Hypoglycemia Prevention in High-Risk Type 2 Diabetes Patients

The primary research question is whether using a "Hypoglycemia Champion" (HC) to target high risk patients with type 2 diabetes (T2D) is a feasible and effective model of care to reduce hypoglycemia risk in this population.

The goals of this study are to:

• Develop an evidence-based, expert consensus clinical guideline, "Hypoglycemia on a Page" (HOAP), for hypoglycemia prevention in patients with T2D at high risk of hypoglycemia. Guideline development will include stakeholders across multiple Kaiser Permanente regions.
• Develop a workflow for use by a "Hypoglycemia Champion" (HC), a clinical pharmacist who will apply the HOAP guideline in the proactive, protocol-driven management of Kaiser Permanente Northern California (KPNC) members identified as having high hypoglycemic risk;
• Conduct a pragmatic, randomized trial of the proactive HC intervention vs. usual care on diabetes regimen safety among KPNC members at high risk of hypoglycemia. The investigators hypothesize that at 6 months, high-risk members assigned to the HC intervention will be prescribed safer diabetes regimens (defined as discontinuation of sulfonylureas and/or rapid-/short-acting or mixed insulins) compared to usual care.

The study design will include: 1) Engaging expert clinical stakeholders and experienced KP guideline developers to create an evidence-based hypoglycemia prevention algorithm (HOAP) analogous to KPNC's successful "PHASE on a Page" guideline for cardiovascular risk management; 2) Crafting a population-based workflow protocol for proactive outreach by the HC (specifically trained clinical pharmacist) to apply this new guideline to high-risk members; and 3) Performing a pragmatic randomized trial comparing proximal clinical outcomes (diabetes medication changes) available directly from the EHR between the intervention arm (pro-active outreach by the HC) vs. controls (usual care, including availability of the HOAP). The primary analysis will be intent-to-treat and will assess differences in the proportion of patients using safer diabetes regimens (relative to their baseline regimen) between study arms. The investigators will also examine heterogeneity of treatment effects by age, race/ethnicity, and prior severe hypoglycemia events. Deliverables include: 1) Inter-regional dissemination of the HOAP algorithm and the HC workflow protocol, 2) High quality, pragmatic RCT results to inform operational decision-making, and 3) Presentations and manuscripts to further disseminate findings. This study is highly relevant to TPMG and KP because: 1) Hypoglycemia is common, morbid, and costly, 2) Providers are challenged to address the competing demands of prescribing diabetes medications to meet glycemic targets while avoiding iatrogenic hypoglycemia, 3) No regional strategies currently exist to reduce hypoglycemia risk. This work has strategic implications for our organization because a new HEDIS measure proposed for measurement year 2023 will assess emergency department admissions for hypoglycemia in older adults with diabetes. Our proposal will address this gap in organizational clinical care by developing and evaluating a practical, proactive, population management approach to hypoglycemia prevention for members with T2D at high risk of hypoglycemia.

Inclusion criteria

• Active KPNC members with valid MRNs at baseline (06/01/2023),
• age >=18 years,
• in the KPNC diabetes registry,
• likely type 2 diabetes (determined using a validated algorithm
• high risk for hypoglycemia, determined using the hypoglycemia risk stratification tool developed by the investigator team

Exclusion criteria

• Dementia or impaired cognition,
• psychosis or schizophrenia diagnosis,
• end-stage renal disease,
• "no contact" preferences on file,
• no primary care physician or home facility,
• receiving care at skill nursing facilities,
• deceased,
• enrolled in concurrent pharmacy deprescribing pilots