Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 8:35 AM
Study NCT ID:
NCT02065050
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With Diabetes Mellitus (DM)
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Comprehensive Intervention to Evaluate Outcomes AND Cost in Hospitalized Surgical Patients With DM: COACH-DM
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COACH-DM
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UD7HP25059 | OTHER_GRANT | HRSA | View |