Condition category
Not Applicable
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
More and more people are now suffering from long-term diseases and multimorbidity (multiple medical conditions in one person), and are treated with an increasing number of long-term drugs. However, polypharmacy (use of multiple medications by a patient) involves severe risks for patient safety. Also, patients are often unable to monitor their frequency of dosage. Reducing inappropriate polypharmacy will contribute to lower levels of adverse drug events and drug-related side effects and will increase patient safety and quality of life. This study will test the effectiveness of an intervention (use of pharmacist-based narrative medication review) within hospitals and aims at reducing the number of long-term prescribed drugs among multimorbid and chronically ill patients.

Who can participate?
Patients aged 60 years and older, taking five or more prescribed long-term drugs, and likely to spend at least one week in the hospital.

What does the study involve?
The hospital wards are randomly allocated to either the intervention or the control group. Patients in the intervention wards receive a pharmacist-based narrative medication review in hospital. Patients in the control group wards receive care as usual. The number of prescribed long-term medications are compared between both groups at 12 months after discharge as well as health-related quality of life.

What are the possible benefits and risks of participating?
The findings of this study may result in a major impact on reducing polypharmacy by enhancing both patient-centeredness and patient autonomy. No risks to participants are expected.

Where is the study run from?
Two hospitals in Mecklenburg-Western Pomerania (Germany)

When is the study starting and how long is it expected to run for?
November 2013 to August 2017

Who is funding the study?
German Federal Ministry of Education and Research (BMBF) (Germany)

Who is the main contact?
Prof. Dr med. Attila Altiner

Trial website

Contact information



Primary contact

Prof Attila Altiner


Contact details

Rostock University Medical Center
Institute of General Practice
(Universitätsmedizin Rostock
Institut für Allgemeinmedizin)
POB 100888
+49 (0)381 4942481



Additional contact

Dr Christin Löffler


Contact details

Rostock University Medical Center
Institute of General Practice
POB 100888

Additional identifiers

EudraCT number number

Protocol/serial number

Ref. No. 01GY1332

Study information

Scientific title

Polypharmacy reduction in patients treated for chronic diseases – a patient-centered approach utilizing the interface between secondary and primary care



Study hypothesis

Whether a patient-centered medication review performed by pharmacists and consented with the patients’ General Practitioners will be effective to sustainably reduce polypharmacy.

Ethics approval

Ethics Committee at the Rostock University Medical Center, June 2014, ref: A 2014-0101

Study design

Cluster-randomized controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Patients with chronic diseases and polypharmacy (≥ 5 prescribed long-term drugs)


During in-patient treatment of chronically ill patients affected by polypharmacy, a pharmacist specially trained in communication skills performs a narrative-based medication review. Apart from detecting potentially inadequate medication, a major aim is to identify patient preferences and to include them - whenever possible - into a list of evidence-based medication recommendations. Patients will be motivated to narrate the drugs they currently take and describe their experiences and expectations related to these drugs. Based on this information the pharmacist prepares a list of possible drugs to be stopped, which will then be discussed with the hospital physician in charge and will be submitted for consent to the patients’ General Practitioner. The active involvement of patients allows for transparency of the decision-making process and will increase the chance for a sustainable medication optimization.

Patients of the control group receive care as usual.

The intervention in the intervention group will take place once, shortly after the admission to hospital. The duration of the entire trial will be 36 months.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The two independent main outcomes are:
1. Health-related quality of life, measured using the EQ-5D
2. The difference in the number of prescribed long-term pharmaceutical agents between intervention and control group at T3. Primary outcome is defined as pharmaceutical agents rather than number of drugs because combination drugs are commonly used in Germany.

During the baseline and intervention periods, primary outcomes for each patient will be measured at four points in time: at admission to the hospital (T0) and discharge from hospital (T1), as well as 6 (T2) and 12 months (T3) after discharge from the hospital.

Secondary outcome measures

1. Appropriateness of prescribed medication
2. Patient satisfaction
3. Patient empowerment
4. Patient autonomy
5. For all patients insured with the largest public German health insurance provider AOK, cost effectiveness and further aspects of quality of care will be analyzed

Measured at T0, T2 and T3

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Two local hospitals will recruit patients with chronic diseases and polypharmacy meeting the following inclusion criteria:
1. Aged 60+ years
2. Taking ≥ 5 prescribed long-term drugs
3. Likely to spend at least one week in the hospital

Participant type


Age group




Target number of participants

1,626 patients. After baseline: stratified randomization of participating wards. Wards allocated to control and intervention group will recruit another 1,626 patients.

Participant exclusion criteria

1. Inability to take their medication by themselves
2. Inability to give informed consent (e.g. due to dementia)
3. Severe language difficulties
4. Diseases that usually make poly-pharmacotherapy unavoidable (e.g. active malignoma, acquired immunodeficiencies [HIV], hemodialysis)
5. Presumed life expectancy of less than 12 months

Added 20/01/2017:
6. Patients being diagnosed with any type of cancer after recruitment will be excluded from the study

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Rostock University Medical Center

Sponsor information


German Federal Ministry of Education and Research (BMBF) (Germany)

Sponsor details

c/o Projektträger im DLR
Heinrich-Konen-Str. 1
+49 (0)228 3821 1682

Sponsor type




Funder type


Funder name

Bundesministerium für Bildung und Forschung (Ref. No. 01GY1332)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2014 protocol in:
2015 results in:

Publication citations

  1. Protocol

    Löffler C, Drewelow E, Paschka SD, Frankenstein M, Eger J, Jatsch L, Reisinger EC, Hallauer JF, Drewelow B, Heidorn K, Schröder H, Wollny A, Kundt G, Schmidt C, Altiner A, Optimizing polypharmacy among elderly hospital patients with chronic diseases¿study protocol of the cluster randomized controlled POLITE-RCT trial., Implement Sci, 2014, 9, 1, 151, doi: 10.1186/s13012-014-0151-7.

Additional files

Editorial Notes

20/01/2017: The overall trial end date was changed from 31/10/2016 to 31/08/2017. 17/11/2015: Publication reference added.