Clinical trial NCT05933174: Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes
Official title: Promoting Alternatives to Sulfonylureas to Improve Patient Safety in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type2diabetes
Keywords: Sulfonylureas
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-07-06
Enrollment: 220
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The objectives of this study are to systematically (a) identify middle-aged and older adults taking SU within a large integrated health system, and empower them to explore alternative, evidence-based treatments with their primary care providers to address and implement the ADA practice guideline as an actionable target to improve patient safety; and (b) engage our primary care providers in a systematic quality implementation and improvement program that includes education about contemporary T2D guideline recommendations, benefits, and drawbacks of different classes of agents, and formulary alternatives to SU. These objectives will be accomplished in the following 3 aims:

1. Empower patients to discuss treatments options with their primary care provider.

   Using an electronic data warehouse, the investigators will identify patients aged ≥45 years with type 2 diabetes who are currently prescribed SU and implement a strategy to encourage patients to discuss SU and alternatives with their primary care providers using a question-based prompt sheet. A control group will receive an overview sheet of diabetes medications.
2. Engage primary care providers in a quality implementation and improvement program.

   The program includes education about contemporary T2D guideline recommendations, benefits, and drawbacks of different classes of agents, and formulary alternatives to SU. An academic detailer will visit each primary care practice up to twice during the study period to provide targeted education about alternatives to SU to promote safety.
3. Measure key process outcomes and patient-centered outcomes at regular intervals.

Participants will be surveyed every 3 months during their first year of participation to identify if they had discussed alternatives. The investigators hypothesize that half of intervention group patients will have had such discussions compared with only 25% in the control group. Other outcomes will include assessment of hypoglycemia symptoms, discontinuation rates of SU, initiation of new medications, diabetes and financial distress (via surveys), and clinical outcomes (extracted from the electronic medical record) including glycosylated hemoglobin (Hb A1c), body weight, blood pressure, and lipids.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Type 1 diabetes
* PCP provides a reason why patient participation is inappropriate (e.g., known cost barriers without any alternatives, prior discussion with patient about alternatives, etc.)
* Patient unable or unwilling to have conversation with their PCP regarding SU
* Unable to provide informed consent

Primary outcomes:
measure: Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients who switched from a SU to an alternative medication
timeFrame: 12 months
measure: Proportion of patients who discontinued a SU
timeFrame: 12 months
measure: Proportion of patients who experienced a hypoglycemia event by self-report
timeFrame: 12 months
measure: Hb A1c
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
measure: Blood pressure (systolic and diastolic)
timeFrame: 12 months
measure: Lipid levels
timeFrame: 12 months
measure: The Personal Financial Well-being Scale
timeFrame: 12 months
measure: Diabetes Distress Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospital Cleveland Medical Center
name: Ian Neeland, MD
role: PRINCIPAL_INVESTIGATOR
References: