Implementing recommendations for Polypharmacotherapy of multimorbid Patients (PomP)

ISRCTN	ISRCTN34664024
DOI	https://doi.org/10.1186/ISRCTN34664024
Secondary identifying numbers	European Union EU Framework 7 program, theme HEALTH.2013.3.1-1, grant agreement no 258837

Submission date: 22/07/2013
Registration date: 14/08/2013
Last edited: 08/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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?
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?
November 2013 to June 2014

Who is funding the study?
European Union

Who is the main contact?
Dr Cornelia Jäger
Cornelia.jaeger@med.uni-heidelberg.de

Contact information

Prof Joachim Szecsenyi
Scientific

Department of General Practice and Health Services Research
Voßstraße 2, Geb. 37
Heidelberg
69115
Germany

Email	joachim.szecsenyi@med.uni-heidelberg.de

Study information

Study design	6 months cluster randomized controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A tailored implementation intervention to implement recommendations addressing Polypharmacotherapy of multimorbid Patients (PomP): study protocol of a cluster-randomized controlled trial
Study acronym	PomP
Study objectives	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(s)	Ethical approval pending from the Ethical Review Committee of the University of Heidelberg, Germany
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2013
Completion date	01/06/2014

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	40 primary care practices, 1000 patients
Key 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).
Key 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.
Date of first enrolment	01/11/2013
Date of final enrolment	01/06/2014

Locations

Countries of recruitment

Germany

Study participating centre

Department of General Practice and Health Services Research

Heidelberg
69115
Germany

Sponsor information

European Union (Netherlands)
Government

represented by the European Commission
Stichting Katholieke Universiteit
Comeniuslaan 4
Nijmegen
6525 HP
Netherlands

Email	cornelia.jaeger@med.uni-heidelberg.de
"ROR"	https://ror.org/019w4f821

Funders

Funder type

Government

Seventh Framework Programme, theme HEALTH.2013.3.1-1, grant agreement no 258837
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 date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/12/2013	Yes	No
Results article	results	13/01/2017	Yes	No
Other publications	process evaluation	06/03/2017	Yes	No

Editorial Notes

08/03/2017: Publication reference added.
16/01/2017: Publication reference added.