Study participation
Below you will find the most important information for GPs and pharmacists regarding participation in the PARTNER study.
Do you have questions about the study or are you interested in participating? Then please get in touch with the contact person of the respective study team, depending on the location.
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A GP practice forms a cooperation unit in each case with one or more pharmacies, which are randomly assigned to one of two study groups (A = PARTNER intervention or B = control intervention). The probability of being assigned to one of the two groups is equal.
- Regardless of the study group, each GP practice (with the support of the study team if necessary) identifies and recruits up to 15 patients who meet the inclusion criteria.
- Also independent of the study group, all participating patients attend an appointment at a pharmacy, where the patient's current medication is recorded (including those purchased over-the-counter) and checked for possible risks (such as side effects and drug interactions that could become relevant now or in the future).
In PARTNER intervention arm A, an approx. 2.5-hour workshop with case conference takes place before the appointment in the pharmacy, in which you participate together with your cooperating pharmacy. In the course of this workshop, you will receive further training on special aspects of multimedication and you will exchange information with the pharmacy about the patients included in the case conference. Participants in the intervention group will receive further details on intensified cooperation in advance in a specific training course.
- In control arm B, pharmacies cooperate with GP practices within the framework of routine care.
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Introduction to the study: We visit your practice at an agreed time and give you and your practice team an introduction. Afterwards, a member of the study team will work with your MFA to create a list of eligible patients using your practice management system. You then check the patients on this list for exclusion criteria. For this we plan about 1.5 hours with you, about 2 hours with your MFA. - You can watch the instruction video at any time.
- Patient recruitment: In the following 8 weeks, you will invite up to 15 of the patients identified in this way to the practice, inform them about the study and obtain their written consent.
- Data collection: We require medical information about the patients from you at three points in time (at the time of study inclusion and 6 and 12 months afterwards). Study staff will collect further study data directly from your study patients by telephone.
- If you are assigned to the intervention arm: You will take part in an approx. 2.5-hour case conference workshop in which you will discuss each patient with your PARTNER pharmacy. Participating patients will then have a discussion with the pharmacist and then a discussion with you. To record the results of the individual process steps, we use short questionnaires (answer in max. 5 minutes). Some of the participating doctors will also be invited to a more detailed telephone interview.
- If you are assigned to the control arm: There will be no further tasks for you.
The study team will support you in all study-related tasks wherever possible!
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If you are assigned to study group B (control arm), the following steps will apply:
- At the beginning of the study, the pharmacy will receive training (approx. 2 hours) in the conduct of the study and will be asked to nominate an administrative employee of the pharmacy as the main contact for the study team.
- For each participating patient, a registered pharmacist will update the medication regimen and conduct an interaction check and document it for study purposes. A feedback to the GP practice is done at your discretion (time required approx. 20 minutes).
- Documentation of further contacts with the study participants over a period of 12 months (10 minutes/patient).
If you are assigned to study arm A (intervention arm), the following additional steps will result:
- Participation in an approx. 2.5-hour workshop with the cooperating GP with a case conference and answering a short questionnaire (approx. 5 minutes).
- If applicable, participation in a further training course of the State Chamber of Pharmacists on medication analysis.
- Carrying out a medication analysis on the basis of patient information received from the doctor and a structured patient interview on selected problem medicines (approx. 1.5 hours/patient*). Identified drug-related problems will be documented for study purposes.
- Final interview with the study team, if invited (approx. 1.5 hours).
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By participating in the study, you have the opportunity to take part in industry-independent GP practice-based healthcare research on a highly relevant topic. The improvement of the cooperation between GP practices and pharmacies offers the opportunity for a meaningful division of labour in medication management and the option to relieve GP practices of this task in the future. In addition, you will gain access to further training and tools for the management of multi-medication and can strengthen the cooperation of your GP practice with pharmacies. After completion of the study, we will present the results to you.
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For GPs: In the intervention, specific GP activities such as medication review, adjustment and coordination with patients are used and supported with newly developed information and tools. This support helps to give you more decision-making confidence and therefore tends to reduce your professional risks in dealing with multi-medication.
For pharmacists: Participation in the study does not involve any risks for yourself. It may be that the GP decides to change the medication in consultation with the patient during the study. However, all clinical decisions (including all medication changes) are at the discretion of the GP, require the patient's consent and are not determined by the study protocol. In the event of adverse effects, medication changes may be reversed at the discretion of the GP and in consultation with the patient.
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If you are assigned to the control group, both GP practices and pharmacies will each receive an expense allowance of EUR 120 per included patient. If you are assigned to the PARTNER intervention group, you will receive an expense allowance of EUR 180 per included patient.