Reducing Treatment Risk in Older Adults With Diabetes

Not Applicable

Completed

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

Interventions: Behavioral: Conversation Aid
Other: Attention Control Educational Handout

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Pre-Visit Conversation Aid	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 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.
General Health Education Handout	Attention Control Educational 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.

Primary Outcome Measures

Name	Time	Method
Clinical Outcome: Number of Participants With Glycemic Regimen De-prescribing	6 months after initial primary care visit	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: 1. Discontinuation of either insulin or a sulfonylureas (SU) 2. Reduction in dose of insulin or SU, 3. 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).
Patient-Reported Outcome: Number of Participants With Self-Reported Hypoglycemia	Preceding 6 month period (asked 6 months after initial primary care visit)	Patient report of any low blood sugar episode in past 6 months that resulted in passing out or needing help from someone else

Secondary Outcome Measures

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

Locations (4): Kaiser Permanente South San Francisco
🇺🇸
San Francisco, California, United States
Kaiser Permanente Northern California
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San Leandro, California, United States
Kaiser Permanente Union City
🇺🇸
Union City, California, United States
Kaiser Permanente Vallejo
🇺🇸
Vallejo, California, United States
Kaiser Permanente South San Francisco
🇺🇸San Francisco, California, United States