Polypharmacy reduction in patients treated for chronic diseases
| ISRCTN | ISRCTN42003273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42003273 |
| Secondary identifying numbers | Ref. No. 01GY1332 |
- Submission date
- 07/01/2014
- Registration date
- 30/01/2014
- Last edited
- 24/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
altiner@med.uni-rostock.de
Contact information
Scientific
Rostock University Medical Center
Institute of General Practice
(Universitätsmedizin Rostock
Institut für Allgemeinmedizin)
POB 100888
Rostock
18055
Germany
| Phone | +49 (0)381 4942481 |
|---|---|
| altiner@med.uni-rostock.de |
Scientific
Rostock University Medical Center
Institute of General Practice
POB 100888
Rostock
18055
Germany
| christin.loeffler@med.uni-rostock.de |
Study information
| Study design | Cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Polypharmacy reduction in patients treated for chronic diseases a patient-centered approach utilizing the interface between secondary and primary care |
| Study acronym | POLITE-RCT |
| Study objectives | 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(s) | Ethics Committee at the Rostock University Medical Center, June 2014, ref: A 2014-0101 |
| Health condition(s) or problem(s) studied | Patients with chronic diseases and polypharmacy (≥ 5 prescribed long-term drugs) |
| Intervention | 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 | Other |
| 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 study start date | 01/11/2013 |
| Completion date | 31/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| 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. |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 31/10/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
18055
Germany
Sponsor information
Government
c/o Projektträger im DLR
Heinrich-Konen-Str. 1
Bonn
53227
Germany
| Phone | +49 (0)228 3821 1682 |
|---|---|
| Nicola.Grundmann@dlr.de | |
| Website | https://dlr.de |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | 31/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 06/10/2014 | Yes | No | |
| Results article | results | 06/10/2014 | Yes | No |
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.
