Deprescribing sedative hypnotics among older patients in Swiss primary care

Approved 04/04/2023, Kantonale Ethikkommission Zürich (Stampfenbachstrasse 121, Zurich, 8090, Switzerland; +41 (0)43 259 79 70; admin.kek@kek.zh.ch), ref: 2023-00054

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 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.

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 function level measured using Six Item Screener (SIS), The Trail Making Test Part A (TMT-A) between T0 and T1
5. Mean change in depressive symptoms measured using Depression in Old Age Scale (DIA-S) between T0 and T1
6. Mean change in subjective sleep quality measured using Insomnia Severity Index (ISI) between T0 and T1
7. Mean change in anxiety symptoms measured using Generalized Anxiety Disorder Scale-7 (GAD-7) between T0 and T1
8. Mean change in the quality of life (QoL) measured using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) between T0 and T1
9. Attitudes, beliefs, barriers, and facilitators among GPs and patients assessed using questionnaires, telephone interviews at T2 for GPs (14 months ± 3 weeks after the initial consultation of a GP’s first patient) and at T1 for patients (6 months ± 3 weeks after the patient’s initial consultation)
10. Process evaluation measurements among GPs of the intervention group and their patients using questionnaires, telephone interviews at T2 for GPs (14 months ± 3 weeks after the initial consultation of a GP’s first patient) at T1 for patients (6 months ± 3 weeks after the patient’s initial consultation)




Previous secondary outcome measure:
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 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 function level measured using Six Item Screener (SIS), The Trail Making Test Part A (TMT-A) between T0 and T1
5. Mean change in depressive symptoms measured using Depression in Old Age Scale (DIA-S) between T0 and T1
6. Mean change in subjective sleep quality measured using Insomnia Severity Index (ISI) between T0 and T1
7. Mean change in anxiety symptoms measured using Generalized Anxiety Disorder Scale-7 (GAD-7) between T0 and T1
8. Mean change in the quality of life (QoL) measured using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) between T0 and T1
9. Attitudes, beliefs, barriers, and facilitators among GPs and patients assessed using questionnaires, telephone interviews at T2 for GPs (14 months after the initial consultation of a GP’s first patient) and at T1 for patients (6 months after the patient’s initial consultation)
10. Process evaluation measurements among GPs of the intervention group and their patients using questionnaires, telephone interviews at T2 for GPs (14 months after the initial consultation of a GP’s first patient) at T1 for patients (6 months after the patient’s initial consultation)