Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Solid organ transplant recipients (SOTR) must follow complex medication regimens and require a substantial amount of education for effective self-management. The current standard of care for post-transplant medication teaching is a Self Medication education program conducted in hospital by the pharmacist. The Transplant Medication Information Teaching Tool (TMITT) is a web-based e-learning tool for SOTR developed at the Toronto General Hospital. The ability to control the content, sequence, pace and timing of education in order to achieve personal learning objectives, as well as the opportunity for ongoing review and reinforcement of information, may be an attractive, convenient and effective teaching modality. SOTR will be randomly assigned to receive the standard of care or the standard of care plus the TMITT intervention. Primary objectives are to compare patient satisfaction and medication knowledge between the two groups at baseline and 3 months using modified versions of previously published questionnaires. Medication adherence as measured by a multidimensional approach including both subjective and objective components, will also be compared at 3 months. Our hypothesis is that an education strategy that includes both the standard pharmacist teaching followed by a tailored online e-learning intervention post-discharge will lead to improved patient satisfaction, knowledge and medication adherence.

Official Title
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Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial

Conditions
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Solid Organ Transplantation

Intervention / Treatment
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* Other: Transplant Medication Information Teaching Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients undergoing solid organ transplantation at Toronto General Hospital during the study period Exclusion Criteria: non-English speaking/reading no internet access at home planned discharge to a rehab facility without internet access not on a calcineurin inhibitor (CNI) or sirolimus attending the Self Medication class on the same day as hospital discharge cognitive impairment that precludes participation in Self Medication program (as per the assessment of the transplant pharmacist) incapable of providing informed consent
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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Patients in the Standard of Care arm receive the usual in-hospital post-transplant medication teaching class led by a transplant pharmacist. | |
| Active Comparator: TMITT<br>Patients in this arm receive the standard of care plus the TMITT educational intervention. | Other: Transplant Medication Information Teaching Tool<br>* Online e-learning tool for post-transplant medication education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Medication Knowledge Score from baseline to 3 months | Medication Knowledge Score consists of 2 parts - recall of medication regimen and multiple choice knowledge questionnaire. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient satisfaction with medication information received. | Baseline and 3 months | 
| Medication Adherence | Adherence to the immunosuppressant medication regimen is evaluated using the Multidimensional Adherence Classification System. This consists of patient self-report and measurement of standard deviation of immunosuppressant blood levels. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid organ transplantation, Immunosuppression, Education, E-learning, Medication knowledge, Patient satisfaction, Medication adherence