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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Prompt-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.
• Другое 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).

Первичные конечные точки

• Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Proportion of patients who switched from a SU to an alternative medication [Срок оценки: 12 months]
• Proportion of patients who discontinued a SU [Срок оценки: 12 months]
• Proportion of patients who experienced a hypoglycemia event by self-report [Срок оценки: 12 months]
• Hb A1c [Срок оценки: 12 months]
• BMI [Срок оценки: 12 months]
• Blood pressure (systolic and diastolic) [Срок оценки: 12 months]
• Lipid levels [Срок оценки: 12 months]
• The Personal Financial Well-being Scale [Срок оценки: 12 months]
• Diabetes Distress Scale [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University Hospitals Cleveland Medical Center — Cleveland

Идентификаторы

NCT: NCT05933174 · STUDY20230836 · Neeland AHA 23SCISA1144816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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