Study "hype" on the topic of sleeping pills and tranquilizers

Switzerland (ICTRP)

ICTRP Studien-ID
ISRCTN34363838 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Impact of a deprescribing tool on sedative hypnotics use among older patients: A cluster-randomized controlled trial in Swiss primary care (the HYPE trial) (BASEC)

Wissenschaftlicher Titel
The impact of a deprescribing tool on sedative hypnotics use among older patients: a cluster-randomized controlled trial in Swiss primary care (the HYPE trial) (ICTRP)

Öffentlicher Titel
Deprescribing sedative hypnotics among older patients in Swiss primary care (ICTRP)

Untersuchte Krankheit(en)
BSHs use among older patients
Not Applicable (ICTRP)

Untersuchte Intervention
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 avoid delays for already included GPs due to slow recruitment. Batchwise covariate-constrained randomization of the GPs will take place whenever the required number of participants for an even number of training sessions has been reached. The additional allocation constraint, that all GPs of the same (group) practice be allocated to the same study group (thus forming ?superclusters? of clusters), will help prevent contamination between GPs. Randomization will be done by an independent third party at the Institute of Primary Care, Zurich, with the help of a computerized randomization calculator. A list of the intervention group participants and the control group participants will be stored and created at the institute. GPs will remain blinded with regard to their allocation.

Patient allocation
All patients will be allocated to their recruiting GP?s study group without further randomization and will be part of her/his cluster. The resulting cluster effect at the GPs level is statistically corrected during data analysis. All patients are blinded to their cluster's assignment to the intervention or control group.

The intervention is a 1-hour online training on how to use the two-part patient support tool (including decision-making guidance, a tapering schedule and non-pharmaceutical alternative treatments for insomnia) for GPs. Additionally, the intervention group GPs (including their medical practice assistants [MPAs]) will attend a 30-minute online instruction on data acquisition (study measurements).

The control group GPs will participate in a 1-hour online training cour (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Prospective two-arm double-blinded cluster-randomized controlled trial (Other) (ICTRP)

Ein-/Ausschlusskriterien
Gender: Both
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 (ICTRP)

Exclusion criteria: Patients:
1. Life expectancy of less than 6 months
2. Incapability of judgement according to the clinical judgement of the GP

Primäre und sekundäre Endpunkte
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. (ICTRP)

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) (ICTRP)

Registrierungsdatum
13.04.2023 (ICTRP)

Einschluss des ersten Teilnehmers
31.05.2023 (ICTRP)

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
nicht verfügbar

Sekundäre IDs
Nil known, Nil known, Nil known (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
Available on requestThe study results will be published in an international peer-reviewed journal and at national medical conferences. (ICTRP)

Weitere Informationen zur Studie
https://www.isrctn.com/ISRCTN34363838 (ICTRP)