RETRO-DM: Reducing Treatment Risk in Older Adults With Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 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 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.
|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Clinical Outcome: Number of Participants with glycemic regimen de-prescribing [6 months after initial primary care visit]
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).
- 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
- Patient-Centered Outcome: Number of Participants with improved scores on Diabetes Treatment Satisfaction Questionnaire [Asked 6 months after initial primary care visit]
Diabetes Treatment Satisfaction Questionnaire scores
- 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.
- Patient-Centered Outcome: Number of Participants with improved scores on the RAND Patient Satisfaction Questionnaire [6 months following the first study-related visit]
RAND Patient Satisfaction Questionnaire
- Patient-Centered Outcome: Number of Participants with improved scores on Perceived Efficacy in Patient - Physician Interactions [6 months following the first study-related visit]
Perceived Efficacy in Patient - Physician Interactions 5 - Item Survey
Other Outcome Measures
- HbA1c Change from baseline to study completion, an average of 1 year [1 year following the first study-related visit]
Change in HbA1c level between baseline and follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 75
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type 2 diabetes with last measured HbA1c ≤ 8.0%
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currently prescribed insulin and/or SUs
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Kaiser Permanente Northern California member
Exclusion Criteria:
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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.
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Similarly, patients unable to provide informed consent and/or participate in informed decision making due to cognitive or communication-related deficits will be excluded.
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Excluded by their primary care provider
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente South San Francisco | San Francisco | California | United States | 94080 |
| 2 | Kaiser Permanente Northern California | San Leandro | California | United States | 94577 |
| 3 | Kaiser Permanente Union City | Union City | California | United States | 94587 |
| 4 | Kaiser Permanente Vallejo | Vallejo | California | United States | 94589 |
Sponsors and Collaborators
- Kaiser Permanente
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Richard W Grant, MD MPH, Division of Research, Kaiser Permanente Northern California
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR-2019C1-16126