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Bridging the Gap by Transitional Care

This study has been completed.
Sponsor:
Information provided by:
John H. Stroger Hospital
ClinicalTrials.gov Identifier:
NCT01330121
First received: April 5, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

The purpose of the study is to evaluate patient adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management


Condition Intervention
Diabetes Mellitus Type 2
 Other: Pharmacist Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by John H. Stroger Hospital:

Primary Outcome Measures:
  • Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management [ Time Frame: up to 120 days ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the difference in rate of adherence with medications Adherence will be assessed at 30, 60, 90, and 120 days following discharge An average of the total adherence rate 120 days following discharge will be calculated as the primary outcome measure


Secondary Outcome Measures:
  • Changes in HbA1c, blood pressure, and lipid panel 90 days following pharmacist counseling [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
    • To evaluate changes in glycosylated hemoglobin (HbA1c), blood pressure (BP), and lipid panel 90 days following pharmacist counseling
    • To demonstrate an improvement in health literacy following pharmacist counseling on diabetes
    • To evaluate patient compliance with follow up appointments up to 90 days following pharmacist counseling


Enrollment: 130
Study Start Date: September 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pharmacist Counseling

Pharmacist Counseling includes but is not limited to:

Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity

 Other: Pharmacist Counseling

Pharmacist Counseling includes but is not limited to:

Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity
No Intervention: Standard therapy
Standard therapy: Nurses distribute a education pamphlet on diabetes

Detailed Description:

It is a prospective, randomized, controlled Study. Patients randomized in a 1:1 ratio to pharmacist counseling or standard of therapy prior to discharge.

Standard therapy: Nurses distribute a education pamphlet on diabetes.

Pharmacist Counseling includes but is not limited to:

  • Reviewing and explaining their medications (dosing, side effects, route)
  • Reviewing symptoms and complications of hyper and hypoglycemia
  • Defining glycemic & non-glycemic goal levels
  • Explaining the importance of compliance with medications & appointments
  • Educating on the basics of nutrition and physical activity
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females
  • 18 to 85 years of age
  • Historical diagnosis of type 2 diabetes mellitus greater than one year
  • HbA1c concentration ≥ 8%
  • Discharged from general medicine unit of John H. Stroger Jr, Hospital of Cook County
  • Patient with provider and prescriptions filled within CCHS

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnancy
  • Major illness or debility, that prohibits the subject from participating in the study
  • History of any hemoglobinopathy that may affect determination of HbA1c
  • Non-English speaking patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330121

Locations
United States, Illinois
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
John H. Stroger Hospital
Investigators
Principal Investigator: Leon Fogelfeld, M.D. John H. Stroger Hospital of Cook County, Division of Endocrinology
  More Information

No publications provided

Responsible Party: Leon Fogelfeld, M.D., John H. Stroger Hospital of Cook County, Division of Endocrinology
ClinicalTrials.gov Identifier: NCT01330121     History of Changes
Other Study ID Numbers: IRB #10-165
Study First Received: April 5, 2011
Last Updated: April 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by John H. Stroger Hospital:
Adherence with discharge diabetes medications
Diabeted mellitus type 2 greater than one year
Patient with provider and prescriptions filled within CCHS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013