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

Mass General Brigham

Status: Completed

Conditions: Diabetes

Treatments: Other: team-based care

Study type: Interventional

Funder types: Other

Identifiers

NCT02065050

2012P002461

UD7HP25059 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Individuals in the usual care arm will not receive frequent contact by the study team. Individuals will be seen by a study team clinician 1 year after discharge to review diabetes management and obtain pertinent study related data.

Continued care

Experimental group

Description:

team-based care: Individuals in the continued care arm will be frequently contacted by the study team (consisting of endocrinologists, nurse practitioners, and health coaches) over the course of one year post-discharge. The team will monitor blood sugars and other health data, altering management as needed.

Treatment:

Other: team-based care