Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Education; Drug-Related Side Effects and Adverse Reactions
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional

Summary: 
      Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400
      million people worldwide. There are a few studies evaluating ADRs in diabetics. Many patients
      experience ADRs soon after hospital discharge which can be attributed to the changes in the
      pharmacotherapy during hospitalization. Education and counseling of diabetic patients has
      been shown to improve medication adherence and clinical outcomes. Studies that included
      medical patients revealed that education can significantly reduce risk of ADRs after hospital
      discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics
      that is focused on a proper use of medications, prevention and early detection of ADRs.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that affects more than 400
      million people worldwide. Besides adapting their lifestyle, a large majority of diabetic
      patients needs pharmacotherapy to achieve adequate glycaemic control. Additional
      pharmacotherapy is usually needed for the treatment of concomitant diseases and risk factors.
      This can result in polytherapy which puts patients et risk of adverse drug reactions (ADRs).
      There are a few studies evaluating ADRs in diabetics. A prospective observation study
      reported ADRs in 11.8% of diabetic patients in tertiary care hospital. Many patients
      experience ADRs soon after hospital discharge which can be attributed to the changes in the
      pharmacotherapy during hospitalization. These ADRs can result in early readmission and
      emergency department (ED) visits. In an Italian study, ADRs were reported in 73.8% of
      patients taking oral antidiabetics drugs within one month of study enrollment. It is
      estimated that between 11-38% of ambulatory ADRs are preventable. Medication adherence plays
      an important role in the treatment of T2DM because it clearly improves glycaemic control and
      clinical outcomes and lowers medical costs. Adherence rates to DM medications vary from 31%
      to 87% in retrospective studies and 53% to 98% in prospective studies. It is affected by many
      factors such as age, race, health beliefs, medication cost, co-pays, etc. Adherence is lower
      in the case of ADRs, when medications are taken more than twice daily, with concomitant
      depression and skepticism about the importance of medication. In recent years, 30-day
      readmission rate has been emphasised as a measure of healthcare quality. Diabetic patients
      have higher readmission rate compared to patients without DM. In the study by Ostling and
      al., 30-day readmission rate for patients with DM was 26%. Many readmissions are drug-related
      and can be caused by ADRs and non-adherence. These readmissions are potentially preventable.
      It is estimated that between 40%-57.1% of readmissions caused by ADRs and all readmissions
      caused by non-adherence are preventable. Education and counseling of diabetic patients has
      been shown to improve medication adherence and clinical outcomes. Studies that included
      medical patients revealed that education can significantly reduce risk of ADRs after hospital
      discharge. Pharmacotherapeutic education is a part of comprehensive education of diabetics
      that is focused on a proper use of medications, prevention and early detection of ADRs. The
      aim of this study was to evaluate the impact of pharmacotherapeutic education on 30-day post
      discharge medication adherence and adverse outcomes (ADRs, readmissions, ED visits and death)
      in diabetic patients.
    

Intervention name(s): Education
Intervention type(s): Behavioral
Intervention description(s): Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care