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

Diabetes Clinical Trial

— COACH-DM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065050
• Other study ID #: 2012P002461
• Secondary ID: UD7HP25059
• Status: Completed
• Phase: N/A
• First received: February 14, 2014
• Last updated: May 8, 2017
• Start date: February 2012
• Est. completion date: June 2016

Study information

• Verified date: May 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• team-based care
Patients in the eDMS arm are called at least every month for their diabetes treatment.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	Data on participant HbA1c will be collected at the end of the 1 year.	1 year after date of discharge
Secondary	Blood Pressure	Blood pressure measurements will be obtained at 1 year.	1 year after discharge
Secondary	LDL Cholesterol	LDL cholesterol measured at 1 year after discharge.	1 year post-discharge
Secondary	Urine microalbumin	Urine microalbumin measured at 1 year after discharge.	1 year post-discharge
Secondary	BMI	BMI will be obtained at 1 year	1-year post-discahrge