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

Solid Organ Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826721
• Other study ID #: REB10-0987-AE
• Status: Completed
• Phase: N/A
• First received: April 1, 2013
• Last updated: April 3, 2013
• Start date: May 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University Health Network Research Ethics Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: March 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Solid Organ Transplantation

Intervention

Other:
• Transplant Medication Information Teaching Tool
Online e-learning tool for post-transplant medication education.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Harrison

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Patient Satisfaction	Patient satisfaction with medication information received.	Baseline and 3 months	No
Secondary	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	No

External Links

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