Intensive Discharge Intervention in Diabetes

NCT02122926 | Completed

• 2 other identifiers: 2010A0565082011-P-000217
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Type II Diabetes; Cardiovascular Disease

Keywords

Transitions in care; discharge intervention; RCT; readmission rates; medication adherence; glycemic control; ED visits; medication reconciliation; Coleman Transitions Coach; telemonitoring; hypoglycemic events

Outcome Measures

Primary Outcomes (1)

• Cardiac medication adherence

  Cardiac medication adherence as determined by patient self report 30 days after discharge

  30 days after discharge

Secondary Outcomes (6)

• Glycemic control

  90 days after discharge

• Emergency department visits

  Within 30 days after discharge

• Number of self-reported hypoglycemic events

  Within 30 days of discharge

• Number of patient-days with hypoglycemia

  Within 30 days of discharge

• Cardiac medication adherence

  90 days after discharge

Study Arms (2)

Intensive discharge intervention

EXPERIMENTAL

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.

Other: Intensive discharge intervention

Usual Care

NO INTERVENTION

Patients in the control arm of this study receive usual care.

Interventions

Intensive discharge intervention OTHER

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.

Intensive discharge intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Sanofi: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases; Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeffrey L Schnipper, MD, MPH, FHM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: April 25, 2014
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

US (1)