Clinical trial NCT01553266: Mobile Diabetes Education Teams in Primary Care
Official title: Mobile Diabetes Education Teams in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: 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
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Trillium Health Centre
First posted: 2012-03-14
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those living with diabetes

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).

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
Secondary outcomes:
measure: Change from 12 months prior to intervention in low-density lipoprotein (LDL-C) up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in total cholesterol-high density lipoprotein ratio (TC-HDL ratio) up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in blood pressure up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in testing for HbA1c up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in blood pressure testing up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in lipid profile testing up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in nephropathy screening up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in foot exams up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in dilated retinal exam referrals up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in flu vaccine provision or recommendation up to 12 months during the intervention
timeFrame: At 12 months prior to intervention; up to 12 months during the intervention
measure: Change from 12 months prior to intervention in Diabetes Education Program referrals at 12 months of intervention
timeFrame: 12 months prior to intervention to 12 months of the intervention
measure: Patient attendance at scheduled MDET visits
timeFrame: At 12 months of intervention
measure: Collaborative Practice Assessment Tool scores of PCPs and MDET educators in intervention
timeFrame: At 12 months of intervention
measure: Patients' interview responses regarding intervention effectiveness
timeFrame: At 12 months of intervention
measure: PCPs' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
timeFrame: At 12 months of intervention
measure: MDET educators' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
timeFrame: At 12 months of intervention
measure: MDET educators' reflective journal responses regarding interprofessional collaboration in, and the implementation of, the intervention
timeFrame: Up to 2 years
measure: MDET educators' quarterly debriefing session group discussions regarding intervention issues
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Toronto Metropolitan University
name: Enza Gucciardi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gucciardi E, Fortugno M, Horodezny S, Lou W, Sidani S, Espin S, Webster F, Shah BR. Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial. Trials. 2012 Sep 13;13:165. doi: 10.1186/1745-6215-13-165.