Intensive Discharge Intervention in Diabetes

Cardiovascular Disease Clinical Trial

— IDID  

Official title:

Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122926
• Other study ID #: 2010A056508
• Secondary ID: 2011-P-000217
• Status: Completed
• Phase: N/A
• First received: January 25, 2013
• Last updated: April 24, 2014
• Start date: December 2011
• Est. completion date: July 2013

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Other:
• Intensive discharge intervention
The intervention is a multi-modal program consisting of the following: Inpatient protocol for adjusting the discharge diabetes regimen; Nurse practitioner "discharge advocate" to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling; Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education); Visiting nurse intervention after discharge; Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge; Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and Follow-up with PCP or endocrinologist within 1 week of discharge.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

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