The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients

Not Applicable

Completed

• Conditions: Hypnotic Withdrawal
• Interventions: Other: multifaceted pharmacist-led intervention; Other: Usual care group

• Registration Number: NCT05521971
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2016-10-11
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Status Verified: 2022-08
• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
After group	multifaceted pharmacist-led intervention	In the intervention cohort a pharmacist-led intervention was implemented comprising the four following components: 1) education of health care personnel; 2) access to standardized discontinuation regimens; 3) patient education; 4) support of transitional care.
Before group	Usual care group	In the usual care cohort, there was no systematic clinical pharmacist involvement regarding deprescribing of hypnotics.

Primary Outcome Measures

Name	Time	Method
Hypnotic drug discontinuation at one month after discharge	1 month after discharge	Difference in hypnotic discontinuation rate between before and after group

Secondary Outcome Measures

Name	Time	Method
Restart of hypnotics during hospital stay	From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)	The emergency use of hypnotics after any discontinuation attempt during hospital stay.
Sleep quality	Upon inclusion, fourteen days after enrollment and one month after discharge	Sleep quality was determined during a patient interview using the Pittsburgh Sleep Quality Index (PSQI). The PSQI concerns a validated questionnaire where a higher score signifies a worse sleep quality; a total score of 5 or more indicates poor sleep quality
Safety - incidence of delirium occurence during hospital stay	From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)	During hospital stay the incidence of physician-identified delirium was assessed together with emergency use of antipsychotics
Fall risk	1 month after discharge	The occurrence of falls
Hypnotic drug use	1 and 2 weeks after enrollment and at discharge (the end of the hospital stay, on average 12 days after admission)	Description of type and dose of hypnotic drug use
Determinants for post-discharge hypnotic discontinuation	1 month after discharge	Factors associated with hypnotic discontinuation