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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypoglycemia; Type 2 Diabetes Treated With Insulin; Primary Health Care; Polypharmacy
• Intervention / Treatment: Other: Attention Control Educational Handout; Behavioral: Conversation Aid

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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94080
      • Kaiser Permanente South San Francisco
    • San Leandro, California, United States, 94577
      • Kaiser Permanente Northern California
    • Union City, California, United States, 94587
      • Kaiser Permanente Union City
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Vallejo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: General Health Education Handout; 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.	Other: Attention Control Educational Handout; Attention control is an existing health education handout that provides some general health advice geared towards older patients.
Experimental: Pre-Visit Conversation Aid; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing	Aggregate binary measure of diabetes medication deprescribing between baseline and 6-month follow-up. Greater de-prescribing is better. De-prescribing defined as any combination of: Discontinuation of either insulin or a sulfonylureas (SU); Reduction in dose of insulin or SU,; Switch from a higher risk to lower risk version of insulin (e.g. from sliding scale insulin or basal-bolus insulin to twice daily basal insulin) and/or higher risk to lower risk oral medicine (e.g. switching from SU to other oral medicine less associated with hypoglycemia).	6 months after initial primary care visit
Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia	Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else	Preceding 6 month period (asked 6 months after initial primary care visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Treatment Satisfaction Questionnaire Scores	Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [8 items, scores 0 - 36, higher score is better]	Asked 6 months after initial primary care visit
Number of Participants With Hypoglycemic-related Hospitalizations	Hypoglycemic-related hospitalizations in the 6 months following the first study-related visit.	6 months following the first study-related visit
RAND Patient Satisfaction Questionnaire	Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [5 item, score 5- 25, higher is worse]	6 months following the first study-related visit
Perceived Efficacy in Patient - Physician Interactions	Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions (5 - Item Survey, score 5-25, higher is better)	6 months following the first study-related visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c Level	HbA1c Change from baseline to study completion, an average of 1 year	1 year following the first study-related visit

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Richard W Grant, MD MPH, Division of Research, Kaiser Permanente Northern California

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: clinical trial
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia; Diabetes Mellitus
• Other Study ID Numbers: CDR-2019C1-16126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No