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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385758
• Other study ID #: 20-001011
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: October 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 10, 2022
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• Diabetes-REM Program
A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials