Reducing Treatment Risk in Older Adults With Diabetes

Hypoglycemia Clinical Trial

— RETRO-DM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04585191
• Other study ID #: CDR-2019C1-16126
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: September 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• age = 75
• type 2 diabetes with last measured HbA1c = 8.0%
• currently prescribed insulin and/or 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

Related Conditions & MeSH terms

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

Intervention

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 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente South San Francisco	San Francisco	California
United States	Kaiser Permanente Northern California	San Leandro	California
United States	Kaiser Permanente Union City	Union City	California
United States	Kaiser Permanente Vallejo	Vallejo	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1c Change from baseline to study completion, an average of 1 year	Change in HbA1c level between baseline and follow-up	1 year following the first study-related visit
Primary	Clinical Outcome: Number of Participants with glycemic regimen de-prescribing	Aggregate measure of diabetes medication deprescribing between baseline and 6-month follow-up, defined as any combination of: Discontinuation of either insulin or 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
Primary	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	Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire	Diabetes Treatment Satisfaction Questionnaire scores	Asked 6 months after initial primary care visit
Secondary	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
Secondary	Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire	RAND Patient Satisfaction Questionnaire	6 months following the first study-related visit
Secondary	Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions	Perceived Efficacy in Patient - Physician Interactions 5 - Item Survey	6 months following the first study-related visit