The Prevention of Polypharmacy in Primary Care Patients Trial (4P-RCT)

ISRCTN	ISRCTN16560559
DOI	https://doi.org/10.1186/ISRCTN16560559
Protocol serial number	N/A
Sponsor	Institute of Primary Care - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)
Funders	Institute of Primary Care - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland), Gottfried und Julia Bangerter-Rhyner-Stiftung, Basel (Switzerland)

Submission date: 23/10/2014
Registration date: 31/10/2014
Last edited: 09/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The taking of multiple drugs (polypharmacy), overuse of drugs and misuse of drugs are increasing problems in the care of people with a number of health conditions (polymorbid) and the elderly. It leads to an increase in poor health (morbidity) , hospital admissions (hospitality rates), health related costs and number of deaths (mortality). Up to now, only few clinical tools to guide the withdrawal (deprescribing) of medicaments (drugs) are available. A recently published study using a newly developed algorithm for a systematic reduction of medication (Good Palliative Geriatric Practice, GPGP) showed that deprescribing resulted in a significant positive effects in the health in elderly people. Here, we slightly adapted the GPGP algorithm and carried out a study to how practical and acceptable it would be to use it in a primary care setting. The algorithm enforces a systematic drug reviewing considering patients perspective and preferences. As family doctors take care of a majority of polymorbid patients, our tool has a potentially high impact on polypharmacy in primary care settings. Up to now, studies carried out that test ways (interventions) to reduce polypharmacy in primary care settings are lacking. This study intends to bridge this gap.

Who can participate?
Primary care physicians in the Northern part of Switzerland and their polymorbid patients (60 years and older).

What does the study involve?
The practices are randomly allocated to either the intervention or the control group. The practices assigned to the intervention group will undergo a physician's training with instruction how to use the algorithm. The control group is given a lecture on polymorbidity and instructions for collecting data in a usual care activity. For the patients in the intervention group the practice nurse will create a list of what medication they currently take. Then the GP decides on the four major clinical problems and, together with the patient, the four most important complaints from the patients' perspective. Physicians now decide for every medicament listed whether its use is correct, whether there are side effects, whether an alternative treatment that should be tried or a change in the dose. After discussion, the patient and doctor decide together whether to stop a drug, to change the dose of a drug or to switch to an alternative drug, with the option to restart if symptoms should increase or the disease deteriorate. Patients of the control group receive care as usual.

What are the possible benefits and risks to participating?
The patients of the intervention group have the benefit of receiving a systematic drug review considering patients' perspective and preferences. Physicians will receive a financial incentive. Our study focuses on prescribing the appropriate medication, this includes the possibility to restart the stopped medication if it is necessary. Therefore, an additional risk is not expected.

Where is the study conducted?
University of Zurich (Switzerland)

When is the study starting and how long is it expected to run for?
January 2015 to September 2017 (updated 09/07/2019, previously: July 2017)

Who is funding the study?
1. Institute of Primary Care - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)
2. Gottfried und Julia Bangerter-Rhyner-Stiftung, Basel (Switzerland)

Who is the main contact?
Dr Stefan Neuner-Jehle
sneuner@bluewin.ch

Contact information

Dr Stefan Neuner-Jehle
Scientific

Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich
Pestalozzistrasse 24
Zürich
8091
Switzerland

Phone	+41 (0)41 711 0988
Email	sneuner@bluewin.ch

Study information

Primary study design	Interventional
Study design	Single-centre two-arm double-blind cluster-randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Systematic Deprescribing of medicaments in polymorbid primary care patients: a randomized-controlled study in Swiss General Practices
Study acronym	4P-Study
Study objectives	The implementation of an algorithm adapted to the Good Palliative Geriatric Practice (GPGP) algorithm to systematically deprescribe medicaments leads to a long-term reduction of polypharmacy among Swiss family doctors and their polymorbid patients (60 years and older). Furthermore, this implementation improves patients' quality of life and the course of the disease for which the drug was originally prescribed for (safety issues of the intervention).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Polypharmacy
Intervention	1. Practices in the control group: The control group is given a lecture on multimorbidity and instructions for collecting data in a usual care activity 2. Practices in the intervention group: Doctors in the intervention group undergo a physicians' training with instruction how to use the algorithm including a communication skills training. After obtaining informed consent from the patient, a practice nurse creates a list of patient's present medication. Then the GP defines the four major clinical problems and, together with the patient, the four most important complaints in patients' perspective. Physicians in the intervention group now decide for every medicament listed whether the indication is correct, whether there are side effects, whether an alternative treatment is making sense or whether a change in the dosage is indicated (key questions of the algorithm). After discussion with the patient doctor and patient decide together whether to stop a drug, to change the dosage of a drug or to switch to an alternative drug, with the option to restart if symptoms should increase or the disease deteriorate.
Intervention type	Other
Primary outcome measure(s)	Change in the number of drugs (deprescribing rate) 12 months after applying the deprescribing tool.
Key secondary outcome measure(s)	1. Change in the number of drugs immediately after the encounter and six months later 2. Reason for a change, categorized in the four options of the algorithm, number of drugs in each category 3. Discrepancy in the decision to quit, change or continue the drug between doctor and patient 4. Number of drugs the patient is taking not known to the doctor 5. Time consumption of the intervention 6. Disease-specific variables to evaluate the course of the disease(s) which the patient is treated for, including hospitalization and unexpected adverse event rates. Measurement will be performed by biometric analysis (e.g. blood pressure monitoring, serum glucose) and validated disease specific scores (e.g. pain, depression) 7. Number of drugs readopted due to an unfavorable course of the disease(s) (readoption rate) 8. Change in quality of life after 12 months, measured by a standardized short form questionnaire (EQ-5D) and a single Likert-scale item 9. Barriers perceived by patients against the approach / algorithm After the baseline assessment (including socioeconomic variables) systematic follow-up measurements will take place after six and 12 months.
Completion date	30/09/2017

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	430
Total final enrolment	334
Key inclusion criteria	1. Aged at least 60 years and capable of judgement 2. Taking five or more medicaments in the long term (six months or longer)
Key exclusion criteria	Life expectancy less than 12 months
Date of first enrolment	01/01/2015
Date of final enrolment	30/07/2016

Locations

Countries of recruitment

Switzerland

Study participating centre

Institut für Hausarztmedizin der Universität Zürich

Zürich
8091
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The majority of data will be included in the planned submissions. Other datasets generated during and/or analysed during the current study are planned to be available upon personal request from the Institute of Primary care, University of Zurich, Zurich, Switzerland. Contact stefan.zechmann@usz.ch .

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/08/2017	09/07/2019	Yes	No
Results article	results	14/05/2019	09/07/2019	Yes	No
Protocol article	protocol	26/08/2015		Yes	No
Basic results		14/09/2018	14/09/2018	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN16560559_BasicResults_14Sep18.pdf: Uploaded 14/09/2018

Editorial Notes

09/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2017 to 30/07/2016.
2. The overall end date was changed from 01/07/2017 to 30/09/2017.
3. The plain English summary was updated to reflect these changes.
4. Publication references added.
5. The total final enrolment was added.
17/09/2018: The following changes were made to the trial record:
1. The publication and dissemination plan was added.
2. The intention to publish date was added.
3. The participant level data was added.
4. The IPD sharing statement was added.
14/09/2018: The basic results of this trial have been uploaded as an additional file.