Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital.

N/ANot Yet RecruitingNCT07592624

Erasmus Medical Center308 enrolled

Overview

The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026. The main questions it aims to answer: The primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients. The study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care. The instructional video will be evaluated by a short questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

308

Conditions

Kidney Transplant Adult Medication Adherence

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is able to take the medication independently or with the help of someone else (professionals not included). * After admission, the patient is discharged to their own home or home of friend/relative. * The patient had a follow up at the outpatient clinic in the Erasmus Medical Center for at least one year after transplantation. * The patient is able to read the medication list or an illiteracy-friendly medication list. Exclusion Criteria: * Patients under 18 years of age * Patients who got discharged with a medication dispenser * Refusal to participate in the study. * Cognitive impairments that hinder participation. * Patients and/or family who can not understand (language barrier) the instructional video.

Outcomes

Primary Outcomes

Incidence and type of medication errors during admission

The primary outcome of this study will be the incidence (number of medication errors) and type of medication errors ( 1)Medication preparation omitted, 2) Incorrect dosage, 3) Incorrect administration at the scheduled time, 4), Medication discontinued inappropriately, 5)Error not documented by the nurse) during admission, evaluated through direct observation by healthcare providers. These errors will be documented and reported via patient portals by nurses.

Time frame: During admission

Secondary Outcomes

Patient characteristics

Age (in years), gender (male/female/nonbinair), country of origin, language proficiency, number of previous organ transplantations, donor type of the kidney transplant (DCD, DBD, Living), and renal replacement therapy (HD/PD/Pre-emptive).

Time frame: During admission

Evaluation of the instructional video

Structured questionnaire with the following questions: * Was the instructional video clear and easy to understand? (open answer) * Did you find the instructional video easy to follow? (open answer) * Do you have any suggestions for improvements? (open answer)

Time frame: At the end of admission

BAASIS

Participants will complete a patient-reported questionnaire (BAASIS) every three months during the first year after transplantation. The questionnaire consists of five yes/no questions related to medication errors occurring in the home setting. The questions will ask whether the participant has: 1. Forgotten to take their medication, (yes/no) 2. Taken the wrong dose of medication, (yes/no) 3. Taken medication at the wrong time, (yes/no) 4. Mixed up medications, (yes/no) 5. Not taken their medication due to confusion or difficulty. (yes/no) The goal is to evaluate whether there is a reduction in home-reported medication errors for those who receive a different medication management training method in the hospital.

Time frame: During the first year follow up at the out patient clinic after kidney transplantation in the Erasmus MC