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Implementing recommendations for Polypharmacotherapy of multimorbid Patients (PomP)
ISRCTN ISRCTN34664024
DOI 10.1186/ISRCTN34664024
ClinicalTrials.gov identifier
EudraCT number
Public title Implementing recommendations for Polypharmacotherapy of multimorbid Patients (PomP)
Scientific title A tailored implementation intervention to implement recommendations addressing Polypharmacotherapy of multimorbid Patients (PomP): study protocol of a cluster-randomized controlled trial
Acronym PomP
Serial number at source European Union EU Framework 7 program, theme HEALTH.2013.3.1-1, grant agreement no 258837
Study hypothesis The hypothesis is that physicians participating in a tailored implementation program succeed more in implementing recommendations for the treatment of multimorbid patients receiving polypharmacotherapy than physicians not participating in this program.

The null hypothesis is that there is no difference between these two groups.
Lay summary Background and study aims
Three evidence-based recommendations addressing polypharmacotherapy (use of multiple therapies to treat disease) in primary care are: structured medication counselling, use of medication lists, and medication reviews to avoid potentially inappropriate medication (PIM). Although promising to improve patient outcomes, these recommendations are not well implemented in German routine care. This study examines a tailored intervention to implement the recommendations addressing polypharmacotherapy into primary care practices.

Who can participate?
Primary care physicians (PCP) who are enrolled in a general practice centered care contract of a German health insurance (HZV AOK) and organised in quality circles with three-monthly meetings will be recruited as participants of the study. Each PCP will include 2025 patients aged > 64 years, being diagnosed with more than two chronic conditions and being repeatedly prescribed more than four drugs.

What does the study involve?
The practices are randomly allocated to either the intervention or the control group. From the practices assigned to the intervention group at least one physician and one health care assistant will participate in a workshop about polypharmacotherapy. The practice teams will create an individual concept which describes how they are planning to implement the recommendations into their practice. They will put their concept into practice and perform medication reviews and medication counselling for the included patients. Checklists, posters and flyers will be offered to them to facilitate implementation. Patients in the intervention group will complete an educational tool concerning medication-related topics on a tablet PC. Patients and physicians of the control group will perform care as usual and will not receive any special training or information material.

What are possible benefits and risks of participating?
The patients of the intervention group have the benefit of receiving intensified medication management. Physicians will receive a financial allowance.The intervention aims at changing organisational processes in German primary care practices and does not include any specific treatment for patients. Therefore, an additional risk is not expected.

Where is the study run from?
The study is conducted by the Department of General Practice and Health Care Researches of the University of Heidelberg.

When is the study starting and how long is it expected to run for?
The recruitment is expected to start in August 2013. Participants will be enrolled on the study for a period of 6 months.

Who is funding the study?
This study is funded by the European Union.

Who is the main contact?
Dr Cornelia Jäger, Department of General Practice and Health Services Research , University of Heidelberg
Cornelia.jaeger@med.uni-heidelberg.de
Ethics approval Ethical approval pending from the Ethical Review Committee of the University of Heidelberg, Germany.
Study design 6 months cluster randomized controlled trial
Countries of recruitment Germany
Disease/condition/study domain Implementation of recommendations for polypharmacotherapy in multimorbid patients
Participants - inclusion criteria For general practitioners:
1. Enrolment in a general practice centred care contract (HZV AOK Baden-Wuerttemberg)
2. Continuous attendance in a specific quality circle every three months in the previous 12 months

For patients:
1. Aged over 64 years
2. Enrolment in general practice-centred care contract (HZV AOK Baden-Wuerttemberg)
3. Repeated prescriptions of more than four drugs in one quarter of the year
4. Being diagnosed with at least three chronic conditions
5. Especially in need for intensified medication management (according to the personal assessment of the general practitioner, e.g. non-adherence, hospitalisation due to medication related events).
Participants - exclusion criteria 1. For physicians: Physicians having participated in another study focusing on multimorbidity or polypharmacotherapy in the last year are excluded
2. For patients: Lacking ability or need for intensified medication management according to the personal assessment of the general practitioner.
Anticipated start date 01/11/2013
Anticipated end date 01/06/2014
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 40 primary care practices, 1000 patients
Interventions Practice teams (1 general practitioner, 1 health care assistant per practice) will participate in a workshop about polypharmacotherapy. The practice teams will create an individual concept which describes how they are planning to implement the recommendations into their practice. They will put their concept into practice and perform medication reviews and medication counselling for the included patients. Checklists, posters and flyers will be offered to them to facilitate implementation. Patients of the intervention group will complete an educational tool concerning medication-related topics on a tablet PC.

Patients and physicians of the control group will perform care as usual and will not receive any special training or information material.
Primary outcome measure(s) The degree of implementation of the three recommendations measured at patient level. The degree of implementation will be expressed by the number of indicators fulfilled per patient included in the study.
Secondary outcome measure(s) A comprehensive process evaluation will be performed including questionnaires for intervention fidelity and measures to evaluate the tailoring strategy.
Sources of funding European Union (EU) Framework 7 program, theme HEALTH.2013.3.1-1, grant agreement no 258837
Trial website
Publications 2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24308282
Contact name Prof  Joachim  Szecsenyi
  Address Department of General Practice and Health Services Research
Voßstraße 2, Geb. 37
  City/town Heidelberg
  Zip/Postcode 69115
  Country Germany
  Email joachim.szecsenyi@med.uni-heidelberg.de
Sponsor European Union (Netherlands)
  Address represented by the European Commission
Stichting Katholieke Universiteit
Comeniuslaan 4
  City/town Nijmegen
  Zip/Postcode 6525 HP
  Country Netherlands
  Email cornelia.jaeger@med.uni-heidelberg.de
Date applied 22/07/2013
Last edited 09/12/2013
Date ISRCTN assigned 14/08/2013
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