Back to resultsIntensive Discharge Intervention in Diabetes (IDID)
Primary Purpose
Type II Diabetes, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive discharge intervention
Sponsored by
About this trial
This is an interventional health services research trial for Type II Diabetes focused on measuring Transitions in care, discharge intervention, RCT, readmission rates, medication adherence, glycemic control, ED visits, medication reconciliation, Coleman Transitions Coach, telemonitoring; hypoglycemic events
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:
- 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)
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensive discharge intervention
Usual Care
Arm Description
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.
Patients in the control arm of this study receive usual care.
Outcomes
Primary Outcome Measures
Cardiac medication adherence
Cardiac medication adherence as determined by patient self report 30 days after discharge
Secondary Outcome Measures
Glycemic control
Glycemic control as determined by change in A1c 90 days after discharge.
Emergency department visits
Emergency department visits within 30 days of discharge.
Number of self-reported hypoglycemic events
Number of self-reported hypoglycemic events 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
Cardiac medication adherence
Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge.
Hospital Readmissions
Hospital readmissions within 30 days of discharge.
Full Information
NCT ID
NCT02122926
First Posted
January 25, 2013
Last Updated
April 24, 2014
Sponsor
Brigham and Women's Hospital
Collaborators
Sanofi
1. Study Identification
Unique Protocol Identification Number
NCT02122926
Brief Title
Intensive Discharge Intervention in Diabetes
Acronym
IDID
Official Title
Effects of an Intensive Discharge Intervention on Medication Adherence, Glycemic Control, and Readmission Rates in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Sanofi
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive discharge intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients in the control arm of this study receive usual care.
Intervention Type
Other
Intervention Name(s)
Intensive discharge intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac medication adherence
Description
Cardiac medication adherence as determined by patient self report 30 days after discharge
Time Frame
30 days after discharge
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Glycemic control as determined by change in A1c 90 days after discharge.
Time Frame
90 days after discharge
Title
Emergency department visits
Description
Emergency department visits within 30 days of discharge.
Time Frame
Within 30 days after discharge
Title
Number of self-reported hypoglycemic events
Description
Number of self-reported hypoglycemic events within 30 days of discharge.
Time Frame
Within 30 days of discharge
Title
Number of patient-days with hypoglycemia
Description
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
Time Frame
Within 30 days of discharge
Title
Cardiac medication adherence
Description
Cardiac medication adherence as determined by pharmacy refill rates for 90 days after discharge.
Time Frame
90 days after discharge
Title
Hospital Readmissions
Description
Hospital readmissions within 30 days of discharge.
Time Frame
Within 30 days of discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Schnipper, MD, MPH, FHM
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intensive Discharge Intervention in Diabetes
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