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 aged over 75 are treated with 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. It is thought 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 aged 75 and over, living in the community or in a nursing home, with >7 continuous drug prescriptions
What does the study involve?
Participating GP surgeries are randomly allocated to either the intervention group or the control group. The PRIMA-eDS tool is only available in the intervention group and not in the control group. The GPs in the intervention group use the PRIMA-eDS tool at the start of the study 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 is recorded which of the recommendations are followed by the GP. GPs in the control group are only 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, it is expected that the intervention will 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 is 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
Who is the main contact?
Univ. Prof. Dr. Andreas C. Sönnichsen
Andreas.Soennichsen@uni-wh.de
Trial website
Contact information
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?
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
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
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26822311