Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
Primary Purpose
Diabetes, Dementia, Hypoglycemia; Drug
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STRIDE
Sponsored by
About this trial
This is an interventional other trial for Diabetes focused on measuring older adults, long term care facility, high risk medications, hypoglycemia, deprescribing, diabetes, dementia
Eligibility Criteria
Inclusion Criteria:
- Clinical staff at the LTCF (MDs, PAs, NPs, clinical pharmacists) - (Targeted providers for STRIDE program)
- Clinical staff that participated in the STRIDE program (Providers doing stakeholder exit interviews)
Exclusion Criteria:
- Consistent with the pragmatic nature of the trial, there are no exclusion criteria.
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
STRIDE Intervention
Arm Description
Educational intervention for clinicians
Outcomes
Primary Outcome Measures
Change in proportion of long term care facility (LTCF) residents with Alzheimer's disease adn related dementias (ADRD) and diabetes with high risk medications (HRM) use
HRM use will include any sulfonylurea use (i.e., glyburide, glipizide, glimepiride, or chlorpropamide) and any insulin use.
Secondary Outcome Measures
Acceptability of the STRIDE Educational Program
The extent to which the program is agreeable to LTCF staff- using the Acceptability of Intervention Measure (AIM)
Appropriateness of the STRIDE Educational Program
The extent to which the program is suitable for a particular purpose, i.e., to improve the frequency at which LTCF staff attempt diabetes medication regimen deprescribing- using the Intervention Appropriateness Measure (IAM)
Feasibility of the STRIDE Educational Program
The extent to which the program is practical at the LTCF level- using the Feasibility of Intervention Measure (FIM)
Full Information
NCT ID
NCT05535478
First Posted
August 26, 2022
Last Updated
February 22, 2023
Sponsor
Joslin Diabetes Center
Collaborators
Brown University, Theoria Medical
1. Study Identification
Unique Protocol Identification Number
NCT05535478
Brief Title
Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
Official Title
Deprescribing of Diabetes Treatment Regimens in Long Term Care (LTC) Residents With Alzheimer's Disease or Related Dementias (ADRD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Brown University, Theoria Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives To 1) examine the ability of the STRIDE (Simplification of Treatment Regimens and Individualized Diabetes Education) educational program to increase deprescribing of high hypoglycemia risk glucose-lowering medications (HRMs) among long term care facility (LTCF) residents with ADRD, 2) assess key implementation constructs (secondary outcomes) of the STRIDE program, including acceptability, appropriateness, and feasibility, and 3) validate the primary HRM use outcome measure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Dementia, Hypoglycemia; Drug
Keywords
older adults, long term care facility, high risk medications, hypoglycemia, deprescribing, diabetes, dementia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
STRIDE Intervention
Arm Type
Other
Arm Description
Educational intervention for clinicians
Intervention Type
Behavioral
Intervention Name(s)
STRIDE
Intervention Description
a. Targeted providers for STRIDE program: i. Clinical staff at the LTCF who participate in deprescribing at the facilities (physicians (MDs), physician's assistants (PAs), nurse practitioners (NPs), clinical pharmacists): clinical staff members caring for LTCF residents with ADRD and diabetes at 6 LTCFs in the Ohio and Michigan areas will be invited via email from the LTCF leadership to participate in the STRIDE education program. The STRIDE program consist of practical algorithms and educational material, which they are free to view at any time, and participation in 2 webinars and monthly telementoring calls
Primary Outcome Measure Information:
Title
Change in proportion of long term care facility (LTCF) residents with Alzheimer's disease adn related dementias (ADRD) and diabetes with high risk medications (HRM) use
Description
HRM use will include any sulfonylurea use (i.e., glyburide, glipizide, glimepiride, or chlorpropamide) and any insulin use.
Time Frame
Baseline vs 6 months
Secondary Outcome Measure Information:
Title
Acceptability of the STRIDE Educational Program
Description
The extent to which the program is agreeable to LTCF staff- using the Acceptability of Intervention Measure (AIM)
Time Frame
6 months
Title
Appropriateness of the STRIDE Educational Program
Description
The extent to which the program is suitable for a particular purpose, i.e., to improve the frequency at which LTCF staff attempt diabetes medication regimen deprescribing- using the Intervention Appropriateness Measure (IAM)
Time Frame
6 months
Title
Feasibility of the STRIDE Educational Program
Description
The extent to which the program is practical at the LTCF level- using the Feasibility of Intervention Measure (FIM)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical staff at the LTCF (MDs, PAs, NPs, clinical pharmacists) - (Targeted providers for STRIDE program)
Clinical staff that participated in the STRIDE program (Providers doing stakeholder exit interviews)
Exclusion Criteria:
Consistent with the pragmatic nature of the trial, there are no exclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medha Munshi, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Deprescribing of Diabetes Regimens in Long Term Care Residents With Alzheimer's
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