ArticleContemporary clinical trials2025
Expanded care planning paradigm for older adults with type 2 diabetes: Rationale, design, and protocol of the PREPARE for Your Diabetes Care randomized trial.
Article in Contemporary clinical trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05263310 (Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia), which is not on this map. Not yet cited in PubMed.
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Clinical Trial of Expanded Advance Care Planning to Address Regimen Intensity in Older Patients at High Risk for Treatment-Induced Hypoglycemia
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6 authors.
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Abstract
backgroundAs 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.
methodsWe 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.
resultsThis study has completed enrollment and randomized 673 participants; trial completion is expected in late 2025.
conclusionsThis 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.
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