Bridging the Gap by Transitional Care

Study Overview
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Brief Summary
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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
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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

Official Title
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Pharmacist Discharge Counseling: Bridging the Gap by Transitional Care

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Other: Pharmacist Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacist Counseling<br>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<br>* 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<br>|
| No Intervention: Standard therapy<br>Standard therapy: Nurses distribute a education pamphlet on diabetes | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence with discharge diabetes medications, Diabeted mellitus type 2 greater than one year, Patient with provider and prescriptions filled within CCHS