Intensive Discharge Intervention in Diabetes (IDID)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Type II Diabetes
• Intervention / Treatment: Other: Intensive discharge intervention

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Usual Care; Patients in the control arm of this study receive usual care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Sanofi
• Investigators: Principal Investigator: Jeffrey L Schnipper, MD, MPH, FHM, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: RCT; medication adherence; glycemic control; Transitions in care; discharge intervention; readmission rates; ED visits; medication reconciliation; Coleman Transitions Coach; telemonitoring; hypoglycemic events
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2010A056508; 2011-P-000217 (Other Identifier: Partners Human Research Committee)