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

Plain English Summary

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 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

Trial website

Type

Scientific

Primary contact

Dr Stefan Neuner-Jehle

ORCID ID

Contact details

Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich
Pestalozzistrasse 24
Zürich
8091
Switzerland
+41 (0)41 711 0988
sneuner@bluewin.ch

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Scientific title

Systematic Deprescribing of medicaments in polymorbid primary care patients: a randomized-controlled study in Swiss General Practices

Acronym

4P-Study

Study hypothesis

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

Not provided at time of registration

Study design

Single-centre two-arm double-blind cluster-randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measure

Change in the number of drugs (deprescribing rate) 12 months after applying the deprescribing tool.

Secondary outcome measures

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.

Overall trial start date

01/01/2015

Overall trial end date

01/07/2017

Reason abandoned (if study stopped)

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

215 patients and 16 - 17 practices are recruited in each arm (target recruitment number 430). Randomisation at GP level.

Participant exclusion criteria

Life expectancy less than 12 months

Recruitment start date

01/01/2015

Recruitment end date

01/07/2017

Countries of recruitment

Switzerland

Trial participating centre

Institut für Hausarztmedizin der Universität Zürich
Zürich
8091
Switzerland

Organisation

Institute of Primary Care - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)

Sponsor details

c/o Dr. Stefan Neuner-Jehle
Universitätsspital Zürich
Pestalozzistrasse 24
Zürich
8091
Switzerland
+41 (0)41 711 0988
sneuner@bluewin.ch

Sponsor type

University/education

Website

Funder type

Other

Funder name

Institute of Primary Care - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gottfried und Julia Bangerter-Rhyner-Stiftung, Basel (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD Sharing Statement: 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 .

Intention to publish date

01/01/2019

Participant level data

Available on request

Basic results (scientific)

See additional file (ISRCTN16560559_BasicResults_14Sep18.pdf)

Publication list

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26306691

Publication citations

• ISRCTN16560559_BasicResults_14Sep18.pdf Uploaded 14/09/2018

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.