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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• Age ≥ 45 years

• Type 2 diabetes (diagnosed on or before 12/31/2021)

• Current/active prescription for one or more SU medications

• Established care (≥2 visits) with UH primary care provider (PCP) since 2021

Locations
United States
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Ian Neeland, MD
ian.neeland@uhhospitals.org
216-844-5965
Backup
Amanda Davies, MBA
Amanda.Davies@UHhospitals.org
216-844-7635
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 220
Treatments
Experimental: Prompt-sheet
Question-prompt group patients will receive a simple prompt sheet with the questions with which they 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.
Active_comparator: Usual 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).
Related Therapeutic Areas
Sponsors
Leads: Ian J. Neeland, MD
Collaborators: American Heart Association

This content was sourced from clinicaltrials.gov