Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001128189
Ethics application status
Approved
Date submitted
1/08/2019
Date registered
12/08/2019
Date last updated
3/10/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate if providing vape as a smokefree support product to service users in an acute inpatient mental health unit is acceptable to both service users and staff.
Scientific title
Feasibility, acceptability and impact on agitation and aggression of providing nicotine vaporisers in a closed Adult Mental Health Service unit.
The eCIMUS study (Use of electronic Cigarettes in Inpatient Mental health service Users who Smoke)
Secondary ID [1] 298833 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
eCIMUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute mental health disorder 313788 0
Condition category
Condition code
Mental Health 312194 312194 0 0
Addiction
Mental Health 312195 312195 0 0
Anxiety
Mental Health 312196 312196 0 0
Depression
Mental Health 312197 312197 0 0
Psychosis and personality disorders
Mental Health 312198 312198 0 0
Schizophrenia
Mental Health 312199 312199 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. The smokefree support treatments provided in acute inpatient unit (Tiaho Mai):
First line smoke-free support: standard smoking cessation support (Nicotine Replacement Product) with an appropriate dose according to service user's daily cigarette consumption;
with a second line smoke-free support: E-liquid using a nicotine vaporiser.
Consented service users (study participants) can choose to have either the second line smoke-free support or the combination of both first and second line smoke-free supports.

2. The procedure:
The study nurse will administer a vaping device to all consented service users eligible for vaping who:
o are confirmed by a nurse that they are a smoker
o have given consents to take part in the study
o decline NRT offered according to the Counties Manukau Health Management of Nicotine Dependence inpatients and other hospital visitors who smoke guideline, or find that NRT alone is insufficient.
o are requesting a tobacco cigarette.

Study participants will be provided with a nicotine vaporiser (with e-liquid cartridges) on request, during the duration of the trial. Patients will be taught how to use the product and will be given the e-liquid cartridges in the enclosed unit and take the vape in the open courtyard (~30 square meters) of the enclosed unit of Tiaho Mai.

The nicotine vaporiser and e-liquid (containing nicotine salt) will be supplied by Myriad NZ and will be the ‘Alt. Pod Kit. The e-liquid will be Alt. E-liquid with the Gold tobacco favour (40mg) which is formulated to the standards by Myriad Laboratories in the ISO7 clean room in NZ.
All products will be free to the service user and labelled with the participant’s name. The duration of vaping time will be limited to 5 min (this will give service users ~ 10-13 puffs each time) and the total amount of nicotine per day will also be limited to not more than 120mg. If participant choose to have the combination of both NRP and e-cigarette, the total amount of nicotine of each day will also be limited to a safe amount. This is to prevent excessive accumulated amount taken by some patients.

All clinicians who will be involved in the study will be trained by the smokefree support committee members in the use of the nicotine vaporiser and e-liquid cartridges so they can support service users to use the product.

Medication monitoring: Participants’ medication will be monitored at a case-by-case manner. The consumed amount of e-liquid will be approximated using the residuals from the cartridge. This will provide information of the approximated nicotine consumption. Any patient who consumes a high amount of nicotine will be checked and their medication will be closely monitored.
When people leave the Kimi Whanaungatanga ward, patients will be given information on how to procure the nicotine vaporiser. They can also take the vaporiser after being discharged to the community services and carry on using the product with refill provided by the smokefree committee if they wish.










Intervention code [1] 315102 0
Prevention
Intervention code [2] 315247 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320827 0
Level of agitation measured using the DYNAMIC APPRAISAL OF SITUATIONAL AGGRESSION INPATIENT VERSION (DASA) tool
Timepoint [1] 320827 0
Daily DASA score in the standard clinical assessment time (and two additional assessments before and after the first request of vape) will be administrated. The assessment starts from patient admitted until discharge or 4 weeks post-intervention commencement.
Primary outcome [2] 320828 0
Staff reported number of physical assaults, will be collected from standard clinical incidence reports.
Timepoint [2] 320828 0
Daily from admission to the inpatient unit until discharge or 4 weeks post-intervention commencement.
Secondary outcome [1] 372975 0
Aggressive behaviour, will be collected from routine incidence report (including routinely collected data on smoking-related incidents including restraint/seclusion).
Timepoint [1] 372975 0
Daily from admission to the inpatient unit until discharge or 4 weeks post-intervention commencement.
Secondary outcome [2] 372984 0
Acceptability of the intervention, will be assessed using a survey including a visual analogue acceptability score.
Timepoint [2] 372984 0
One month after the participant's admission
Secondary outcome [3] 372985 0
Uptake of the product, will be measured by the number of the vaping request per day, amount of e-liquid consumed.
Timepoint [3] 372985 0
Daily from admission to the inpatient unit until discharge or 4 weeks post-intervention commencement.
Secondary outcome [4] 372986 0
Staff acceptability, will be assessed in an interview.
Timepoint [4] 372986 0
At the end of the study
Secondary outcome [5] 373691 0
Safety outcome 1: Any adverse effects caused by vape and vaping
Timepoint [5] 373691 0
Daily from admission to the inpatient unit until discharge or 4 weeks post-intervention commencement.
Secondary outcome [6] 373692 0
Safety outcome 2: the number of physical assaults reported in the enclosed ward caused by vaping
Timepoint [6] 373692 0
Daily from admission to the inpatient unit until discharge or 4 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
1. Inclusion criteria for patients:
Patients in the closed unit (Kimi Whanaungatanga ward) of the adult inpatient mental health unit - Tiaho Mai at Counties Manukau Health (CMH) who self-reports they smoke at admission or are confirmed by a nurse that they are a smoker (if they are not too unwell to self-report at the time of admission).
2. Inclusion criteria for staff:
Staff members who are willing to learn to use vaping product and can demonstrate how to use it for service users.




Staff who are consented to participate the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients: nonsmokers, patients without the capacity to consent (i.e. dementia, intellectually impaired and require high dependent guardians), and pregnant women.

Staff: Staff members who are not willing to learn and teach service users how to use vaping product. Staff member who are allergic to vape.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It is open label, non-randomized, uncontrolled feasibility study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
It is a feasibility study
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All qualitative data will be analysed using the general inductive methods for qualitative data analysis. The feasibility study provides important information for the design parameters around practicality. These information will assess the acceptability of nicotine vaporise to acute mental health patients and staff working in acute mental health wards. The information curated will include:
• Standard deviation of the outcome measure, which is needed in some cases to estimate sample size,
• Willingness of participants to be participated,
• Willingness of clinicians to recruit participants,
• number of eligible patients,
• characteristics of the proposed outcome measure and other potential outcome measure,
• follow-up rates, response rates to questionnaires, adherence/compliance rates
• intervention delivery and tracking; safety monitoring processes for safety outcomes
.
• All qualitative data will be analysed thematically using the general inductive method for qualitative data analysis (Thomas, 2008).
• Quantitative data will be analysed using simple descriptive statistics. The degree of agitation will be determined using DASA scores as routinely recorded on the ward. Change in DASA score from baseline will be derived. Any decrease in DASA score from baseline would be considered a reduction in agitation. A lower than average number of reported smoking-related incidents (including fewer seclusion and restraints) would be considered a decrease in aggressive behaviour. The data collection sheets will be analysed by the researchers at the end of one week to identify any issues that need to be changed, and again at the end of four weeks. The acceptability of vaping to service users will be determined using data from the data collection sheet. Acceptability will be indicated by the number of nicotine vaporisers administered or e-liquid used each day and measured by an acceptability score.
• Safety outcome analysis : Adverse effect of vaping and the number of physical assaults reported in the enclosed ward caused by vaping, will be summarised for study participants.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2019
Actual
Date of last participant enrolment
Anticipated
15/03/2020
Actual
Date of last data collection
Anticipated
15/04/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 21712 0
New Zealand
State/province [1] 21712 0
Auckland

Funding & Sponsors
Funding source category [1] 303382 0
Hospital
Name [1] 303382 0
Middlemore Hospital
Country [1] 303382 0
New Zealand
Primary sponsor type
Government body
Name
Counties Manukau Health
Address
Middlemore Hospital
100 Hospital Road,
Private Bag 93311,
Otahuhu,
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 303422 0
None
Name [1] 303422 0
Address [1] 303422 0
Country [1] 303422 0
Other collaborator category [1] 280868 0
University
Name [1] 280868 0
University of Auckland
Address [1] 280868 0
School of Population Health,
Faculty of Medical and Health Sciences,
The University of Auckland
Private Bag 92019, Auckland 1142, NEW ZEALAND
Country [1] 280868 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303914 0
New Zealand Health Disability and Ethics Committee
Ethics committee address [1] 303914 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 303914 0
New Zealand
Date submitted for ethics approval [1] 303914 0
15/08/2019
Approval date [1] 303914 0
01/10/2019
Ethics approval number [1] 303914 0
19/CEN/166

Summary
Brief summary
Project summary

• Rationale: In New Zealand, as elsewhere, people with mental health problems have a very high prevalence of tobacco smoking. If people with serious mental illness enter a closed inpatient mental health service, New Zealand law requires that they become smoke-free - that is, they are not permitted to smoke cigarettes in the unit. However, it is not uncommon for service users to experience nicotine withdrawal and become agitated and aggressive if they are unable to smoke. Such behaviour may adversely affect their management and pose a risk to staff and other inpatients. Typically, service users are offered nicotine replacement therapy (NRT) to help manage the symptoms of cigarette withdrawal. However, many service users decline the offer of NRT or they find NRT as an alternative self-medicine is insufficient. One option to address this issue is to offer service users who smoke and request a cigarette, a substitute product, specifically electronic nicotine vaporisers (also referred to as vapes or e-cigarettes), either as an alternative to NRT or as an adjunct to NRT.
• Aims: To determine (i) the feasibility of offering nicotine vaporisers to service users of a closed ward in a mental health unit who usually smoke tobacco, as substitutes for cigarettes, when they request a cigarette and decline offers of NRT, or find NRT alone insufficient; (ii) the acceptability of nicotine vaporisers to service users and staff in a closed ward; and (iii) the effect of nicotine vaporisers on incidents arising from agitation and aggressive behaviour in this patient population.
• Hypotheses:
(i) Nicotine vaporisers will be feasible to introduce into a closed mental health unit (ii) Nicotine vaporisers will be acceptable to both service users of a closed ward and clinical staff at the mental health unit; and (iii) the use of nicotine vaporisers will result in fewer incidents related to agitation and aggressive behaviour.
• Method and analysis:
Design: A prospective, open, non-randomised, uncontrolled feasibility study intervention. The total duration of the study will be 6 -12 months.
Participants: Participants will be people who are service users admitted to the closed unit (Kimi Whanaungatanga ward) in the adult (>18 years of age) inpatient mental health unit Tiaho Mai at Counties Manukau Health (CMH), who are confirmed by a study nurse to be a current smoker (defined as smoking at least one cigarette a day), give consent to participate in the study, decline NRT or find NRT alone to be insufficient, and are requesting a tobacco cigarette.
Intervention: Consented patients will be offered standard NRT treatment in appropriate dose for their level of dependency (as the first line medication support) and provided with a nicotine vaporiser in appropriate intensity (as a second line product support).

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95230 0
Dr Coni Kalinowski
Address 95230 0
Tiaho Mai, Mental health and addiction service,
Middlemore Hospital,
100 hospital road,
Private Bag 93311,
Auckland 1640
Country 95230 0
New Zealand
Phone 95230 0
+6492760044
Fax 95230 0
Email 95230 0
coni.Kalinowski@middlemore.co.nz
Contact person for public queries
Name 95231 0
Dr Irene Suilan Zeng
Address 95231 0
Colvin Complex Level 1/Mental health and addiction Service,
Middlemore hospital
100 hospital road,
Private Bag 93311
Otahuhu, Auckland 1640
Country 95231 0
New Zealand
Phone 95231 0
+6492760044
Fax 95231 0
Email 95231 0
irene.zeng@middlemore.co.nz
Contact person for scientific queries
Name 95232 0
Prof Chris Bullen
Address 95232 0
School of Population Health,
Faculty of Medical and Health Sciences,
The University of Auckland
Private Bag 92019, Auckland 1142, NEW ZEALAND
Country 95232 0
New Zealand
Phone 95232 0
+6493737999
Fax 95232 0
Email 95232 0
c.bullen@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.