Intensive Discharge Intervention in Diabetes

Study Overview
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Brief Summary
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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.

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

Conditions
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Type II Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Other: Intensive discharge intervention


Participation Criteria
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Eligibility Criteria
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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: prescribed insulin prior to admission 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: Discharge to a location other than home or rehabilitation (or to a caregiver's home) Patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications Police custody, no telephone or homeless Previous enrolment in the study within 90 days of discharge Patient unable to communicate in either English or Spanish Participation in the Integrated Care Management Program (iCMP)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive discharge intervention<br>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. | Other: Intensive discharge intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients in the control arm of this study receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac medication adherence | Cardiac medication adherence as determined by patient self report 30 days after discharge | 30 days after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycemic control as determined by change in A1c 90 days after discharge. | 90 days after discharge | 
| Emergency department visits | Emergency department visits within 30 days of discharge. | Within 30 days after discharge | 
| Number of self-reported hypoglycemic events | Number of self-reported hypoglycemic events within 30 days of discharge. | Within 30 days of discharge | 
| 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 | 
| Cardiac medication adherence | Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge. | 90 days after discharge | 
| Hospital Readmissions | Hospital readmissions within 30 days of discharge. | Within 30 days of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication reconciliation, Coleman Transitions Coach, telemonitoring; hypoglycemic events, Transitions in care, discharge intervention, RCT, readmission rates, medication adherence, glycemic control, ED visits