Clinical trial NCT06652919: Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients
Official title: Development and Validation of Materials for the Pharmaceutical Care of Organ Transplant Recipients in Community Pharmacy: Survey on the Evaluation of Medication Information Leaflets for Organ Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Organ Transplantation
Keywords: Organ transplantation
Consumer Information Rating Form
Pharmaceutical Care
Community Pharmacy
Patient Information Leaflets
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone solid organ transplantation (kidney, liver, heart, lung) or their caregivers/family members

Brief summary: The aim of this study is to collect feedback from organ transplant patients or their caregivers/relatives on the medication information leaflets we've developed, using a questionnaire, and to adjust the content to better meet the specific needs of this unique patient group.

Detailed description: Introduction:

Organ transplantation is a life-saving procedure, but it also marks the beginning of a lifelong journey for patients. In 2023 alone, over 3,600 organ transplants were performed in Germany, with kidney, liver, heart, and lung transplants being the most common. Following a transplant, patients must take a combination of immunosuppressive medications to prevent their body from rejecting the new organ. These drugs, while essential, come with significant risks. Many of which have a very narrow therapeutic range and a high risk of drug interactions. Additionally, these medications have unique side effects that can affect mortality and health-related quality of life (HRQOL). As a result, organ transplant patients require constant medical monitoring and comprehensive education about their medications to ensure long-term graft survival and a better quality of life.

Community pharmacies in Germany have recognized the need to support these patients. Since 2022, community pharmacies have been offering pharmaceutical care services specifically tailored to organ transplant recipients, focusing on safe medication use and personalized counseling, including brown-bag reviews. This service is covered by health insurance and aims to reduce administration errors, improve therapy adherence, and enhance overall patient safety. However, despite nearly 4,000 new organ transplants each year, only a small fraction of these patients-less than 3%-benefit from these services annually. The reality is that public pharmacies rarely interact with transplant patients, as they make up a small group. Furthermore, there is currently a lack of adequate materials to support the provision of this service for transplant patients.

This research project addresses this gap by developing and validating specific materials that will help pharmacies deliver high-quality pharmaceutical care to organ transplant recipients. A key element of this project is the medication information leaflets designed by the investigators, which aim to enhance patients' understanding of their immunosuppressive therapy, reduce medication use errors, and ultimately improve medication safety.

The aim of this study is to collect feedback from organ transplant patients or their caregivers/relatives on these medication leaflets, using a questionnaire instrument called "Adapted Consumer Information Rating Form (CIRF)", developed by Krass et al. The results will help the investigators evaluate the quality of the medication information leaflets in terms of their content and design. This will also assist the investigators in adjusting the content to better meet the specific needs of this unique patient group in the future.

Study design:

This pilot study is designed as a descriptive survey. It involves a one-time survey, either online or in paper form, that collects data on participants' evaluations and opinions regarding the medication information sheets. The instrument that is used, the original Adapted CIRF, was initially translated by the investigators through a peer review process, including cultural adaptation from English to German. After two rounds of peer review, the final version was produced. Permission for the use and translation of the original Adapted CIRF was obtained from Krass et al. Additionally, demographic data will be collected in the study. This study was approved by the Ethics Committee: Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster.

The recruitment of the participants will be conducted through cooperating pharmacies and patient self-help groups, and participation in the questionnaire is voluntary. Data protection measures will be taken into account to ensure the confidentiality and security of participants' information.

Procedure for participation in the study:

1. The study begins as soon as the participants have agreed to the consent form.
2. The study consists of two parts. In Part 1, participants are asked to select a medication information sheet and thoroughly read it.
3. In Part 2, participants will ask to complete the questionnaire.
4. After completing the questionnaire, the participation is considered finished. The process will take approximately 10 to 20 minutes.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone solid organ transplantation (kidney, liver, heart, lung)
* Caregivers or family members of organ transplant patients
* German-speaking individuals
* adult

Exclusion Criteria:

* Individuals who are not able to provide consent
* Non-German-speaking individuals
* under 18 years old
* Patients who have undergone organ transplantation and are no longer taking immunosuppressants

Primary outcomes:
measure: Consumer Information Rating Form (CIRF): Mean "comprehensibility" score, mean "future use" score, mean "utility" score and mean "design quality" score.
timeFrame: 3 months
measure: Participants' characteristics
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Institute of Pharmaceutical and Medicinal Chemistry, Clinical Pharmacy, University of Münster
state: Nordrhein-Westfalen
Study officials:
References: