Pharmaceutical care provided to liver transplant patients increases compliance with the immunosuppressive medication.
Approved by the Ethics Committee of the Medical Association of Rheinland-Pfalz (Landesaerztekammer Rheinland-Pfalz) on 23/06/2003. (ref: 873.166.03)
Prospective, randomized, controlled, single-center study.
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
In addition to routine clinical care, patients in the intervention group receive pharmaceutical care services provided by a dedicated hospital pharmacist. The Pharmaceutical Care program usually starts about 1 week before discharge from the transplant surgery unit. The hospital pharmacist meets the patient 3 to 4 times and educates him on different issues regarding immunosuppressive medication, e.g. action of the drugs, side effects, interactions, vital signs, laboratory data and discharge medication. On the day of discharge, the hospital pharmacist hands over and explains written information including a discharge medication plan, information regarding the immunosuppressive therapy, and a diary for documenting vital signs and laboratory data.
During the first year after transplantation, meetings with the care taking hospital pharmacist take place on a regular basis. The patient meets the pharmacist at least once every three months and maximum once per month. During these meetings the pharmacist discusses with the patient changes in medication, laboratory values and drug-related problems. Preferably, family members are involved. In addition, the hospital pharmacist reviews the patients' drug therapy, in order to assess and minimize drug related problems and simplify drug therapy.
Patients allocated to the control group receive the same medical care as the intervention group, except the direct pharmaceutical care described above.
Primary outcome measure
Compliance with immunosuppressive medication measured by MEMS® for 12 months, starting at discharge.
Secondary outcome measures
1. Compliance with immunosuppressive medication measured by the following:
1.1. Pill counts, performed at each ambulatory visit
1.2. Blood levels, performed at each ambulatory visit
1.3. Questionnaires at baseline, 6 and 12 months
2. Quality of life, measured by the 36-item Short Form health survey (SF-36) at discharge, 6 and 12 months after discharge
3. Patients' knowledge regarding drug therapy, assessed by interviews using a standardized questionnaire at 2 weeks after discharge, at first ambulatory visit and 12 months after discharge
4. Patients' satisfaction with the pharmaceutical care provided, assessed by a questionnaire developed for this trial at discharge
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Written informed consent
2. Age 18 years or older
3. First organ transplant
4. Follow-up care at the University Hospital Mainz for the first year after transplantation
5. Administration of oral immunosuppressive therapy as capsule or tablet
6. Literacy (German language)
Target number of participants
Participant exclusion criteria
Patients who are not willing to use the Medication Event Monitoring Systems® (MEMS®)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospital Mainz, Pharmacy Department (Germany)
University Hospital Mainz (Germany)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)