Bridging the Gap by Transitional Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Other: Pharmacist Counseling

• Registration Number: NCT01330121
• Lead Sponsor: Cook County Health

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist Counseling	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

Primary Outcome Measures

Name	Time	Method
Adherence with discharge diabetes medications up to 120 days following pharmacist counseling during hospital stay about diabetes self management	up to 120 days	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

Name	Time	Method
Change in lipids after 90 days	up to 90 days	Lipid measurements in mg/dL
Change in BP after 90 days	up to 90 days	BP in mm/Hg
Change in A1c after 90 days	up to 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

Trial Locations

Locations (1)

John H. Stroger Jr. Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States