Clinical trial NCT03438162: Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes
Official title: Impact of Pharmacotherapeutic Education on Medication Adherence and Adverse Outcomes in Type 2 Diabetes Mellitus Patients: Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Education
Drug-Related Side Effects and Adverse Reactions
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older,
* diagnosis of T2DM and
* hospital discharge to the community.

Exclusion Criteria:

* cognitive disorders that would interfere with patient's participation,
* diagnosis of a terminal illness with a life expectancy \<1 month,
* discharge to a long-term care facility or
* inability to be followed-up.

Primary outcomes:
measure: Medication adherence assessment method
timeFrame: one month
Secondary outcomes:
measure: Adverse events questionnaire
timeFrame: one month
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Srećko Marušić
role: STUDY_CHAIR
References:
citation: Marusic S, Melis P, Lucijanic M, Grgurevic I, Turcic P, Neto PRO, Bilic-Curcic I. Impact of pharmacotherapeutic education on medication adherence and adverse outcomes in patients with type 2 diabetes mellitus: a prospective, randomized study. Croat Med J. 2018 Dec 31;59(6):290-297. doi: 10.3325/cmj.2018.59.290.