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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with medication review | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication review | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants recruited and percentage of participants retained | 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 | End of the study, expected to be on average after 4-6 months |
| Number of GPs recruited and percentage of GPs retained | 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 | End of the study, expected to be on average after 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score of participants' acceptability of the intervention (Patients Reported Experience Measures) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of DRPs identified | Number of DRPs identified comparatively to those identified by the expert panel. Measure : percentage | Evaluation of pharmacists clinical skills, End of the study, up to 18 months |
| Number and percentage of clinically relevant pharmaceutical interventions |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camille Lanfranchi, MSc | University of Bern (BIHAM) | Study Chair |
| Juliane Fringeli, MSc | University of Bern (BIHAM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Primary Health Care (BIHAM) | Bern | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17630042 | Background | Mallet L, Spinewine A, Huang A. The challenge of managing drug interactions in elderly people. Lancet. 2007 Jul 14;370(9582):185-191. doi: 10.1016/S0140-6736(07)61092-7. | |
| 32365168 | Background | Liew TM, Lee CS, Goh SKL, Chang ZY. The prevalence and impact of potentially inappropriate prescribing among older persons in primary care settings: multilevel meta-analysis. Age Ageing. 2020 Jul 1;49(4):570-579. doi: 10.1093/ageing/afaa057. |
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Once fully anonymized, quantitative data will be annotated and structured to make them sharable, and registered in a FAIR-compliant data repository.
Since now until 5 years after study completion
on Demand (to main authors)
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| ID | Term |
|---|---|
| D000090143 | Medication Review |
| ID | Term |
|---|---|
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
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Pilot trial; Before/after comparison
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| End of the study, expected to be on average after 4-6 months |
| Score of the healthcare professionals' acceptability of the intervention | 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. | End of the study, up to 18 months |
| Qualitative evaluation of healthcare professionals' acceptability | 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 | End of the study, up to 18 months |
| Number and percentage of clinically relevant drug related problems resolved | 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. | 3 months after medical consultation |
| Amount of drug cost savings | 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. | 3 months after medical consultation |
| Cost of the service | 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. | During interprofessional meeting between GP and pharmacist |
| Score on health-related quality of life (Patient-Reported Outcomes Measures or PROMs) | 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 | 3 months after medical consultation |
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 |
| Evaluation of pharmacists clinical skills, End of the study, up to 18 months |
| 37818791 | Background | Cole JA, Goncalves-Bradley DC, Alqahtani M, Barry HE, Cadogan C, Rankin A, Patterson SM, Kerse N, Cardwell CR, Ryan C, Hughes C. Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev. 2023 Oct 11;10(10):CD008165. doi: 10.1002/14651858.CD008165.pub5. |