Bridging the Gap by Transitional Care

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330121
• Other study ID #: IRB #10-165
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: July 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	John H. Stroger Jr. Hospital of Cook County	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Cook County Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management	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	up to 120 days
Secondary	Change in A1c after 90 days	A1c measure as % 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	up to 90 days
Secondary	Change in BP after 90 days	BP in mm/Hg	up to 90 days
Secondary	Change in lipids after 90 days	Lipid measurements in mg/dL	up to 90 days