Humans
  • Hypoglycemic Agents* / administration & dosage
  • Hypoglycemic Agents* / therapeutic use
  • Metformin* / therapeutic use
  • Pharmacists / organization & administration
  • Practice Patterns, Physicians' / standards
  • Primary Health Care / organization & administration
  • Quality Improvement* / organization & administration

Substances

  • Glycated Hemoglobin
  • Hypoglycemic Agents
  • Metformin