Reducing Treatment Risk in Older Adults With Diabetes

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Behavioral: Conversation Aid
* Other: Attention Control Educational Handout


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two arms within the comparative effectiveness RCT. All eligible PCPs will receive academic detailing. Eligible and consenting patients of these PCPs will be randomly allocated to intervention vs attention control arms grouped by PCP. (There will be a secondary, parallel comparison group to measure temporal trends in care for similar patients at other facilities in our care system not involved in the clinical trial.)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-Visit Conversation Aid<br>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. | Behavioral: Conversation Aid<br>* 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.<br>|
| Active Comparator: General Health Education Handout<br>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<br>* Attention control is an existing health education handout that provides some general health advice geared towards older patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial