None listed
Conditions
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).
Interventions
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
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.
Sponsors
Counties Manukau Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed