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Diabetes Toolkit at Discharge

Primary Purpose

Diabetes Mellitus, Type 2, Insulin Dependent Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DM Discharge Toolkit
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Insulin, Hospital discharge, Transitions of care

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: English speaking patients 18 years of age and older Expected survival >90 days Need for new insulin at time of hospital discharge Exclusion Criteria: Patients with the inability to give informed consent Non-English speaking Not diagnosed with diabetes Not been newly prescribed insulin

Sites / Locations

  • Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DM Discharge Toolkit

Current Standard of Care Discharge DM Training

Arm Description

Up to 60 participants will be recruited for the intervention group. Participants will receive the current standard of care DM education for insulin at Northwestern Memorial Hospital and the adjunctive education with the DM Discharge Toolkit.

Up to 60 participants will be recruited for the control group. Participants will receive the current standard of care DM education for insulin use during current discharge care processes at Northwestern Memorial Hospital.

Outcomes

Primary Outcome Measures

Mean glucose levels
Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge

Secondary Outcome Measures

Number of hypoglycemic episodes
Number of glucoses < 70 mg/dl
Number of hyperglycemic episodes
Number of blood glucose levels >200 mg/dL
Healthcare utilization
Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits).
HbA1c
Hemoglobin A1c blood test
Time in hyperglycemia
Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement
Time in hypoglycemia
Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement
Mean amplitude of glycemic excursion
MAGE, outcome from continuous glucose monitor placement
Glycemic variability
A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.
Diabetes Symptoms Questionnaire
The Diabetes Symptoms Questionnaire consists of 9 questions where patients answer on a scale between 1-5, with higher numbers indicating a greater rate of occurrence.
Summary of Diabetes Self Care Activities
The Summary of Diabetes Self Care Activities consists of 7 questions where patients tally the number of days in the past week that they performed various diabetes self care tasks, such as checking blood glucose and taking medications.
Diabetes Distress Scale
The Diabetes Distress Scale is a questionnaire with 17 questions where patients answer on a scale between 1-6, with higher numbers indicating higher distress related to diabetes diagnosis.
Hospital Consumer Assessment of Healthcare Providers and Systems
Patient satisfaction survey
Partner Diabetes Distress Scale
The Partner Diabetes Distress Scale is a questionnaire with 21 questions where a spouse or partner of someone with diabetes answers on a scale between 0-4, with higher numbers indicating higher distress related to partner's diabetes diagnosis.
Perceived Stress Scale
The Perceived Stress Scale is a questionnaire with 10 questions where a patient answers on a scale between 0-4 with higher numbers indicating a greater rate of occurrence.
Infection
Rate of infection (bacterial, viral, other)

Full Information

First Posted
November 17, 2022
Last Updated
January 31, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05663931
Brief Title
Diabetes Toolkit at Discharge
Official Title
Implementation and Testing of a Diabetes Discharge Intervention to Improve Safety During Transitions of Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this randomized clinical trial is to implement the DM Discharge Toolkit into hospital discharge and assess the effect of the DM Discharge Toolkit on patients newly requiring insulin.
Detailed Description
This study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either current standard of care discharge DM training (control) or current standard of care discharge DM training and the DM Discharge Toolkit (intervention) before or immediately after being sent home to assume self-DM care with insulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Insulin Dependent Diabetes
Keywords
Insulin, Hospital discharge, Transitions of care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DM Discharge Toolkit
Arm Type
Experimental
Arm Description
Up to 60 participants will be recruited for the intervention group. Participants will receive the current standard of care DM education for insulin at Northwestern Memorial Hospital and the adjunctive education with the DM Discharge Toolkit.
Arm Title
Current Standard of Care Discharge DM Training
Arm Type
No Intervention
Arm Description
Up to 60 participants will be recruited for the control group. Participants will receive the current standard of care DM education for insulin use during current discharge care processes at Northwestern Memorial Hospital.
Intervention Type
Other
Intervention Name(s)
DM Discharge Toolkit
Intervention Description
The DM Discharge Toolkit is a multi-modal intervention consisting of a 3-D printed DM survival "kit" that stores DM self-care supplies (e.g., glucose meter) and technical skills (e.g., injection) simulation materials (e.g. simulation skin), whose use is integrated with a website (https://mydiabeteskit.com) containing standardized DM "Survival" education content.
Primary Outcome Measure Information:
Title
Mean glucose levels
Description
Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of hypoglycemic episodes
Description
Number of glucoses < 70 mg/dl
Time Frame
14, 30 and 90 days
Title
Number of hyperglycemic episodes
Description
Number of blood glucose levels >200 mg/dL
Time Frame
14, 30 and 90 days
Title
Healthcare utilization
Description
Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits).
Time Frame
14, 30 and 90 days
Title
HbA1c
Description
Hemoglobin A1c blood test
Time Frame
90 days
Title
Time in hyperglycemia
Description
Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement
Time Frame
14 days
Title
Time in hypoglycemia
Description
Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement
Time Frame
14 days
Title
Mean amplitude of glycemic excursion
Description
MAGE, outcome from continuous glucose monitor placement
Time Frame
14 days
Title
Glycemic variability
Description
A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge.
Time Frame
14 days
Title
Diabetes Symptoms Questionnaire
Description
The Diabetes Symptoms Questionnaire consists of 9 questions where patients answer on a scale between 1-5, with higher numbers indicating a greater rate of occurrence.
Time Frame
14 days, 30 days
Title
Summary of Diabetes Self Care Activities
Description
The Summary of Diabetes Self Care Activities consists of 7 questions where patients tally the number of days in the past week that they performed various diabetes self care tasks, such as checking blood glucose and taking medications.
Time Frame
14 days, 30 days
Title
Diabetes Distress Scale
Description
The Diabetes Distress Scale is a questionnaire with 17 questions where patients answer on a scale between 1-6, with higher numbers indicating higher distress related to diabetes diagnosis.
Time Frame
14 days, 30 days
Title
Hospital Consumer Assessment of Healthcare Providers and Systems
Description
Patient satisfaction survey
Time Frame
14 days, 30 days
Title
Partner Diabetes Distress Scale
Description
The Partner Diabetes Distress Scale is a questionnaire with 21 questions where a spouse or partner of someone with diabetes answers on a scale between 0-4, with higher numbers indicating higher distress related to partner's diabetes diagnosis.
Time Frame
Baseline, 30 days, 90 days
Title
Perceived Stress Scale
Description
The Perceived Stress Scale is a questionnaire with 10 questions where a patient answers on a scale between 0-4 with higher numbers indicating a greater rate of occurrence.
Time Frame
Baseline, 30 days, 90 days
Title
Infection
Description
Rate of infection (bacterial, viral, other)
Time Frame
30 and 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking patients 18 years of age and older Expected survival >90 days Need for new insulin at time of hospital discharge Exclusion Criteria: Patients with the inability to give informed consent Non-English speaking Not diagnosed with diabetes Not been newly prescribed insulin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie Herrmann, MS
Phone
312-503-0191
Email
s-herrmann@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amisha Wallia, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amisha Wallia, MD
Phone
312-503-2756
Email
a-wallia@northwestern.edu

12. IPD Sharing Statement

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Diabetes Toolkit at Discharge

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