Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
1 other identifier
interventional
246
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedApril 8, 2013
April 1, 2013
1.4 years
April 1, 2013
April 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Patient Satisfaction
Baseline and 3 months
Medication Adherence
3 months
Study Arms (2)
Standard of Care
NO INTERVENTIONPatients in the Standard of Care arm receive the usual in-hospital post-transplant medication teaching class led by a transplant pharmacist.
TMITT
ACTIVE COMPARATORPatients in this arm receive the standard of care plus the TMITT educational intervention.
Interventions
Online e-learning tool for post-transplant medication education.
Eligibility Criteria
You may qualify if:
- all patients undergoing solid organ transplantation at Toronto General Hospital during the study period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Related Publications (2)
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PMID: 36094829DERIVEDHarrison JJ, Badr S, Hamandi B, Kim SJ. Randomized Controlled Trial of a Computer-Based Education Program in the Home for Solid Organ Transplant Recipients: Impact on Medication Knowledge, Satisfaction, and Adherence. Transplantation. 2017 Jun;101(6):1336-1343. doi: 10.1097/TP.0000000000001279.
PMID: 27367473DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Harrison, BScPhm, MSc
University Health Network, Toronto General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Pharmacy Clinical Site Leader
Study Record Dates
First Submitted
April 1, 2013
First Posted
April 8, 2013
Study Start
May 1, 2011
Primary Completion
October 1, 2012
Study Completion
March 1, 2013
Last Updated
April 8, 2013
Record last verified: 2013-04