Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial

Contemp Clin Trials. 2025 Jun:153:107913. doi: 10.1016/j.cct.2025.107913. Epub 2025 Apr 11.

Abstract

Background: As adults with type 2 diabetes (T2D) age, they are increasingly vulnerable to treatment-related hypoglycemia and subsequent complications including falls and hospitalizations. Care planning helps patients communicate what is most important for their medical care with their family, friends, and clinicians and could help reduce treatment-related complications of T2D in older adults.

Methods: We applied an expanded care planning paradigm to the specific clinical problem of type 2 diabetes management in older patients. Applying user-centered design methods, we developed an educational, web-based program called "PREPARE for Your Diabetes Care," incorporating input and feedback from patient and provider key informants. A randomized controlled trial (RCT) of this program vs. usual care is being conducted among Kaiser Permanente Northern California members ≥75 years of age, prescribed insulin or sulfonylureas, and at high risk for hypoglycemia. The primary outcome of the RCT is clinically significant hypoglycemia episodes (self-reported 3+ symptomatic episodes of hypoglycemia, self-reported severe hypoglycemia, and/or ED or hospitalization for hypoglycemia). Secondary outcomes will include medication de-intensification, 5-item RAND Patient Satisfaction, and 5-item Perceived Efficacy in Patient - Physician Interactions.

Results: This study has completed enrollment and randomized 673 participants; trial completion is expected in late 2025.

Conclusions: This research will evaluate an expanded care planning intervention to reduce treatment-related hypoglycemia in older adults with T2D. If successful, this web-based expanded care planning strategy could be applied to a wide variety of geriatric conditions requiring individualization of treatment based on patients' preferences.

Trial registration numbers: NCT05263310; Pre-results.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Aged
  • Aged, 80 and over
  • California
  • Diabetes Mellitus, Type 2* / drug therapy
  • Diabetes Mellitus, Type 2* / therapy
  • Female
  • Hospitalization / statistics & numerical data
  • Humans
  • Hypoglycemia* / chemically induced
  • Hypoglycemia* / epidemiology
  • Hypoglycemia* / prevention & control
  • Hypoglycemic Agents* / administration & dosage
  • Hypoglycemic Agents* / adverse effects
  • Hypoglycemic Agents* / therapeutic use
  • Insulin / adverse effects
  • Insulin / therapeutic use
  • Male
  • Patient Care Planning* / organization & administration
  • Patient Education as Topic* / methods
  • Patient Satisfaction
  • Physician-Patient Relations
  • Randomized Controlled Trials as Topic
  • Research Design
  • Sulfonylurea Compounds / adverse effects
  • Sulfonylurea Compounds / therapeutic use

Substances

  • Hypoglycemic Agents
  • Insulin
  • Sulfonylurea Compounds

Associated data

  • ClinicalTrials.gov/NCT05263310