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NCT Number: NCT02065050

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

team-based care

Other

Patients in the eDMS arm are called at least every month for their diabetes treatment.

Primary outcomes

  1. 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

  1. Blood Pressure

    Time frame: 1 year after discharge

    Blood pressure measurements will be obtained at 1 year.

  2. LDL Cholesterol

    Time frame: 1 year post-discharge

    LDL cholesterol measured at 1 year after discharge.

  3. Urine microalbumin

    Time frame: 1 year post-discharge

    Urine microalbumin measured at 1 year after discharge.

  4. BMI

    Time frame: 1-year post-discahrge

    BMI will be obtained at 1 year

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Acronym: COACH-DM

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2014
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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