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OpenTrials
Completed

NCT Number: NCT02122926

Intensive Discharge Intervention in 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.

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Key information

Conditions

Type II Diabetes Behavior Cardiovascular Disease Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Health Behavior Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intensive discharge intervention

Other

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 outcomes

  1. Cardiac medication adherence

    Time frame: 30 days after discharge

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

Secondary outcomes

  1. Glycemic control

    Time frame: 90 days after discharge

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

  2. Emergency department visits

    Time frame: Within 30 days after discharge

    Emergency department visits within 30 days of discharge.

  3. Number of self-reported hypoglycemic events

    Time frame: Within 30 days of discharge

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

  4. Number of patient-days with hypoglycemia

    Time frame: 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

    Time frame: 90 days after discharge

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

  6. Hospital Readmissions

    Time frame: Within 30 days of discharge

    Hospital readmissions within 30 days of discharge.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Acronym: IDID

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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