IDID: Intensive Discharge Intervention in Diabetes

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02122926
Collaborator
Sanofi (Industry)
180
1
2
19
9.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Intensive discharge intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Cardiac medication adherence [30 days after discharge]

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

Secondary Outcome Measures

  1. Glycemic control [90 days after discharge]

    Glycemic control as determined by change in A1c 90 days after discharge.

  2. Emergency department visits [Within 30 days after discharge]

    Emergency department visits within 30 days of discharge.

  3. Number of self-reported hypoglycemic events [Within 30 days of discharge]

    Number of self-reported hypoglycemic events within 30 days of discharge.

  4. 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

  5. Cardiac medication adherence [90 days after discharge]

    Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge.

  6. Hospital Readmissions [Within 30 days of discharge]

    Hospital readmissions within 30 days of discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • Sanofi

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jeffrey L. Schnipper, MD.,MPH., Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02122926
Other Study ID Numbers:
  • 2010A056508
  • 2011-P-000217
First Posted:
Apr 25, 2014
Last Update Posted:
Apr 25, 2014
Last Verified:
Apr 1, 2014

Study Results

No Results Posted as of Apr 25, 2014