Clinical trial NCT05521971: The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients
Official title: The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients: a Before-after Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnotic Withdrawal
Keywords: deprescribing
tapering
adverse events
hypnotics
benzodiazepines
z-drugs
geriatrics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 173
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: before-after study
Primary purpose: PREVENTION

Brief summary: This study investigated whether a multifaceted approach was associated with hypnotic drug discontinuation at one month after discharge

Detailed description: Chronic use of hypnotic agents is prevalent in older adults, who as a result are at increased risk for certain adverse events, such as day-time drowsiness and falls. Multiple strategies to discontinue hypnotics have been tested in geriatric patients, but evidence remains scarce. Hence, we aimed to investigate a multicomponent intervention to reduce hypnotic drug use in geriatric inpatients.

A before-after study was performed on the acute geriatric wards of a teaching hospital. The before cohort received usual care while intervention patients were exposed to a pharmacist-led deprescribing intervention, comprising education of health care personnel, access to standardized discontinuation regimens, active patient involvement and support of transitional care. The primary outcome was hypnotic drug discontinuation at one month after discharge.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 75 years
* Admitted to an acute geriatric ward of UZ Leuven
* Documented chronic use of a hypnotic drug (hypnotics were defined as benzodiazepines and Z-drugs and chronic hypnotic drug use was defined as hypnotic use for at least five days a week during a minimum of four consecutive weeks.
* Indication: insomnia, anxiety or an undefined reason

Exclusion Criteria:

* Concomitant use of multiple benzodiazepines and/or Z-drugs
* Discontinuation of the hypnotic drug prior to enrollment
* Estimated discharge from the hospital within 72 hours of admission
* No command of the Dutch language
* Severe psychiatric or neurological disease (e.g. bipolar disorder, epilepsy or dystonia) or a severe acute medication condition in the opinion of the treating physician
* End-of-life care.

Study participants who died during their hospital stay were excluded from the analysis as their medication at discharge could not be evaluated. In case of any readmission, only the first admission was included in the analysis.

Primary outcomes:
measure: Hypnotic drug discontinuation at one month after discharge
timeFrame: 1 month after discharge
Secondary outcomes:
measure: Hypnotic drug use
timeFrame: 1 and 2 weeks after enrollment and at discharge (the end of the hospital stay, on average 12 days after admission)
measure: Restart of hypnotics during hospital stay
timeFrame: From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)
measure: Safety - incidence of delirium occurence during hospital stay
timeFrame: From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)
measure: Sleep quality
timeFrame: Upon inclusion, fourteen days after enrollment and one month after discharge
measure: Fall risk
timeFrame: 1 month after discharge
measure: Determinants for post-discharge hypnotic discontinuation
timeFrame: 1 month after discharge
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jos Tournoy, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petrovic M, Pevernagie D, Mariman A, Van Maele G, Afschrift M. Fast withdrawal from benzodiazepines in geriatric inpatients: a randomised double-blind, placebo-controlled trial. Eur J Clin Pharmacol. 2002 Jan;57(11):759-64. doi: 10.1007/s00228-001-0387-4.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.