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Mobile Diabetes Education Teams in Primary Care

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ClinicalTrials.gov Identifier: NCT01553266
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : April 18, 2017
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Trillium Health Centre
Information provided by (Responsible Party):
Enza Gucciardi, Ryerson University

Brief Summary:

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 or disease Intervention/treatment
Diabetes Mellitus Behavioral: Mobile Diabetes Education Teams intervention

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Mobile Diabetes Education Teams in Primary Care
Actual Study Start Date : March 1, 2012
Primary Completion Date : March 12, 2014
Study Completion Date : April 12, 2017

Group/Cohort Intervention/treatment
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
Control group
Patients who have not received the MDET intervention.



Primary Outcome Measures :
  1. 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 ]
    Change in patients' results for HbA1c from 12 months prior to intervention up to 12 months during the intervention.


Secondary Outcome Measures :
  1. 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 ]
    Change in patients' results for low-density lipoprotein (LDL-C) from 12 months prior to intervention up to 12 months during the intervention.

  2. 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 ]
    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.

  3. 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 ]
    Change in patients' results for blood pressure from 12 months prior to intervention up to 12 months during the intervention.

  4. 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 ]
    Change in proportion of primary care physicians testing for patients' HbA1c from 12 months prior to intervention up to 12 months during the intervention.

  5. 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 ]
    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.

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    Change in proportion of primary care physicians performing foot exams from 12 months prior to intervention up to 12 months during the intervention.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. 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 ]
    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.

  12. Patient attendance at scheduled MDET visits [ Time Frame: At 12 months of intervention ]
    Number of MDET appointments planned for each patient compared to the number of MDET visits attended.

  13. Collaborative Practice Assessment Tool scores of PCPs and MDET educators in intervention [ Time Frame: At 12 months of intervention ]
    Collaborative Practice Assessment Tool scores of PCPs and MDET educators at 12 months of the intervention, to assess interprofessional collaboration between PCPs and educators.

  14. Patients' interview responses regarding intervention effectiveness [ Time Frame: At 12 months of intervention ]
    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.

  15. PCPs' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: At 12 months of intervention ]
    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.

  16. MDET educators' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: At 12 months of intervention ]
    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.

  17. MDET educators' reflective journal responses regarding interprofessional collaboration in, and the implementation of, the intervention [ Time Frame: Up to 2 years ]
    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.

  18. MDET educators' quarterly debriefing session group discussions regarding intervention issues [ Time Frame: Up to 2 years ]
    MDET educators' group discussions during MDET debriefing sessions, held quarterly, regarding any issues with the implementation of the intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those living with diabetes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01553266


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

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 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: December 2013

Keywords provided by Enza Gucciardi, 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