Hello deprescribing world! Today we have another guest blog post by Dr. Jean-Pascal Fournier and Dr. Jerome Nguyen from Nantes University in France. Today, they will tell us about a deprescribing study they are currently working on.
The department of general practice of Nantes University (France) is a team of primary care researchers, with deprescribing as a priority research topic. We would like to introduce to you our Proton Pump Inhibitor (PPI) deprescribing trial that should begin next fall in two French departments.
1- Joining academic and stakeholder forces for a PPI deprescribing trial in primary care
Designing this trial has been an 18-month intensive collaboration between us and our local Caisse Primaire d’Assurance Maladie (CPAM, French health insurance system), with whom we have a great history of successive partnerships. Aligning our academic expertise on deprescribing with the CPAM priorities on safe prescribing, we agreed that there was a need for a PPI deprescribing program. In France, PPIs are one of the most commonly used medications in primary care and are mostly prescribed by general practitioners (GPs). Given their important potential for adverse drug reactions and their cost, PPIs were targeted for a massive deprescribing intervention, in primary care.
2- Adapting existing intervention materials to France and producing a new patient education material
The next step required to design the intervention was harnessing work from previous studies that demonstrated effective multifaceted deprescribing interventions. Based on previous international trials, we concluded that a joint intervention focusing on both patients and prescribers would provide greater effectiveness. The CPAM already has the ability to reach both patients and prescribers, which is a great asset for us to reach our aims.
There are a lot of deprescribing materials out there directed to GPs and we identified several deprescribing algorithms through evidence mapping. Our team used AGREE II to assess the different algorithms and found that the algorithm developed by deprescribing.org performed best. We got in touch with its development team and had it adapted to a French context.
Developing the patient education material was more challenging. We first conducted a focused review of existing patient education materials, followed by an evaluation of their suitability to our target population (using the Suitability Assessment of Materials tool). We decided to develop our very own education material to address the shortcomings of existing patient education materials: lowering the reader’s required level of reading (as deprescribing should target patients that are often aged and/or with low literacy), avoiding usage of negative images (such as warnings references or lists of side effects), and gaining on patient stimulation (e.g. adding more illustrations to draw attention). We followed the development guidelines proposed by the French health authorities and tested the education material with patients using questionnaires and semi-structured interviews.
Our main intervention is a joint intervention: sending education materials to long-term PPI users and sending the algorithms to their GPs. This intervention will be compared to a single intervention on GPs only, and to a control group (no intervention). Each of these three groups will be approximately 10,000 patients and 500 GPs. They will be followed for a year after the intervention.
3- Choosing the right outcomes
In conducting a real-world trial, we faced the challenge of choosing the right outcomes. We needed to balance the feasibility of the trial with a global assessment that would encompass the perspectives of everyone: patients, stakeholders, and researchers. After repeated team meetings, we agreed to primarily focus on discontinuation of PPIs, as proxied with the CPAM reimbursement database. We added secondary outcomes that would help us gain insight on the efficacy of our intervention. We plan to send questionnaires through post to 10% of targeted patients, and assess their changes in quality of life (allowing to conduct a cost-effectiveness analysis), the possibility of a rebound acid reflux, and their attitudes towards deprescribing (to explore its associations with the success of our intervention).
Developing the protocol of this trial has been the core of Jerome Nguyen’s Master thesis. We had the chance to have this trial quickly funded through a national grant. This trial has not started yet, but to us, it is already a success. The start of the trial is planned for next fall, with the first results expected in early 2022. We are looking forward to sharing the results of this exciting project with you.
Photo Credit: Olga Khabarova on Unsplash.