Institute of Primary Health Care (BIHAM)
Bern, Switzerland
NCT Number: NCT07283055
The aim of the SINERGIC pilot study is to assess the feasibility in the Swiss context of implementing interprofessional medication reviews between GP and pharmacists, as part of a shared decision-making process with patients. The acceptability and potential effectiveness of such an intervention will also be assessed.
This assessment will enable the investigators to take into account the determining factors for setting up a large-scale study to support the sustainable financing of this service in the long term.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Bern, Switzerland
The ageing population is leading to an increase in the prevalence of chronic conditions among older adults, often resulting in excessive polypharmacy. Polypharmacy, as well as the prescription of high-risk medications in this population, exposes them to more adverse effects, which can lead to falls and hospitalisation. This problem is of concern to healthcare professionals, whether they be general practitioners (GP), who have an overview of medical records, or dispensing pharmacists, who have an overview of medication. In Switzerland, these two professions still operate often in isolation from each other, but genuine collaboration is essential if we are to improve and manage polypharmacy among the elderly and limit the risks. Medication reviews are recognised as promising strategies for improving the quality of prescribing in patients with multiple medications.
This pilot trial does not randomly select participants and does not include a control group. It is a hybrid study that aims both to test the effectiveness of the intervention and to prepare for its implementation.
The study plans to include at least 250 patients from three groups of general practices in different settings. Participants will be aged 65 or older, take at least five chronic medications, and suffer from at least three chronic conditions. Individuals living in medical institutions will not be included.
Intervention:
Main objective: To assess whether this service is feasible in the context of the study.
Secondary objectives: Measure whether the intervention is well accepted (questionnaires and interviews) by the patients and healthcare professionals involved.
Exploratory objectives: Study the impact of the intervention on the quality of drug treatments, patients' quality of life and drug costs.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: End of the study, expected to be on average after 4-6 months
To assess the ability to recruit patients and retain patients for the duration of the follow-up and, if necessary, to explore the causes leading to their exit from the study; Measure: percentage
Time frame: End of the study, expected to be on average after 18 months
To assess the ability to recruit patients and retain patients for the duration of the follow-up and, if necessary, to explore the causes leading to their exit from the study; Measure: percentage
Time frame: End of the study, expected to be on average after 4-6 months
Patients' acceptability of the service is assessed using a questionnaire adapted from the Short Assessment of Patient Satisfaction (SAPS). This is a short, 6 to 7-item scale used to assess patients' perceptions of the effectiveness of their treatments, and can help identify ways of improving a practice or intervention and responding to patients' concerns. Scale from 1 to 5, with higher values representing higher acceptance
Time frame: End of the study, up to 18 months
GPs' acceptability of the service is assessed using an online questionnaire inspired by the Collaboration and Satisfaction About Care Decisions (CSACD) questionnaire and the Assessment of Interprofessional Team Collaboration Scale (AITCS-II). A 6-items scale from 1 to 5, with higher values representing higher acceptance
Additional semi-structured interviews based on a convenience sample will be conducted with health care professionals taking part to the main study by a trained student, in order to explore the conditions for implementing this new service in ambulatory care.
Time frame: End of the study, up to 18 months
Semi-structured interviews based on a convenience sample will be conducted with health care professionals taking part to the main study by a trained student, in order to explore the conditions for implementing this new service in ambulatory care.
Free text, qualitative analysis
Time frame: 3 months after medical consultation
The quality of medication therapy is assessed using a composite criterion based on five types of clinically relevant DRPs, taken from the recommendations of Beuscart et al. These DRPs will be documented using the validated PharmDisc tool adapted to our context. These DRPs reflect the appropriateness of prescribing. Their high frequency reflects poor prescribing quality. In order to standardise their identification, clinical pharmacists will be trained and using a protocol. PIMs will be identified according to the EU(7)-PIM list, which is a Europe-wide list.
Time frame: 3 months after medical consultation
Savings in drug costs (in CHF) calculated for medications that were modified following the medication review and maintained three months later. The cost difference will be estimated using the change in drug daily dose multiplied by the public price per unit.
Time frame: During interprofessional meeting between GP and pharmacist
Median cost of the intervention (in CHF) is calculated as the time invested by healthcare professionals (GPs, pharmacists) to conduct it multiplied by their average hourly wage.
Time frame: 3 months after medical consultation
PROMs will be collected using a questionnaire adapted from the iSIMPATHY project, incorporating the EQ-5D-5L. The questionnaire assesses several dimensions: mobility, usual activities, pain/discomfort, anxiety/depression, as well as the patient's priorities in relation to their medication. A convenience sample will be drawn up with a minimum of 10 patients per group of GP practices.
A five-items scale from 1 to 3, with higher values representing worst clinical outcomes
Time frame: Evaluation of pharmacists clinical skills, End of the study, up to 18 months
Number of DRPs identified comparatively to those identified by the expert panel.
Measure : percentage
Time frame: Evaluation of pharmacists clinical skills, End of the study, up to 18 months
Percentage of interventions clinically relevant evaluated by a panel of expert based on a standardised scale from 1 to 100, with higher values meaning best clinical relevance
University of Bern
Other
A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care: a Pilot Study
Acronym: SINERGIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05899114
Medication Review, Polypharmacy
Nijmegen, Gelderland, Netherlands
View Trial DetailsNCT07606716
Medication Review, Polypharmacy (People Under Treatment With 5 or More Drugs)
Woluwe-Saint-Lambert, Belgium
View Trial DetailsNCT06383364
Behavior, Empowerment
Aabenraa, Southern Denmark, Denmark
View Trial DetailsNCT06451692
Brain Diseases, Central Nervous System Diseases
Aabenraa, Southern Denmark, Denmark
View Trial Details