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

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

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

Study Overview

• Status: Completed
• Conditions: Hypnotic Withdrawal
• Intervention / Treatment: Other: Usual care group; Other: multifaceted pharmacist-led intervention

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 Type: Interventional
• Enrollment (Actual): 173
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Before group; In the usual care cohort, there was no systematic clinical pharmacist involvement regarding deprescribing of hypnotics.	Other: Usual care group; all patients received comprehensive geriatric care without any systematic clinical pharmacist involvement regarding deprescribing of hypnotics. Treating physicians were not actively informed on the patient's participation in this particular study.
Experimental: After group; 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.	Other: multifaceted pharmacist-led intervention; Educational sessions were provided to the physicians and nursing staff.; Discontinuation regimens were developed. Prescribers were free to choose whether or not to actually use them. The regimens were derived from the regimen used by Petrovic et al. and encouraged a switch from any benzodiazepine to lorazepam 1 mg OD for one week followed by drug stop. Z-drugs were switched to zolpidem 5 mg OD for one week followed by drug stop. If deemed necessary, a pro re nata regimen of lorazepam 1 mg or zolpidem 5 mg for one additional week was prescribed respectively. The discontinuation regimens were incorporated into the hospital's electronic prescribing system. Furthermore, a clinical decision support system provided additional support.; Patient education sessions were provided upon enrolment and at discharge. Specific patient leaflets were used to facilitate patient education.; The patient's primary care physician and, if applicable, the nursing home were informed by phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypnotic drug discontinuation at one month after discharge	Difference in hypnotic discontinuation rate between before and after group	1 month after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypnotic drug use	Description of type and dose of hypnotic drug use	1 and 2 weeks after enrollment and at discharge (the end of the hospital stay, on average 12 days after admission)
Restart of hypnotics during hospital stay	The emergency use of hypnotics after any discontinuation attempt during hospital stay.	From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)
Safety - incidence of delirium occurence during hospital stay	During hospital stay the incidence of physician-identified delirium was assessed together with emergency use of antipsychotics	From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)
Sleep quality	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	Upon inclusion, fourteen days after enrollment and one month after discharge
Fall risk	The occurrence of falls	1 month after discharge
Determinants for post-discharge hypnotic discontinuation	Factors associated with hypnotic discontinuation	1 month after discharge

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Jos Tournoy, Prof, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): September 19, 2019
• Study Completion (Actual): September 19, 2019

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: deprescribing; tapering; adverse events; hypnotics; benzodiazepines; z-drugs; geriatrics
• Other Study ID Numbers: S59134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Only upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No