An interventional study of team-based care in Diabetes, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-10.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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:
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 220 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Other: team-based care
Patients in the eDMS arm are called at least every month for their diabetes treatment.
Hemoglobin A1c
Data on participant HbA1c will be collected at the end of the 1 year.
Time frame: 1 year after date of discharge
Blood Pressure
Blood pressure measurements will be obtained at 1 year.
Time frame: 1 year after discharge
LDL Cholesterol
LDL cholesterol measured at 1 year after discharge.
Time frame: 1 year post-discharge
Urine microalbumin
Urine microalbumin measured at 1 year after discharge.
Time frame: 1 year post-discharge
BMI
BMI will be obtained at 1 year
Time frame: 1-year post-discahrge
Plan to share: No — This study will not produce data that can be shared
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Brigham and Women's Hospital