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

NCT05521971 | Completed

• 1 other identifier: S59134
• Study Type: interventional
• Target: 173
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypnotic Withdrawal

Keywords

deprescribing; tapering; adverse events; hypnotics; benzodiazepines; z-drugs; geriatrics

Outcome Measures

Primary Outcomes (1)

• Hypnotic drug discontinuation at one month after discharge

  Difference in hypnotic discontinuation rate between before and after group

  1 month after discharge

Secondary Outcomes (6)

• 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

  From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)

• Safety - incidence of delirium occurence during hospital stay

  From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)

• Sleep quality

  Upon inclusion, fourteen days after enrollment and one month after discharge

• Fall risk

  1 month after discharge

Study Arms (2)

Before group

OTHER

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

Other: Usual care group

After group

EXPERIMENTAL

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

Interventions

multifaceted pharmacist-led intervention 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.

After group

Usual care group 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.

Before group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Related Publications (3)

• 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.

  PMID: 11868796 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 37400758 DERIVED

Study Officials

• Jos Tournoy, Prof

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before-after study

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 30, 2022
• Study Start: October 11, 2016
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share