RecruitingNot ApplicableNCT05933174

Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes


Sponsor

Ian J. Neeland, MD

Enrollment

220 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Sulfonylurea medications are unsafe for older patients with diabetes. They are associated not only with hypoglycemia, but also with falls and increased cardiovascular risk. Yet they continue to be prescribed frequently. Indeed, older adults with type 2 diabetes, who are especially prone to adverse effects, are more likely to be prescribed sulfonylureas than younger patients. This is unfortunate since over the past several years, newer, safer, and more effective classes of medications (GLP-1 agonists and SGLT2-inhibitors) have emerged. The investigators acknowledge that sulfonylureas are inexpensive and that their low cost is a driver of continued use. However, the investigators believe patients and providers should have discussions about the risks of sulfonylureas and safer and more effective alternatives, to make diabetes care safer overall in ambulatory settings. Our research is designed to promote such discussions. The investigators will first identify patients taking sulfonylureas regularly. Next, using recommendations from AHRQ and the Canadian Deprescribing Network, the investigators will empower patients to discuss their medications with their providers through a simple question prompt sheet. Patients will be divided into an intervention group which receives explicit prompting questions, and a control group that receives a general brochure on diabetes medications. Health care providers will receive education about newer diabetes medications through case-based discussions and academic detailing. Finally the investigators will measure key outcomes including the proportion of patients who have discussions about sulfonylureas and alternatives, rates of discontinuation, and measures of control of diabetes and associated cardiovascular risks. The investigators will also evaluate the experiences of patients and providers qualitatively through brief, semi-structured interviews. Should our multi-faceted, patient-oriented intervention prove effective in promoting discussions of sulfonylureas and alternatives, and also discontinuation of sulfonylureas and switching to newer alternatives, the investigators will incorporate our prompting questions into routine care for patients taking sulfonylureas. Our intervention can be easily disseminated to other settings and therefore has considerable potential to improve safety among patients with type 2 diabetes nationwide.


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program to help doctors switch type 2 diabetes patients from sulfonylurea medications (a class of diabetes pills that can cause low blood sugar and weight gain) to safer, more modern alternatives. The goal is to improve patient safety by reducing the risks associated with sulfonylureas. **You may be eligible if...** - You are 45 years or older - You have type 2 diabetes diagnosed on or before December 31, 2021 - You are currently prescribed a sulfonylurea medication - You have had at least 2 visits with a primary care provider at UH since 2021 **You may NOT be eligible if...** - You have type 1 diabetes - Your doctor has a reason why changing your medications is not appropriate - You are unwilling to discuss your diabetes medications with your doctor - You cannot provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPrompt-sheet

Simple prompt sheet with which participants will encouraged to use to guide a conversation with their provider at their next visit for routine diabetes care. These questions are based on recommendations from the Agency for Healthcare Research and Quality's Question Builder App and also on recommendations from the Canadian Deprescribing Network which specifically addresses SU use.

OTHERUsual education

Control group patients will be sent an information brochure with content from the NIDDK about diabetes medications (https://www.niddk.nih.gov/health-information/diabetes/overview/insulin-medicines-treatments).


Locations(1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT05933174


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