Intensive Discharge Intervention in Diabetes

Not Applicable

Completed

• Conditions: Cardiovascular Disease; Type II Diabetes

• Registration Number: NCT02122926
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-01-25
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-24
• Last Update Submitted: 2014-04-24
• Study First Posted: 2014-04-25
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Adult inpatients at BWH on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study

• Type 2 diabetes

• Active cardiovascular disease

• Likely to be discharged home, and one of the following:

  1. prescribed insulin prior to admission
  2. prescribed two oral agents and with an A1c > 8.0 within 30 days of admission. - Practices that have already agreed to participate in this study for all their eligible patients.

Exclusion Criteria

1. Discharge to a location other than home or rehabilitation (or to a caregiver's home)
2. Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications
3. Police custody, no telephone or homeless
4. Previous enrolment in the study within 90 days of discharge
5. Patient unable to communicate in either English or Spanish
6. Participation in the Integrated Care Management Program (iCMP)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cardiac medication adherence	30 days after discharge	Cardiac medication adherence as determined by patient self report 30 days after discharge

Secondary Outcome Measures

Name	Time	Method
Glycemic control	90 days after discharge	Glycemic control as determined by change in A1c 90 days after discharge.
Emergency department visits	Within 30 days after discharge	Emergency department visits within 30 days of discharge.
Number of self-reported hypoglycemic events	Within 30 days of discharge	Number of self-reported hypoglycemic events within 30 days of discharge.
Number of patient-days with hypoglycemia	Within 30 days of discharge	Number of patient-days with hypoglycemia (point-of-care glucose less than 70 mg/dL) or with severe hypoglycemia (less than 40 mg/dL) within 30 days of discharge
Cardiac medication adherence	90 days after discharge	Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge.
Hospital Readmissions	Within 30 days of discharge	Hospital readmissions within 30 days of discharge.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States