Intensive Discharge Intervention in Diabetes

NCT ID: NCT02122926

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Intensive 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.

Group Type: EXPERIMENTAL

Intensive discharge intervention

Intervention Type: 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.

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intensive 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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey L. Schnipper, MD.,MPH.

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey L Schnipper, MD, MPH, FHM

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011-P-000217

Identifier Type: OTHER

Identifier Source: secondary_id

2010A056508

Identifier Type: -

Identifier Source: org_study_id