Clinical trial NCT02065050: Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With Diabetes Mellitus (DM)
Official title: Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With DM: COACH-DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes mellitus
Team approach
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. 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.
2. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year after date of discharge
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1 year after discharge
measure: LDL Cholesterol
timeFrame: 1 year post-discharge
measure: Urine microalbumin
timeFrame: 1 year post-discharge
measure: BMI
timeFrame: 1-year post-discahrge
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Rajesh K. Garg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garg R, Hurwitz S, Rein R, Schuman B, Underwood P, Bhandari S. Effect of follow-up by a hospital diabetes care team on diabetes control at one year after discharge from the hospital. Diabetes Res Clin Pract. 2017 Nov;133:78-84. doi: 10.1016/j.diabres.2017.08.014. Epub 2017 Aug 24.