Bridging the Gap by Transitional Care

Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Other: Pharmacist Counseling

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: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Jr. Hospital of Cook County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in BP after 90 days	BP in mm/Hg	up to 90 days
Change in lipids after 90 days	Lipid measurements in mg/dL	up to 90 days

Collaborators and Investigators

• Sponsor: Cook County Health
• Investigators: Principal Investigator: Leon Fogelfeld, M.D., John H. Stroger Hospital of Cook County, Division of Endocrinology; Principal Investigator: Mansi Shah, PharmD, John H. Stroger Hospital of Cook County, Department of Pharmacy; Principal Investigator: CaTanya Norwood, R.PH, John H. Stroger Hospital of Cook County, Department of Pharmacy

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (Estimated): April 6, 2011

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: 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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB #10-165