- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283055
A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care (SINERGIC)
A Swiss Interprofessional Network for Reviewing Inappropriate Medication in Primary Care: a Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Step 1 (optional): Patients taking at least 10 chronic medications and experiencing adherence or side effect issues may benefit from a specialised consultation with a pharmacist.
- Step 2: The pharmacist identifies any medication-related issues for each patient and discusses them directly with the general practitioner in order to agree on the necessary adjustments.
- Step 3: During a medical appointment, the doctor and patient will decide together whether to implement the proposed changes.
- Step 4: The pharmacist will follow up after a few days and then again after 3 months.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland
- Institute of Primary Health Care (BIHAM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 65 years old;
- Regular use of at least 5 medications (chronic treatments, > 3 months);
- Patients with a minimum of 3 chronic diseases;
- Regular follow-up in a GP practice taking part in the project;
- Adequate understanding of French.
- Written informed consent
Exclusion Criteria:
- Residence in an institution (residential care facility, nursing home, etc.) ;
- Cognitive impairment preventing understanding or obtaining informed consent;
- Any other clinical situation deemed incompatible with participation, as decided by the GP in charge.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patient with medication review
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants recruited and percentage of participants retained
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
|
End of the study, expected to be on average after 4-6 months
|
|
Number of GPs recruited and percentage of GPs retained
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
|
End of the study, expected to be on average after 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost of the service
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.
|
During interprofessional meeting between GP and pharmacist
|
|
Score of participants' acceptability of the intervention (Patients Reported Experience Measures)
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
|
End of the study, expected to be on average after 4-6 months
|
|
Score of the healthcare professionals' acceptability of the intervention
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. |
End of the study, up to 18 months
|
|
Qualitative evaluation of healthcare professionals' acceptability
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 |
End of the study, up to 18 months
|
|
Number and percentage of clinically relevant drug related problems resolved
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.
|
3 months after medical consultation
|
|
Amount of drug cost savings
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.
|
3 months after medical consultation
|
|
Score on health-related quality of life (Patient-Reported Outcomes Measures or PROMs)
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 |
3 months after medical consultation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of DRPs identified
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 |
Evaluation of pharmacists clinical skills, End of the study, up to 18 months
|
|
Number and percentage of clinically relevant pharmaceutical interventions
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
|
Evaluation of pharmacists clinical skills, End of the study, up to 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Camille Lanfranchi, MSc, University of Bern (BIHAM)
- Study Chair: Juliane Fringeli, MSc, University of Bern (BIHAM)
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SINERGIC_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Care
-
University of EdinburghEnrolling by invitationPalliative Care | Primary Care | Primary Care PhysicianArgentina
-
McMaster UniversityUnknownPalliative Care | Satisfaction | Primary CareCanada
-
Duke UniversityCompleted
-
University of CoimbraCompletedPalliative Care | Primary Health CarePortugal
-
Bert LeysenIntermutualistic Agency; National Institute for Health and Disability Insurance...CompletedPalliative Care | Primary Health CareBelgium
-
University of Beira InteriorWithdrawnPalliative Care | Primary Health Care | GeriatricsPortugal
-
Veteran Affairs Office of Patient Care ServicesVA Office of Research and Development; VA Palo Alto Health Care System; VHA Primary...CompletedPrimary Health Care | Health Care Costs
-
VA Office of Research and DevelopmentVA Palo Alto Health Care System; Veteran Affairs Office of Patient Care ServicesCompletedPrimary Health Care | Health Care Costs
-
University of Colorado, DenverCompletedPrimary Health Care | Advance Care PlanningUnited States
-
Veteran Affairs Office of Patient Care ServicesVA Office of Research and Development; VA Palo Alto Health Care System; VHA Primary...CompletedPrimary Health Care | Health Care CostsUnited States
Clinical Trials on Medication review
-
Joke WuytsAssociation of Belgian Pharmacies (APB)Completed
-
Anne Estrup OlesenFrederikshavn Kommune, Frederikshavn, Denmark; Lægeklinikken Frederikshavn,...Completed
-
Diakonhjemmet HospitalUniversity of Oslo; Diakonhjemmet Hospital Pharmacy; Diakonhjemmet FoundationCompletedDrug-Related Side Effects and Adverse Reactions | Drug Interaction Potentiation | Medication Compliance | Remission | Medicinal Substance; Adverse EffectNorway
-
Psychiatric Research Unit, Region Zealand, DenmarkRegion Zealand; Steno Diabetes Center SjaellandCompletedPsychotic Disorders | Diabetes | Schizophrenia | Metabolic Syndrome | Bipolar Disorder | Major Depressive Disorder | Psychosis | Severe Mental DisorderDenmark
-
Geriatric Education and Research InstituteTan Tock Seng Hospital; Changi General HospitalCompletedMultimorbidity | Polypharmacy | Potentially Inappropriate MedicationsSingapore
-
Monash University MalaysiaCompleted
-
University of AarhusAarhus University HospitalCompleted
-
Odense University HospitalCompletedOlder Patients | Medication Review | Cross-sectional CommunicationDenmark
-
University of East AngliaCompleted