Condition category
Signs and Symptoms
Date applied
31/07/2014
Date assigned
31/07/2014
Last edited
26/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic multimorbidity is rising in our aging population and leads to polypharmacy as a result of guideline adherent and also non-evidence based or inappropriate drug treatment of chronic diseases. Depending on definitions and setting between 25 and 50% of all patients > 75 years are exposed to five or more drugs. Inappropriate polypharmacy of older patients poses a serious threat to health and well-being. While there exists only limited evidence regarding the benefit of polypharmacy, the evidence regarding potential harm of inappropriate medication is increasing. An electronic tool, the “PRIMA-electronic decision support (eDS) tool”, will be developed to make current best evidence available to general practitioner (GP) in daily practice. The GP has to enter the patient’s diagnoses, current medication including drugs that have not been prescribed by the GP, and general patient data like sex, age, height and weight. The GP will receive medication-related recommendations generated by the PRIMA-eDS tool on-screen. The medication can then be revised by the GP in a shared decision making process with the patient. The principal hypothesis is that the reduction of polypharmacy and inappropriate prescribing according to current best evidence supported by the PRIMA-eDS tool will improve the clinical composite outcome of first hospitalization and death of older patients with multiple chronic diseases.

Who can participate?
Patients at the age of 75 years and above, male and female, living in the community or in a nursing home, with >7 continuous drug prescriptions willing to participate and able to sign informed consent according to the declaration of Helsinki.

What does the study involve?
The PRIMA-eDS tool will only be available in the intervention group and not in the control group. The GP in the intervention group uses the PRIMA-eDS tool at baseline and at each follow up visit (study visits are scheduled after 8 months, 16 months, and 24 months) or any time in between visits. It will be recorded which of the recommendations were followed by the GP. GPs in the control group will only be asked to record general data and the medication of the participating patients at the same time points as the intervention group with no advice given to continue or discontinue any of the drugs. GPs in the control group are advised to apply usual care according to current guidelines.

What are the possible benefits and risks of participating?
The study will provide new insights in the possible risks and benefits of polypharmacy in older multimorbid patients suffering from chronic diseases. A reduction in hospital admission and death rate by reducing polypharmacy as primary endpoint will be a clear indicator of improvement for patients with chronic diseases. Furthermore, we expect the intervention to result in a marked improvement of quality of life as well as physical and mental functioning of older people.

Where is the study run from?
The PRIMA-eDS study will be coordinated by Witten/Herdecke University and carried out by five university-based centres recruiting GP-surgeries in their particular region/country.
1. University of Witten/Herdecke (Germany) – leading centre and coordinator
2. University of Manchester (UK)
3. University of Rostock (Germany)
4. Paracelsus Medical University (Austria)
5. South Tyrolean Academy for General Practice (Italy)
Each centre will enrol 67 GP practices (in total 335 practices).

When is the study starting and how long is it expected to run for?
A pilot study has been started in June 2014 and will be completed in December 2014. The main trial will start in December 2014 (start of recruitment). The last follow up visit will be scheduled two years after the last patient has been included in the study.

Who is funding the study?
Seventh EU Framework Programme, Health-2012-Innovation-1-2.2.2.-2 grant agreement no. 305388-2.

Who is the main contact?
Univ. Prof. Dr. Andreas C. Sönnichsen
Andreas.Soennichsen@uni-wh.de

Trial website

http://www.prima-eds.eu/

Contact information

Type

Scientific

Primary contact

Prof Andreas Sönnichsen

ORCID ID

Contact details

Witten/Herdecke University (Universität Witten/Herdecke)
Institute of General Practice and Family Medicine (Institut für Allgemeinmedizin und Familienmedizin)
Alfred-Herrhausen-Straße 50
Witten
58448
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Polypharmacy in chronic diseases - reduction of inappropriate medication and adverse drug events in elderly populations by electronic decision support: a multicenter cluster-randomized controlled trial

Acronym

PRIMA-eDS

Study hypothesis

Do multimorbid older patients in primary care taking eight drugs or more benefit from the implementation of the electronic decision support tool “PRIMA-eDS” which suggests a reduction of polypharmacy according to current best evidence, compared to patients with polypharmacy receiving usual care, regarding the combined endpoint of hospital admission and death?

On 25/08/2015 the target number of participants was changed from '3685 patients in 335 clusters' to '3575 patients in 325 clusters'.

Ethics approval

1. Ethikkomission der Universität Witten/Herdecke, 03/12/2013, ref. 103/2013
2. NRES Committee North West - Greater Manchester East, 06/06/2014, ref. 14/NW/0197
3. Ethikkommission für das Bundesland Salzburg, 15/09/2013, ref. 08.04.2014 (415-E/1509/20-2014)
4. Ethikkommission der Universitätsmedizin Rostock, 03/02/2014, ref. A 2014-0020
5. Comitato etico di Belluno ( Azienda ULSS), 26/06/2013, ref. 305388-2

Study design

Multicenter 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 to request a participant information sheet

Condition

Multimorbid older patients in primary care

Intervention

The PRIMA-eDS tool will only be available in the intervention group and not in the control group. The GP in the intervention group uses the PRIMA-eDS tool at each follow up visit (study visits are scheduled at baseline and after 8 months, 16 months, and 24 months). It will be recorded which of the recommendations were followed by the GP. GPs in the control group will only be asked to record general data and the medication of the participating patients at the same time points as the intervention group with no advice given to continue or discontinue any of the drugs. GPs in the control group are advised to treat their patients applying usual care adherent to current guidelines.

Follow Up Length: 24 months; Study Entry: Single Randomisation only

Intervention type

Other

Phase

Drug names

Primary outcome measures

Composite of first hospitalization and death measured at 24 months.

Secondary outcome measures

Current secondary outcome measures as of 25/08/2015:
1. All cause mortality
2. Hospital admission (number of episodes and duration)
3. Falls
4. Fractures
5. Quality of life
6. The number and types of drugs discontinued
7. The number and types of drugs not discontinued despite the recommendation to discontinue
8. The number and types of drugs re-administered for symptom control
9. Medication costs
10. Adverse event rate
All measured at baseline, 8, 16, and 24 months.

Previous secondary outcome measures:
1. All cause mortality
2. Hospital admission (number of episodes and duration)
3. Falls
4. Fractures
5. Quality of life
6. The number and types of drugs discontinued
7. The number and types of drugs not discontinued despite the recommendation to discontinue
8. The number and types of drugs re-administered for symptom control
9. Medication and health care costs
All measured at baseline, 8, 16, and 24 months.

Overall trial start date

01/12/2014

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age of 75 years and above living in the community or in a nursing home
2. At least 8 continuous drug prescriptions
3. Willing to participate
4. Able to sign informed consent according to the declaration of Helsinki

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 3575 patients in 325 clusters (GP practices)

Participant exclusion criteria

1. Patients with a life expectancy assumed to be less than 1 year, e.g. patients with advanced cancer
2. Patients receiving chemotherapy and/or therapeutic radiation
3. Patients with dementia who are unable to provide informed consent

Recruitment start date

01/12/2014

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Austria, Germany, Italy, United Kingdom

Trial participating centre

Witten/Herdecke University (Universität Witten/Herdecke) - leading centre and co-ordinator
Institute of General Practice and Family Medicine (Institut für Allgemeinmedizin und Familienmedizin) Alfred-Herrhausen-Straße 50
Witten
58448
Germany

Trial participating centre

The University of Manchester
5th Floor Williamson Building Oxford Road
Manchester
M13 9PL
United Kingdom

Trial participating centre

University of Rostock (Universität Rostock)
Rostack
18051
Germany

Trial participating centre

Paracelsus Medical University (Die Paracelsus Medizinische Privatuniversität)
Strubergasse 21
Salzburg
5020
Austria

Trial participating centre

South Tyrolean Academy for General Practice (Südtiroler Akademie für Allgemeinmedizin)
Wangergasse, 18
Bozen-Bolzano
I-39100
Italy

Sponsor information

Organisation

Witten/Herdecke University (Universität Witten/Herdecke)

Sponsor details

Alfred-Herrhausen-Straße 50
Witten
58448
Germany

Sponsor type

University/education

Website

www.uni-wh.de

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

The study protocol will be published in 2015. Primary outcome data will be published in 2017.

Intention to publish date

30/11/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes