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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


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
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