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

October 6, 2022 updated by: Rozalina G. McCoy, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diabetes-REM Program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress (using DDS)
Time Frame: 1 month
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)
Time Frame: 4 months
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)
Time Frame: 1 and 4 months
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)
Time Frame: 1 and 4 months
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
Time Frame: 1 and 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Rozalina McCoy, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2020

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

February 10, 2022

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 9, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 7, 2022

Last Update Submitted That Met QC Criteria

October 6, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-001011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe