Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes

Study Overview
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Brief Summary
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The purpose of this study is evaluate the effectiveness of Diabetes-REM (Rescue, Engagement, and Management), a comprehensive community paramedic (CP) program to support adults in Southeast Minnesota (Mower, Freeborn, and Olmsted counties) and Northwest Wisconsin (Barron, Rusk, and Dunn) who have uncontrolled diabetes (HbA1c ≥ 9%) and have experienced an emergency department (ED) visit or hospitalization for any cause in the prior 6 months.

Official Title
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Community Paramedicine Program to Improve Diabetes Care Quality, Equity, and Outcomes

Conditions
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Diabetes, Diabetes Mellitus

Intervention / Treatment
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* Other: Diabetes-REM Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Patients): Most recent hemoglobin A1c ≥ 9% within the last 2 years. Age ≥ 18 years old. Type 1 or type 2 diabetes. Paneled to a Mayo Clinic or Mayo Clinic Health System practice. Able to provide informed consent. Proficient in English. Community-dwelling. Live in Southeast Minnesota (Mower, Freeborn, or Olmsted counties) or Northwest Wisconsin (Barron, Rusk, or Dunn counties). Inclusion Criteria (Paramedics): •Community Paramedics who delivered the Diabetes-REM intervention. Exclusion Criteria: Cognitive impairment precluding informed consent. Lack of conversational English skills. Resident of a long-term care facility. Enrolled in hospice. Enrolled in a care coordination or disease management program. Advanced or terminal illness.

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes-REM Program<br> | Other: Diabetes-REM Program<br>* A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress (using DDS) | The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from Not a Problem (1) to A Very Serious Problem (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Distress (using DDS) | The level of diabetes-related distress that is expressed by patient participants using the Diabetes Distress Scale (the DDS contains 17 questions, with responses ranging from Not a Problem (1) to A Very Serious Problem (6). Total scores use the sum of all responses divided by 17, with a mean item score of 3 or higher (moderate distress) indicating distress worthy of clinical attention.) | 4 months | 
| Confidence in Diabetes Self-Management (using DSMQ) | The level of confidence patient participants express in managing their diabetes using the Diabetes Self-Management Questionnaire (DSMQ) | 1 and 4 months | 
| Health-Related Quality of Life (using EQ-5D) | Patients participants' self-reported health-related quality of life using the EuroQol 5-D (also known as EQ-5D; an instrument for measuring quality of life) | 1 and 4 months | 
| Self-Reported Hypoglycemia and Hyperglycemia | Incidences of hypoglycemia (blood glucose <70 mg/dL and <54 mg/dL) and hyperglycemia (blood glucose ≥250 mg/dL) as reported by patient participants | 1 and 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community paramedicine, Diabetes mellitus, Diabetes distress