Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With Diabetes Mellitus (DM)

Study Overview
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Brief Summary
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This study is being performed to evaluate whether a comprehensive discharge planning and close follow up for one year can improve clinical outcomes and cut costs of care for patients with poorly controlled diabetes. The study takes a high risk approach and is focused on patients admitted to hospital for elective surgery with HbA1c >8%. Secondary goals include improving teamwork and communication for clinicians within the team and teaching nurse practitioners and physicians-in-training how to work effectively within interdisciplinary teams. Investigators anticipate that the results of this project may lead to the following benefits: 1) improved health outcomes for surgical patients with diabetes, 2) improved strategies for better communication within interdisciplinary health care teams, and 3) decreased health care costs.

Detailed Description
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All patients who are planned for elective surgery at the hospital are seen in the pre-operative center a few days before admission. The diabetes management team becomes involved in care of patients with HbA1c >8.0% at this time. Once the patients are admitted to the hospital, the diabetes management team continues to follow them until they are ready for discharge. At the point of discharge, patients are randomized to one of two arms- the usual care group and the expanded diabetes management service (eDMS). The eDMS group is followed closely for 1 year after discharge by the investigators to make sure they receive appropriate care for their diabetes. Aims of this study are: To evaluate whether patients that receive the eDMS have lower re-hospitalization rates at 1 month compared to patients who receive the traditional (current) DMS. Investigators hypothesize that the eDMS program will have lower re-hospitalization rates at 1 month. To evaluate whether patients that receive the eDMS have lower HbA1c levels at 1 year compared with patients who receive the traditional DMS. Investigators hypothesize that patients in the eDMS program will have lower HbA1c levels and improved diabetes-related health outcomes after 1 year in the program.

Official Title
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Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With DM: COACH-DM

Conditions
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Diabetes

Intervention / Treatment
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* Other: team-based care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective surgery HbA1c >=8% within 3 months before surgery Age > 18 years Exclusion Criteria: undergoing same day surgery without post-operative admission HbA1c < 8% individuals undergoing bariatric surgery individuals with metastatic cancer or short life expectancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Individuals in the usual care arm will not receive frequent contact by the study team. Individuals will be seen by a study team clinician 1 year after discharge to review diabetes management and obtain pertinent study related data. | |
| Experimental: Continued care<br>team-based care: Individuals in the continued care arm will be frequently contacted by the study team (consisting of endocrinologists, nurse practitioners, and health coaches) over the course of one year post-discharge. The team will monitor blood sugars and other health data, altering management as needed. | Other: team-based care<br>* Patients in the eDMS arm are called at least every month for their diabetes treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Data on participant HbA1c will be collected at the end of the 1 year. | 1 year after date of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Blood pressure measurements will be obtained at 1 year. | 1 year after discharge | 
| LDL Cholesterol | LDL cholesterol measured at 1 year after discharge. | 1 year post-discharge | 
| Urine microalbumin | Urine microalbumin measured at 1 year after discharge. | 1 year post-discharge | 
| BMI | BMI will be obtained at 1 year | 1-year post-discahrge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, Team approach