Condition category
Not Applicable
Date applied
22/07/2013
Date assigned
14/08/2013
Last edited
09/12/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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 20–25 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Joachim Szecsenyi

ORCID ID

Contact details

Department of General Practice and Health Services Research
Voßstraße 2
Geb. 37
Heidelberg
69115
Germany
joachim.szecsenyi@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

European Union EU Framework 7 program, theme HEALTH.2013.3.1-1, grant agreement no 258837

Study information

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

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.

Ethics approval

Ethical approval pending from the Ethical Review Committee of the University of Heidelberg, Germany.

Study design

6 months cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Implementation of recommendations for polypharmacotherapy in multimorbid patients

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

A comprehensive process evaluation will be performed including questionnaires for intervention fidelity and measures to evaluate the tailoring strategy.

Overall trial start date

01/11/2013

Overall trial end date

01/06/2014

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

40 primary care practices, 1000 patients

Participant 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.

Recruitment start date

01/11/2013

Recruitment end date

01/06/2014

Locations

Countries of recruitment

Germany

Trial participating centre

Department of General Practice and Health Services Research
Heidelberg
69115
Germany

Sponsor information

Organisation

European Union (Netherlands)

Sponsor details

represented by the European Commission
Stichting Katholieke Universiteit
Comeniuslaan 4
Nijmegen
6525 HP
Netherlands
cornelia.jaeger@med.uni-heidelberg.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

European Union (EU) Framework 7 program, theme HEALTH.2013.3.1-1, grant agreement no 258837

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

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24308282

Publication citations

  1. Protocol

    Jäger C, Freund T, Steinhäuser J, Joos S, Wensing M, Szecsenyi J, A tailored implementation intervention to implement recommendations addressing polypharmacy in multimorbid patients: study protocol of a cluster randomized controlled trial., Trials, 2013, 14, 420, doi: 10.1186/1745-6215-14-420.

Additional files

Editorial Notes