Diabetes Toolkit at Discharge

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation and Testing of a Diabetes Discharge Intervention to Improve Safety During Transitions of Care

Conditions
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Diabetes Mellitus, Type 2, Insulin Dependent Diabetes

Intervention / Treatment
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* Other: DM Discharge Toolkit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DM Discharge Toolkit<br>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. | Other: DM Discharge Toolkit<br>* 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.<br>|
| No Intervention: Current Standard of Care Discharge DM Training<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean glucose levels | Mean glucose levels based on home glucose meter and outpatient laboratory data post-discharge | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hypoglycemic episodes | Number of glucoses < 70 mg/dl | 14, 30 and 90 days | 
| Number of hyperglycemic episodes | Number of blood glucose levels >200 mg/dL | 14, 30 and 90 days | 
| Healthcare utilization | Number of post-discharge contacts with the healthcare system (i.e. phone calls, emergency room visits, re-admissions, outpatient clinician visits). | 14, 30 and 90 days | 
| HbA1c | Hemoglobin A1c blood test | 90 days | 
| Time in hyperglycemia | Time in hyperglycemia defined as > 200 mg/dl, outcome from continuous glucose monitor placement | 14 days | 
| Time in hypoglycemia | Time in hyperglycemia defined as < 70 mg/dl, outcome from continuous glucose monitor placement | 14 days | 
| Mean amplitude of glycemic excursion | MAGE, outcome from continuous glucose monitor placement | 14 days | 
| Glycemic variability | A continuous glucose monitor will be used to monitor glucose levels from discharge to 14 days post discharge. | 14 days | 
| 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. | 14 days, 30 days | 
| 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. | 14 days, 30 days | 
| 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. | 14 days, 30 days | 
| Hospital Consumer Assessment of Healthcare Providers and Systems | Patient satisfaction survey | 14 days, 30 days | 
| 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. | Baseline, 30 days, 90 days | 
| 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. | Baseline, 30 days, 90 days | 
| Infection | Rate of infection (bacterial, viral, other) | 30 and 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Hospital discharge, Transitions of care