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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transplant Patients
• Intervention / Treatment: Other: Identification of the Problem and Development of the Care Bundle

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bilge Uğraş, PhD Candidate; Phone Number: +90534 238 66 09; Email: bilge.ugras.14@gmail.com
• Study Contact Backup: Name: Zeliha Özdemir Köken; Phone Number: +90505 586 63 46; Email: ozdemir.z@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Being 18 years of age or older
• Having no communication barriers
• Being literate
• Being able to speak and understand Turkish
• Having no diagnosed psychiatric disorder
• Meeting the discharge criteria from the clinic after organ transplantation

Exclusion Criteria:

• Being followed up in the intensive care unit due to complications or other reasons
• Unwillingness to continue participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pilot Testing of the Care Bundle, Evaluation of the Effectiveness of the Care Bundle	Other: Identification of the Problem and Development of the Care Bundle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HU-B-OTX-25001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No