Impact of a pharmaceutical care program on liver transplant patients compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring

ISRCTN	ISRCTN83224156
DOI	https://doi.org/10.1186/ISRCTN83224156
Protocol serial number	N/A
Sponsor	University Hospital Mainz, Pharmacy Department (Germany)
Funder	University Hospital Mainz (Germany)

Submission date: 24/09/2007
Registration date: 30/10/2007
Last edited: 10/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Anja Klein
Scientific

Pharmacy Department
University Hospital Mainz
Langenbeckstr. 1
Mainz
55131
Germany

Study information

Primary study design	Interventional
Study design	Prospective, randomized, controlled, single-center study.
Secondary study design	Randomised controlled trial
Scientific title	Impact of a pharmaceutical care program on liver transplant patients compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring
Study objectives	Pharmaceutical care provided to liver transplant patients increases compliance with the immunosuppressive medication.
Ethics approval(s)	Approved by the Ethics Committee of the Medical Association of Rheinland-Pfalz (Landesaerztekammer Rheinland-Pfalz) on 23/06/2003. (ref: 873.166.03[3828])
Health condition(s) or problem(s) studied	Liver transplants
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	Compliance with immunosuppressive medication measured by MEMS® for 12 months, starting at discharge.
Key secondary outcome measure(s)	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
Completion date	30/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key 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)
Key exclusion criteria	Patients who are not willing to use the Medication Event Monitoring Systems® (MEMS®)
Date of first enrolment	01/09/2003
Date of final enrolment	30/03/2005

Locations

Countries of recruitment

Germany

Study participating centre

Pharmacy Department

Mainz
55131
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		27/03/2009	10/06/2021	Yes	No

Editorial Notes

10/06/2021: Publication reference added.

Impact of a pharmaceutical care program on liver transplant patients compliance with immunosuppressive medication - A prospective, randomized, controlled trial using electronic monitoring