NCT02065050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

February 14, 2014

Last Update Submit

May 8, 2017

Conditions

Diabetes

Keywords

Diabetes mellitusTeam approach

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    Data on participant HbA1c will be collected at the end of the 1 year.

    1 year after date of discharge

Secondary Outcomes (4)

  • Blood Pressure

    1 year after discharge

  • LDL Cholesterol

    1 year post-discharge

  • Urine microalbumin

    1 year post-discharge

  • BMI

    1-year post-discahrge

Study Arms (2)

Usual Care

NO INTERVENTION

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

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

Interventions

team-based careOTHER

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

Continued care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective surgery
  • HbA1c \>=8% within 3 months before surgery
  • Age \> 18 years

You may not qualify if:

  • undergoing same day surgery without post-operative admission
  • HbA1c \< 8%
  • individuals undergoing bariatric surgery
  • individuals with metastatic cancer or short life expectancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Garg R, Hurwitz S, Rein R, Schuman B, Underwood P, Bhandari S. Effect of follow-up by a hospital diabetes care team on diabetes control at one year after discharge from the hospital. Diabetes Res Clin Pract. 2017 Nov;133:78-84. doi: 10.1016/j.diabres.2017.08.014. Epub 2017 Aug 24.

    PMID: 28898714DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Rajesh K. Garg, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

February 1, 2012

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

This study will not produce data that can be shared

Locations

US(1)