Plain English Summary
Background and study aims
In the treatment of patients with long-term illness, treatment with many drugs (polypharmacy) is common. Polypharmacy in elderly patients is often associated with an inadequate use of drugs, which leads to more drug-drug interactions, adverse drug events, hospital admissions and rising costs for the health system. A big part of the drugs in polypharmacy is prescribed without demonstrated benefit for the patient. In this study we want to show that the reduction of drugs especially in elderly patients leads to a reduction of mortality (death), hospital admissions, falls and fractures and to a better mental functioning and quality of life of patients.
Who can participate?
People aged 74 or older with a drug therapy of eight drugs or more.
What does the study involve?
General practitioners (GPs) will be randomly allocated to one of two groups. GPs from one group will provide standard care to their patients. GPs from the other group will check the therapies of their patients in consultation with a panel of expert's which will check the drugs regarding appropriateness, possible dangerous side effects, medical indication and age of the patients. Together, they will select drugs which can be discontinued. The GP will have the last decision on discontinuation of a drug - in consultation with the patient. At the beginning and at the end of the study several tests will be carried out and results will be compared. Also, for assessing the quality of life, the cognitive (mental) function and the mental wellbeing of the patients, interviews will be carried out at the beginning and at the end of the study.
What are the possible benefits and risks of participating?
There may be a benefit for the patients taking part in terms of a thorough check of their drug therapy and eventually a reduction of the number of drugs to be taken. Consequently, there may be a reduction of side effects and undesired interactions between two or more drugs. The risk with discontinuation of drugs is that the disease or the overall health status depending on the underlying diseases will get worse. Therefore, patients will be checked and followed very carefully by their GP. And, within the study, discontinued drugs can be reintroduced in the therapy at any time.
Where is the study run from?
South Tyrolean Academy of General Practice, Bolzano, Italy
When is the study starting and how long is it expected to run for?
December 2012 to November 2015
Who is funding the study?
The Italian Ministry of Health and Council of Health Service of the Autonomous Province of Bolzano South Tyrol
Who is the main contact?
1. Prof. Christian Wiedermann (christian.wiedermann@asbz.it)
2. Dr Giuliano Piccoliori
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RF-2010-2319605
Study information
Scientific title
Polypharmacy - Reduction of Inappropriate Medication and Adverse drug events in older patients: a randomized controlled trial
Acronym
PRIMA
Study hypothesis
1. The evaluation of polypharmacy according to established criteria will lead to reduced polypharmacy, potential adverse drug interactions, hospital admissions and referrals to emergency departments.
2. The reduction of polypharmacy will be accompanied by an improvement of quality of life, mental functioning and mental wellness.
Ethics approval
Ethics committee of Bolzano, 15/05/2013, ref: 42-2013
Study design
Cluster randomized controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Reduction of polypharmacy in elderly patients
Intervention
A cluster-randomized controlled trial aiming at the outcome after reduction and/or discontinuation of inappropriate medication in older patients. In the proposed trial, the physicians will be randomized with a computer tool (cluster) to receive or not receive advice from the experts board.
Intervention group:
1. Recommendation for discontinuation of drugs by a panel of experts in consultation with the general practitioner
2. Discontinuation of drugs with no evidence for benefit or even negative riskbenefit balance according to the Garfinkel Algorithm, the EbM guidelines and UpToDate software, PRISCUS list, STOPP Criteria and the drug interaction database.
Control: physicians of the control group will record and document their patients the same way (CRF Form), but won't get advice on the drug therapy from the experts board.
Both groups, intervention and control, will have to record / document consecutively any events of death, falls, adverse drug events (ADEs) and bone fractures.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Hazard ratio for the composite endpoint of first hospital admission and death measured by the number of deaths in the study population at 24 months
Secondary outcome measures
1. Mortality, measured by the number of deaths (the numerator of the mortality rate) in patients of the two study groups (the population denominator of the mortality rate), respectively, at the time point 24 months after study enrolment
2. Hospital admission, measured as number of admissions to local hospitals and length of hospital stays measured in days as recorded in a single database within a time period of 24 months after study enrolment
3. Adverse drug events, measured as number of severe adverse events documented in patients charts of the general practitioner or in hospital discharge letters in patients of the two study groups, respectively, at the time point 24 months after study enrolment
4. Falls, measured as number of events which result in a person coming to rest inadvertently on the ground or floor or other lower level as documented in patient charts of the general practitioner and of the hospital in patients of the two study groups, respectively, during the period of 24 months after study enrolment
5. Fractures, measured as number of bone fractures documented radiographically in charts of patients of the two study groups, respectively, during the period of 24 months after study enrolment
6. Health expenditure, measured as estimated sum of the expenditure due drugs and hospital admissions in patients of the two study groups, respectively, at the time point 24 months after study enrolment
7. Improvement of the cognitive function assessed by the Mini Mental Status
8. Quality of life, measured by the SF12
9. Mental wellness, assessed by the Geriatric Depression Scale
Overall trial start date
01/12/2012
Overall trial end date
01/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged over 74 years
2. Taking eight or more drugs
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Life expectancy assumed to be less than three months
2. Advanced cancer
3. Ongoing chemotherapy and/or therapeutic radiation
4. Severe dementia
5. Patients not able to give informed consent
Recruitment start date
01/12/2012
Recruitment end date
30/11/2015
Locations
Countries of recruitment
Italy
Trial participating centre
via del Comune 39
S. Cristina
39047
Italy
Sponsor information
Funders
Funder type
Government
Funder name
Ministero della Salute
Alternative name(s)
Ministry of Health, Italy
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Italy
Funder name
Council of Health Service of the Autonomous Province of Bolzano South Tyrol (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Dr. Piccoliori Giuiano, drgiupic@tin.it, in SPSS format starting from 01/06/2018 for 10 years. Data will be made available only for scientific purposes and analyses, individual participant data will be pseudonymized.
Intention to publish date
15/09/2018
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN38449870_BasicResults_11Jan18
Publication list