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Clinical Trials/NCT02065050
NCT02065050
Completed
N/A

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

Brigham and Women's Hospital1 site in 1 country220 target enrollmentFebruary 2012
ConditionsDiabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Brigham and Women's Hospital
Enrollment
220
Locations
1
Primary Endpoint
Hemoglobin A1c
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
June 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rajesh K. Garg

Associate Physician

Brigham and Women's Hospital

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

Outcomes

Primary Outcomes

Hemoglobin A1c

Time Frame: 1 year after date of discharge

Data on participant HbA1c will be collected at the end of the 1 year.

Secondary Outcomes

  • Blood Pressure(1 year after discharge)
  • LDL Cholesterol(1 year post-discharge)
  • Urine microalbumin(1 year post-discharge)
  • BMI(1-year post-discahrge)

Study Sites (1)

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