Hypnotic WithdrawalNCT05521971
The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients
A study testing multifaceted pharmacist-led intervention in people with Hypnotic Withdrawal, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
This study investigated whether a multifaceted approach was associated with hypnotic drug discontinuation at one month after discharge Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hypnotic Withdrawal
- What is being tested?
- multifaceted pharmacist-led intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2016to 19 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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
Read the 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.
- Conditions
- Hypnotic Withdrawal
- Being tested
- multifaceted pharmacist-led intervention, Usual care group
- Keywords
- deprescribing, tapering, adverse events, hypnotics, benzodiazepines, z-drugs, geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multifaceted pharmacist-led interventionOther
- 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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Before group | Other | In the usual care cohort, there was no systematic clinical pharmacist involvement regarding deprescribing of hypnotics. Receives: 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. Receives: Other: multifaceted pharmacist-led intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypnotic drug discontinuation at one month after discharge
Difference in hypnotic discontinuation rate between before and after group
Measured: 1 month after discharge
Secondary outcomes (6)
Hypnotic drug use
Description of type and dose of hypnotic drug use
Measured: 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.
Measured: 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
Measured: 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
Measured: Upon inclusion, fourteen days after enrollment and one month after discharge
Fall risk
The occurrence of falls
Measured: 1 month after discharge
Determinants for post-discharge hypnotic discontinuation
Factors associated with hypnotic discontinuation
Measured: 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start11 Oct 2016
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypnotic WithdrawalStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- before-after study
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jos Tournoy, Prof, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521971
- Sponsor's protocol ID
- S59134
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only upon reasonable request
Publications
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.
PubMed 11868796Buysse 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.
PubMed 2748771Van 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.
PubMed 37400758
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Pharmacist Intervention on Post-discharge Hypnotic Drug Discontinuation in Geriatric Inpatients: a Before-after Study
- ClinicalTrials.gov ID
- NCT05521971
- Acronym / sponsor ID
- S59134
- Conditions
- Hypnotic Withdrawal
- Keywords
- deprescribing, tapering, adverse events, hypnotics, benzodiazepines, z-drugs, geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- before-after study
| Arm | Type | Receives |
|---|---|---|
| Before group | Other | Other: Usual care groupIn the usual care cohort, there was no systematic clinical pharmacist involvement regarding deprescribing of hypnotics. |
| After group | Experimental | Other: multifaceted pharmacist-led interventionIn 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | After group |
| Usual care groupall 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. | Other | Before group |
Primary outcome
Hypnotic drug discontinuation at one month after discharge
Time frame: 1 month after discharge
Difference in hypnotic discontinuation rate between before and after group
6 secondary outcomes
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)
Restart of hypnotics during hospital stay
Time frame: From enrollment until discharge (the end of the hospital stay, on average 12 days after admission)
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)
Sleep quality
Time frame: Upon inclusion, fourteen days after enrollment and one month after discharge
Fall risk
Time frame: 1 month after discharge
Determinants for post-discharge hypnotic discontinuation
Time frame: 1 month after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 11868796Petrovic 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.
- Background: PubMed 2748771Buysse 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.
- Derived from this study: PubMed 37400758Van 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.
- Individual participant dataSharing planned: No. Only upon reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jos Tournoy, Prof principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing multifaceted pharmacist-led intervention in people with Hypnotic Withdrawal, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypnotic drug discontinuation at one month after discharge (time frame: 1 month after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.