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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
450
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.
Attention control is an existing health education handout that provides some general health advice geared towards older patients.
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, United States
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: 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).
Time frame: 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
Time frame: Preceding 6 month period (asked 6 months after initial primary care visit)
Diabetes Treatment Satisfaction Questionnaire Scores
Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire \[8 items, scores 0 - 36, higher score is better\]
Time frame: 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.
Time frame: 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 \[5 item, score 5- 25, higher is worse\]
Time frame: 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)
Time frame: 6 months following the first study-related visit
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