BSHs use among older patients Not Applicable
Conditions
Interventions
Cluster randomization
GPs who return the signed consent form will be randomized as clusters (more precisely: as cluster-defining units) to avoid contamination among their patients, and in batches to a
Sponsors
University of Zurich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Aged 65 years or older 2. Living at home or in a nursing home 3. Taking BSH for at least 2 weeks 4. Registred as a patient in the practice records of the recruiting GP 5. Willing to discuss their sleep and sleep behavior with their GP 6. Able to provide the relevant information required for the outcomes (e.g., rating on the quality of life scale) 7. Provided informed consent GPs: GPs from the German-speaking regions of Switzerland
Exclusion criteria
Exclusion criteria: Patients: 1. Life expectancy of less than 6 months 2. Incapability of judgement according to the clinical judgement of the GP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/05/2024: The percentage of patients who changed their BSH use (i.e., stopped, reduced, or switched to a non-BSH insomnia treatment) since their initial consultation (T0), measured at T1 (i.e., 6 months ± 3 weeks after T0). Definitions: 1. BSH: Drugs listed in the Anatomical Therapeutic Chemical (ATC) Classification System under code N05CD or code N05CF 2. Stopped: No consumption of any drug covered by codes N05CD or N05CF 3. Reduced: Reduction by at least 50% of the start dosage 4. Switched: Replacement of the previous BSH drug by a sleeping drug other than a BSH (as defined above) or by a non-pharmacological treatment for insomnia 5. T0: Immediately after the initial consultation, defined as the first consultation with a decision and plan of how to continue or discontinue the medication (intervention group) or how to go on with the care for the patient (control group). Possible preliminary consultations (e.g., to discuss study participation or to obtain informed consent) are disregarded. At T0, the GP or the MPA reports the patient’s BSH use – one of the inclusion criteria – on the Case Report Form (CRF). The BSH change will be reported on CRFs by the GP or the MPA at T1. T0 is set individually for each patient and relates to the time point after the initial consultation; the consecutive time points vary between patients accordingly. Previous primary outcome measure: The percentage of patients who changed their BSH use (i.e., stopped, reduced, or switched to a non-BSH insomnia treatment) since their initial consultation (T0), measured at T1 (i.e., 6 months after T0). Definitions: 1. BSH: Drugs listed in the Anatomical Therapeutic Chemical (ATC) Classification System under code N05CD or code N05CF 2. Stopped: No consumption of any drug covered by codes N05CD or N05CF 3. Reduced: Reduction by at least 50% of the start dosage 4. Switched: Replacement of the previous BSH drug by a sleeping drug other than a BSH (as defined abo | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 24/05/2024: 1. The percentage of patients willing to change their BSH use (i.e., stop, reduce or switch to a non-BSH insomnia treatment) at the end of the initial consultation T0. 2. The percentage of patients who do not accept the BSH deprescribing suggestion at the end of the initial consultation (T0). 3. Cumulative incidence between T0 and T1 of the following clinical events including utilization of healthcare: 3.1. Falls: 3.1.1. No Injury 3.1.2. Fracture, leading to 3.1.2.1. Ambulatory care (GP visit, emergency department (ED) visit) 3.1.2.2. Hospital stay 3.1.3. Other injury (excluding fractures), leading to 3.1.3.1. No utilization of healthcare 3.1.3.2. Ambulatory care (GP visit, ED visit) 3.1.3.3. Hospital stay 3.2. Other events: 3.2.1. Injury (not resulting from a fall): 3.2.1.1. No utilization of healthcare 3.2.1.2. Ambulatory care (GP visit, ED visit) 3.2.1.3. Hospital stay 3.2.2. Episode of anxiety (as perceived by the patient): 3.2.2.1. No utilization of healthcare 3.2.2.2. Ambulatory care (GP visit, ED visit) 3.2.2.3. Hospital stay 3.2.3. Episode of depression (as perceived by the patient): 3.2.3.1. No utilization of healthcare 3.2.3.2. Ambulatory care (GP visit, ED visit) 3.2.3.3. Hospital stay 3.2.4. Episode of confusion (as perceived by the patient): 3.2.4.1. No utilization of healthcare 3.2.4.2. Ambulatory care (GP visit, ED visit) 3.2.4.3. Hospital stay 3.2.5. Hospital stay not due to injury, fracture, anxiety or depression 3.2.6. Death (as a safety outcome) At each consultation between T0 and T1, the GPs or their MPAs will ask study patients about the above events and enter all reported events directly into a REDCap database at the study center via a dedicated online form. Additionally, at T1 (6 months ± 3 weeks after the initial consultation) a study nurse will contact the patients or, where applicable, their family members, by phone to collect data on events between T0 and T1. 4. Mean change in cognitive f | — |
Countries
Switzerland
Outcome results
None listed