Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/09/2013
Date assigned
30/09/2013
Last edited
16/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Giuliano Piccoliori

ORCID ID

Contact details

via del Comune 39
S. Cristina
39047
Italy

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 risk–benefit 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 measures

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

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

Organisation

Council of Health Service of the Autonomous Province of Bolzano – South Tyrol (Italy)

Sponsor details

c/o Dr. Veronika Rabensteiner
Office for the Education and Training for the Healthcare Professions
M. Gamper Street 1
Bolzano
39100
Italy

Sponsor type

Government

Website

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: the overall trial end date was changed from 30/11/2015 to 01/12/2016.