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Completed

NCT Number: NCT05521971

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

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

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Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Hypnotic drug discontinuation at one month after discharge

    Time frame: 1 month after discharge

    Difference in hypnotic discontinuation rate between before and after group

Secondary outcomes

  1. Hypnotic drug use

    Time frame: 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

  2. Restart of hypnotics during hospital stay

    Time frame: 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.

  3. Safety - incidence of delirium occurence during hospital stay

    Time frame: 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

  4. Sleep quality

    Time frame: 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

  5. Fall risk

    Time frame: 1 month after discharge

    The occurrence of falls

  6. Determinants for post-discharge hypnotic discontinuation

    Time frame: 1 month after discharge

    Factors associated with hypnotic discontinuation

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.