Reducing Treatment Risk in Older Adults With Diabetes (RETRO-DM)

Kaiser Permanente

Status: Completed

Conditions: Hypoglycemia; Polypharmacy; Type 2 Diabetes Treated With Insulin; Primary Health Care

Treatments: Behavioral: Conversation Aid; Other: Attention Control Educational Handout

Study type: Interventional

Funder types: Other

Identifiers

NCT04585191

CDR-2019C1-16126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 75 years
• type 2 diabetes with last measured Hemoglobin A1c (HbA1c) ≤ 8.0%
• currently prescribed insulin and/or sulfonylureas (SUs)
• Kaiser Permanente Northern California member

Exclusion criteria

• Given the requirements of this funding mechanism, we will not be able to develop new patient materials in languages other than English, and patients unable to communicate in English will be excluded.
• Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
• Excluded by their primary care provider

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Pre-Visit Conversation Aid

Experimental group

Description:

Patients in the intervention arm will receive a newly developed, 1-page conversation aid/communication tool entitled "Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me?" 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.

Treatment:

Behavioral: Conversation Aid

General Health Education Handout

Active Comparator group

Description:

Patients in the attention control arm will receive an existing 1-page health education handout entitled "Embracing Life as You Age" which provides some general advice geared towards older patients such as remaining physically active, limiting sun exposure, and eating well.

Treatment:

Other: Attention Control Educational Handout