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

Tracking Information

First Received Date ^ICMJE

April 5, 2011

Last Updated Date

April 5, 2011

Start Date ^ICMJE

September 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bridging the Gap by Transitional Care

Official Title ^ICMJE

Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

Brief Summary

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

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Diabetes Mellitus Type 2

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Other: Pharmacist Counseling
No Intervention: Standard therapy
Standard therapy: Nurses distribute a education pamphlet on diabetes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

130

Completion Date

April 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01330121

Other Study ID Numbers ^ICMJE

IRB #10-165

Has Data Monitoring Committee

Yes

Responsible Party

Leon Fogelfeld, M.D., John H. Stroger Hospital of Cook County, Division of Endocrinology

Study Sponsor ^ICMJE

John H. Stroger Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Leon Fogelfeld, M.D.

John H. Stroger Hospital of Cook County, Division of Endocrinology

Information Provided By

John H. Stroger Hospital

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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