Clinical trial NCT01826721: Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
Official title: Impact of an E-learning Tool on Patient Satisfaction, Knowledge and Medication Adherence in Solid Organ Transplantation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Organ Transplantation
Keywords: Solid organ transplantation
Immunosuppression
Education
E-learning
Medication knowledge
Patient satisfaction
Medication adherence
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 246
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Medication Knowledge Score from baseline to 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: Baseline and 3 months
measure: Medication Adherence
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto General Hospital
name: Jennifer Harrison, BScPhm, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Harrison 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.