Mobile Diabetes Education Teams in Primary Care

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Trillium Health Centre
Information provided by (Responsible Party):
Enza Gucciardi, Ryerson University
ClinicalTrials.gov Identifier:
NCT01553266
First received: February 29, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's effectiveness in improving patient clinical and care process outcomes.

The study's hypotheses are that the MDET intervention results in the following outcomes:

  • Improvement in patient clinical outcomes;
  • An increase in the proportion of primary care physicians (PCPs) performing patient care processes according to clinical practice guidelines;
  • An increase in the proportion of referrals to, and patients' utilization of, diabetes education programs (DEPs).

Condition Intervention
Diabetes Mellitus
Behavioral: Mobile Diabetes Education Teams intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Mobile Diabetes Education Teams in Primary Care

Resource links provided by NLM:


Further study details as provided by Ryerson University:

Primary Outcome Measures:
  • Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in patients' results for HbA1c from 12 months prior to intervention up to 12 months during the intervention.


Secondary Outcome Measures:
  • Change from 12 months prior to intervention in low-density lipoprotein (LDL-C) up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in patients' results for low-density lipoprotein (LDL-C) from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in total cholesterol-high density lipoprotein ratio (TC-HDL ratio) up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in patients' results for total cholesterol-high density lipoprotein ratio (TC-HDL ratio) from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in blood pressure up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in patients' results for blood pressure from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in testing for HbA1c up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians testing for patients' HbA1c from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in blood pressure testing up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians testing for patients' blood pressure from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in lipid profile testing up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians testing for patients' lipid profile from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in nephropathy screening up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians screening patients for nephropathy (ACR and eGFR) from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in foot exams up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians performing foot exams from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in dilated retinal exam referrals up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians referring patients to dilated retinal exams from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in flu vaccine provision or recommendation up to 12 months during the intervention [ Time Frame: At 12 months prior to intervention; up to 12 months during the intervention ] [ Designated as safety issue: No ]
    Change in proportion of primary care physicians providing for, or recommending, the flu vaccine to patients from 12 months prior to intervention up to 12 months during the intervention.

  • Change from 12 months prior to intervention in Diabetes Education Program referrals at 12 months of intervention [ Time Frame: 12 months prior to intervention to 12 months of the intervention ] [ Designated as safety issue: No ]
    Change in primary care physicians' referrals to, and patients' utilization of, diabetes education programs from 12 months prior to the intervention at 12 months of the intervention.

  • Patient attendance at scheduled MDET visits [ Time Frame: At 12 months of intervention ] [ Designated as safety issue: No ]
    Number of MDET appointments planned for each patient compared to the number of MDET visits attended.

  • Collaborative Practice Assessment Tool scores of PCPs and MDET educators in intervention [ Time Frame: At 12 months of intervention ] [ Designated as safety issue: No ]
    Collaborative Practice Assessment Tool scores of PCPs and MDET educators at 12 months of the intervention, to assess interprofessional collaboration between PCPs and educators.

  • Patients' interview responses regarding intervention effectiveness [ Time Frame: At 12 months of intervention ] [ Designated as safety issue: No ]
    In-depth interview responses of 20 randomly-selected patients at 12 months of the intervention, regarding the usefulness of the intervention in better understanding their condition, diabetes self-management strategies, and convenience and quality of delivery.

  • PCPs' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: At 12 months of intervention ] [ Designated as safety issue: No ]
    In-depth interview responses of 16 randomly-selected PCPs at 12 months of the intervention, regarding their experiences with the intervention, their collaboration and teamwork, barriers and facilitators to implementation, and suggestions to improve the intervention.

  • MDET educators' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: At 12 months of intervention ] [ Designated as safety issue: No ]
    In-depth interview responses of 16 randomly-selected educators at 12 months of the intervention, regarding their experiences with the intervention, their collaboration and teamwork, barriers and facilitators to implementation, and suggestions to improve the intervention.

  • MDET educators' reflective journal responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    MDET educators' monthly field notes in their reflective journals regarding their experiences and reflections of those experiences with the implementation of, and interprofessional collaboration in, the intervention.

  • MDET educators' quarterly debriefing session group discussions regarding intervention issues [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    MDET educators' group discussions during MDET debriefing sessions, held quarterly, regarding any issues with the implementation of the intervention.


Estimated Enrollment: 1200
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDET intervention Behavioral: Mobile Diabetes Education Teams intervention
A MDET (one Registered Nurse and Registered Dietician) supports primary care physicians by providing diabetes management education to the PCPs' patients onsite, one to four times a month based on patient volume.
Other Name: MDET
No Intervention: Control group
Patients who have not received the MDET intervention.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has Diabetes Mellitus, Type 2;
  • Is 18 years of age or older;
  • Has an HbA1c of > 8%.

Exclusion Criteria:

  • Has type of diabetes that requires intense and specialized treatment, such as Type 1 diabetes, gestational diabetes, or patients on a multiple, daily insulin regime.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553266

Sponsors and Collaborators
Ryerson University
Canadian Institutes of Health Research (CIHR)
Trillium Health Centre
Investigators
Principal Investigator: Enza Gucciardi, PhD Ryerson University
  More Information

No publications provided by Ryerson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Enza Gucciardi, Assistant Professor, Ryerson University
ClinicalTrials.gov Identifier: NCT01553266     History of Changes
Other Study ID Numbers: REB 2010-282, 247888
Study First Received: February 29, 2012
Last Updated: December 4, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Ryerson University:
Diabetes Mellitus
diabetes care
diabetes self-management education
primary care physicians
interprofessional collaboration
diabetes education programs
qualitative
quantitative
implementation
evaluation
health services
coordinated care
integrated care
patient care processes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014