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临床试验/NCT02065050
NCT02065050已完成不适用

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
220
试验地点
2
主要终点
Hemoglobin A1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective surgery
  • HbA1c >=8% within 3 months before surgery
  • Age > 18 years

排除标准

  • undergoing same day surgery without post-operative admission
  • HbA1c < 8%
  • individuals undergoing bariatric surgery
  • individuals with metastatic cancer or short life expectancy

结局指标

主要结局

Hemoglobin A1c

时间窗: 1 year after date of discharge

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajesh K. Garg

Associate Physician

Brigham and Women's Hospital

研究点 (2)

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