PRIMA-eDS: Polypharmacy in chronic diseases: Reduction of Inappropriate Medication and Adverse drug events in elderly populations by electronic Decision Support

ISRCTN ISRCTN10137559
DOI https://doi.org/10.1186/ISRCTN10137559
Secondary identifying numbers N/A
Submission date
31/07/2014
Registration date
31/07/2014
Last edited
22/06/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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?
December 2014 to November 2017 (as of 04/10/2018)

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

Study website

Contact information

Prof Andreas Sönnichsen
Scientific

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

Study information

Study designMulticenter cluster-randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePolypharmacy in chronic diseases - reduction of inappropriate medication and adverse drug events in elderly populations by electronic decision support: a multicenter cluster-randomized controlled trial
Study acronymPRIMA-eDS
Study objectivesDo 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(s)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
Health condition(s) or problem(s) studiedMultimorbid older patients in primary care
InterventionThe 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 typeOther
Primary outcome measureComposite of first hospitalization and death measured at 24 months
Secondary outcome measuresCurrent 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 study start date01/12/2014
Completion date30/11/2017

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsPlanned Sample Size: 3575 patients in 325 clusters (GP practices)
Total final enrolment3904
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2014
Date of final enrolment30/09/2015

Locations

Countries of recruitment

  • Austria
  • England
  • Germany
  • Italy
  • United Kingdom

Study participating centres

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
The University of Manchester
5th Floor Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
University of Rostock (Universität Rostock)
Rostack
18051
Germany
Paracelsus Medical University (Die Paracelsus Medizinische Privatuniversität)
Strubergasse 21
Salzburg
5020
Austria
South Tyrolean Academy for General Practice (Südtiroler Akademie für Allgemeinmedizin)
Wangergasse, 18
Bozen-Bolzano
I-39100
Italy

Sponsor information

Witten/Herdecke University (Universität Witten/Herdecke)
University/education

Alfred-Herrhausen-Straße 50
Witten
58448
Germany

Website www.uni-wh.de
ROR logo "ROR" https://ror.org/00yq55g44

Funders

Funder type

Government

Seventh Framework Programme
Government organisation / National government
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Results and Publications

Intention to publish date30/11/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe study protocol will be published in 2015. Primary outcome data will be published in 2017.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 29/01/2016 Yes No
Other publications baseline analysis 18/07/2018 Yes No
Other publications cross-sectional analysis of participant characteristics 18/07/2018 12/09/2019 Yes No
Results article results 18/06/2020 22/06/2020 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

22/06/2020: Publication reference added.
12/09/2019: Publication reference and total final enrolment added.
04/10/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 30/09/2017 to 30/11/2017
2. The plain English summary has been updated
20/07/2018: Publication reference added.
12/09/2017: IPD sharing statement added.
06/06/2017: Publication reference added.
25/08/2015: The target number of participants was changed from '3685 patients in 335 clusters' to '3575 patients in 325 clusters'.