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

Primary Purpose

Type2diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prompt-sheet
Usual education
Sponsored by
Ian J. Neeland, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type2diabetes focused on measuring Sulfonylureas

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prompt-sheet

Usual education

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management
Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management

Secondary Outcome Measures

Proportion of patients who switched from a SU to an alternative medication
Proportion of patients who switched from a SU to an alternative medication
Proportion of patients who discontinued a SU
Proportion of patients who discontinued a SU
Proportion of patients who experienced a hypoglycemia event by self-report
Proportion of patients who experienced a hypoglycemia event by self-report
Hb A1c
glycosylated hemoglobin
BMI
body mass index
Blood pressure (systolic and diastolic)
Blood pressure (systolic and diastolic)
Lipid levels
Lipid levels
The Personal Financial Well-being Scale
. The financial well-being scale is a free tool to help measure the financial well-being of people you serve. The scale, which was developed and rigorously tested by The Consumer Financial Protection Bureau, contains 10 questions to capture how people feel about their financial security and freedom of choice, plus 2 questions to assist with scoring. Responses to the questions can be converted into an overall financial well-being "score" between 0 and 100.
Diabetes Distress Scale
17-item self-report survey to assess an individual's level of stress related to living with diabetes. Each question has an answer rating from 1 ("not a problem") to 5 ("a very serious problem").

Full Information

First Posted
June 27, 2023
Last Updated
July 24, 2023
Sponsor
Ian J. Neeland, MD
Collaborators
American Heart Association
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1. Study Identification

Unique Protocol Identification Number
NCT05933174
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ian J. Neeland, MD
Collaborators
American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes
Keywords
Sulfonylureas

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prompt-sheet
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual education
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Prompt-sheet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual education
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management
Description
Proportion of patients who had a conversation with their primary care provider about SU use and alternatives for their diabetes management
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patients who switched from a SU to an alternative medication
Description
Proportion of patients who switched from a SU to an alternative medication
Time Frame
12 months
Title
Proportion of patients who discontinued a SU
Description
Proportion of patients who discontinued a SU
Time Frame
12 months
Title
Proportion of patients who experienced a hypoglycemia event by self-report
Description
Proportion of patients who experienced a hypoglycemia event by self-report
Time Frame
12 months
Title
Hb A1c
Description
glycosylated hemoglobin
Time Frame
12 months
Title
BMI
Description
body mass index
Time Frame
12 months
Title
Blood pressure (systolic and diastolic)
Description
Blood pressure (systolic and diastolic)
Time Frame
12 months
Title
Lipid levels
Description
Lipid levels
Time Frame
12 months
Title
The Personal Financial Well-being Scale
Description
. The financial well-being scale is a free tool to help measure the financial well-being of people you serve. The scale, which was developed and rigorously tested by The Consumer Financial Protection Bureau, contains 10 questions to capture how people feel about their financial security and freedom of choice, plus 2 questions to assist with scoring. Responses to the questions can be converted into an overall financial well-being "score" between 0 and 100.
Time Frame
12 months
Title
Diabetes Distress Scale
Description
17-item self-report survey to assess an individual's level of stress related to living with diabetes. Each question has an answer rating from 1 ("not a problem") to 5 ("a very serious problem").
Time Frame
12 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-identified gender
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Neeland, MD
Phone
216-844-5965
Email
ian.neeland@uhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Davies, MBA
Phone
216-844-7635
Email
Amanda.Davies@UHhospitals.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Neeland, MD
Organizational Affiliation
University Hospital Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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