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

NCT ID: NCT05521971

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-11

Study Completion Date

2019-09-19

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypnotic Withdrawal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

before-after study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Before group

In the usual care cohort, there was no systematic clinical pharmacist involvement regarding deprescribing of hypnotics.

Group Type OTHER

Usual care group

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

multifaceted pharmacist-led intervention

Intervention Type OTHER

* 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jos Tournoy, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

References

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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.

Reference Type BACKGROUND
PMID: 11868796 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

Van der Linden L, Hias J, Liesenborghs A, Walgraeve K, Van Brantegem P, Hellemans L, Milisen K, Tournoy J. The impact of a pharmacist intervention on post-discharge hypnotic drug discontinuation in geriatric inpatients: a before-after study. BMC Geriatr. 2023 Jul 4;23(1):407. doi: 10.1186/s12877-023-04139-y.

Reference Type DERIVED
PMID: 37400758 (View on PubMed)

Other Identifiers

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S59134

Identifier Type: -

Identifier Source: org_study_id

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