NCT04585191

Reducing Treatment Risk in Older Adults With Diabetes

Reducing Treatment Risk in Older Patients With Diabetes: Comparative Effectiveness of Academic Detailing With and Without Pre-Visit Patient Preparation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.

Detailed description

In this comparative effectiveness clinical trial, primary care physicians (PCPs) will receive 2 academic detailing sessions 6 months apart. Eligible patients (age 75 years or greater, type 2 diabetes, prescribed insulin or sulfonylureas \[SUs\], and last measured HbA1c \<=8%) of these PCPs will be randomized to receive either a pre-visit conversation aid/communication tool that elicits values and preferences regarding safe insulin/SU deprescribing \[Intervention\] or a general health education handout ("Embracing Life as You Age") \[Attention Control\]. Patient-reported outcomes (e.g., self-reported hypoglycemia episodes) and clinical outcomes (e.g., changes in glycemic regimen) will be compared between study arms. If successful, this study will provide evidence to support strategies for safer treatment in older adults with type 2 diabetes.

Conditions

• Type 2 Diabetes Treated With Insulin
• Hypoglycemia
• Primary Health Care
• Polypharmacy

Interventions

Type	Name	Description
BEHAVIORAL	Conversation Aid	Intervention is a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" that patients receive prior to a scheduled appointment with their primary care physician (PCP). This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps.
OTHER	Attention Control Educational Handout	Attention control is an existing health education handout that provides some general health advice geared towards older patients.

Timeline

• Start date: 2020-11-02
• Primary completion: 2024-03-30
• Completion: 2024-09-01
• First posted: 2020-10-14
• Last updated: 2025-03-21
• Results posted: 2025-03-21

Locations

4 sites across 1 country: United States