Development, Pilot Testing and Evaluation of the Effectiveness of Immunosuppressive Medication Adherence Care Bundle in Patients Undergoing Solid Organ Transplantation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHacettepe University

About this trial

Organ transplantation is the gold standard treatment method that increases the quality and duration of life in patients with end-stage organ failure, and one of the most important complications after transplantation is graft rejection. Immunosuppressive therapy is critically important in preventing rejection and preserving graft function. Although non-adherence to immunosuppressive therapy is a risk factor for poor clinical outcomes after transplantation, it is often not well managed, and only a small proportion of interventions aimed at improving medication adherence can be translated into clinical practice. Therefore, there is a need to develop a care bundle that includes evidence-based practices to standardize interventions aimed at improving adherence to immunosuppressive medication use in organ transplant recipients, improve patient outcomes, and enhance the quality of care.

This mixed-methods study is planned to develop and test an immunosuppressive medication adherence care bundle for solid organ transplant recipients using the Knowledge-to-Action (KTA) framework. The study will be conducted with patients who have undergone heart transplantation at the Heart Transplantation Clinic of Ankara Bilkent City Hospital Cardiovascular Hospital. Data will be collected using the "Patient Information Form," "Immunosuppressive Medication Adherence Care Bundle Checklist," "Care Bundle Adherence Evaluation Form," "Semi-structured Interview Form," and the "Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS©)."

The study will be carried out in three phases: identification of the problem and development of the care bundle (Phase 1), pilot implementation (Phase 2), and effectiveness evaluation (Phase 3). Through this study, an evidence-based immunosuppressive medication adherence care bundle for solid organ transplant recipients will be introduced to the literature using the KTA framework. The developed care bundle is expected to standardize practices related to the management of adherence to immunosuppressive medications and promote the use of evidence-based practices in patient care in clinical settings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being 18 years of age or older

Having no communication barriers

Being literate

Being able to speak and understand Turkish

Disqualifiers

Being followed up in the intensive care unit due to complications or other reasons

Unwillingness to continue participating in the study

Trial design

Design model

Single group

Treatments tested in this trial

  • Identification of the Problem and Development of the Care Bundle

    Other intervention

    There is a need to develop a care bundle that includes evidence-based practices to standardize interventions aimed at improving adherence to immunosuppressive medication use in organ transplant recipients, improve patient outcomes, and enhance the quality of care.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care BundleOther 1 intervention

Trial outcomes

Primary outcomes

1

Care bundle adherence

Care package compliance will be evaluated at the end of the pilot implementation (at 6 months) by assessing heart transplant patients' adherence to immunosuppressive medication using the BAASIS© scale. The compliance rate with the care package parameters, calculated using the formula recommended by the Institute for Healthcare Improvement (IHI), will indicate the success of care package adherence. A calculated rate below 95% will be considered as unsuccessful adherence to the care package.

Time frame
6 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: