Cardiovascular Disease Clinical Trial
— IDIDOfficial title:
Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
Verified date | April 2014 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac medication adherence | Cardiac medication adherence as determined by patient self report 30 days after discharge | 30 days after discharge | No |
Secondary | Glycemic control | Glycemic control as determined by change in A1c 90 days after discharge. | 90 days after discharge | No |
Secondary | Emergency department visits | Emergency department visits within 30 days of discharge. | Within 30 days after discharge | No |
Secondary | Number of self-reported hypoglycemic events | Number of self-reported hypoglycemic events within 30 days of discharge. | Within 30 days of discharge | Yes |
Secondary | Number of patient-days with hypoglycemia | 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 | Within 30 days of discharge | Yes |
Secondary | Cardiac medication adherence | Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge. | 90 days after discharge | No |
Secondary | Hospital Readmissions | Hospital readmissions within 30 days of discharge. | Within 30 days of discharge | No |
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