Diabetes Mellitus Clinical Trial
Official title:
Mobile Diabetes Education Teams in Primary Care
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).
The proposed research is the first evaluation of the implementation of Mobile Diabetes
Education Teams (MDETs) in Canada. This intervention will support primary care providers
(PCPs) by offering a diabetes education team (one registered nurse [RN] and one registered
dietitian [RD]) one to four times a month, based on patient volume, at various primary care
sites to assist in and share the care and management of patients with diabetes. This
intervention is in collaboration with the Mississauga Halton Local Health Integration
Network (MH LHIN) and will be hosted by Trillium Diabetes Management Centre and Halton
Diabetes Program. Each hosting site received permanent operational funding for half a
diabetes education team (salary support) from the Ontario Ministry of Health and Long-term
Care (MHLTC) under the new Ontario Diabetes Strategy.
The rationale for incorporating MDETs in primary care was guided by the extensive literature
on the underuse and low referral to diabetes education programs (DEPs), where diabetes
self-management education is primarily offered. Low utilization is due to low PCP referral
rates to these services, as well as numerous systematic and operational barriers for both
PCPs and patients. Consequently, the majority of Canadians are receiving diabetes care
solely from their PCPs, who have expressed barriers to caring for diabetes patients and are
providing sub-optimal care as they are not consistently adhering to clinical practice
guidelines. As a result, MHLTC is investing millions of dollars in expanding and aligning
current programs to increase access to team-based care.
The objective of this research is to evaluate a structural redesign in how the investigators
deliver diabetes care and self-management education using a collaborative approach between
PCPs and DEPs guided by the Chronic Care Model as a conceptual framework. The purpose of
this research is twofold: 1) to evaluate the effects of MDET intervention on: (i) patient
clinical outcomes; (ii) quality of care patients receive from PCPs; (iii) PCPs' referral to
and their patients' utilization of DEPs; and 2) to assess the implementation processes of
the MDET intervention and the degree of collaboration and team functioning between PCPs and
the MDET members across primary care sites. A mixed-methods approach is proposed over a
three year period.
Patients will be referred to the MDET by PCPs. The MDET will meet with patients for two
hours (one hour with the RN and one hour with the RD) to assess the level of diabetes
knowledge, diabetes self-care and lifestyle habits; this data will be used to develop
patient treatment priorities and action care plans. Three 30 minute follow-up visits with
the MDET will be carried out over a one-year period for all patients where patient action
plans are reviewed, discussed and potentially revised. A communication tool has been
developed to better facilitate communication of patient information between PCPs and MDETs.
Case conferences will be conducted when major changes are to be made to the patient's
treatment plan after a patient's visit. Accordingly, PCPs and educators are collaboratively
managing patient care.
A cluster-randomized trial stepped wedge design will be used to ensure all sites will
eventually receive the intervention, while still facilitating the comparison of change
within individuals and between study groups across time points that is attributed to the
intervention. The inclusion criteria for reviewing patient medical records are patients who
are over 18 years of age, have type 2 diabetes, and have an HbA1c of greater than 8%. Twenty
unique patient chart extractions will be performed at 0, 6, 12, 18, 24 months from 12
primary care sites to collect patient care processes and patient clinical outcome data (for
a total of 1,200 patient charts). Characteristics of interprofessional collaboration between
PCPs and the MDET will be assessed at each practice site at the end of one year. To assess
the implementation of the MDET across sites, qualitative process data, such as in-depth
interviews with patients, PCPs and the MDETs, and MDETs' field notes and debriefing sessions
will be analyzed.
MDETs will strengthen and formalize links between primary care providers and diabetes
education programs within the community, increase patient access to diabetes self-management
education and support, and potentially improve patient experience and clinical outcomes
through enhanced coordination and integration of care. This study is timely and relevant as
DEPs and local PCPs are starting to integrate services across Canada; thus, our research
will provide the evidence necessary to inform practice of such a model. If results are
promising, this model can be extended to direct how those with impaired glucose tolerance
and gestational diabetes/post-gestational diabetes; and as a result, diabetes prevention,
management and care are delivered, and can greatly reduce the burden of diabetes in Canada.
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