Cardiovascular Disease, Type II Diabetes
Conditions
Keywords
Transitions in care, discharge intervention, RCT, readmission rates, medication adherence, glycemic control, ED visits, medication reconciliation, Coleman Transitions Coach, telemonitoring; hypoglycemic events
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.
Interventions
OTHERIntensive discharge intervention
The intervention is a multi-modal program consisting of the following: 1. Inpatient protocol for adjusting the discharge diabetes regimen; 2. Nurse practitioner discharge advocate to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling; 3. Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education); 4. Visiting nurse intervention after discharge; 5. Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge; 6. Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and 7. Follow-up with PCP or endocrinologist within 1 week of discharge.
Sponsors
Sanofi
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac medication adherence | 30 days after discharge | Cardiac medication adherence as determined by patient self report 30 days after discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Glycemic control | 90 days after discharge | Glycemic control as determined by change in A1c 90 days after 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. |
| 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 |
Countries
United States
Outcome results
None listed