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Trial registered on ANZCTR


Registration number
ACTRN12623001294640
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
12/12/2023
Date last updated
12/12/2023
Date data sharing statement initially provided
12/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Stop Smoking, Start Living (S3L) project
Scientific title
Evaluation of the Stop Smoking, Start Living (S3L) project in hospital patients who are identified as smokers
Secondary ID [1] 309571 0
Nil
Universal Trial Number (UTN)
Trial acronym
S3L
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 329874 0
Quitting smoking 329875 0
Condition category
Condition code
Public Health 326781 326781 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A clinician behaviour intervention (CBI) will increase sustained use of a multifaceted evidence-based intervention (“bundle”) targeting smokers from general and High-Risk Populations. Elements of the bundle are:
1. Brief counselling
2. Nicotine Replacement Therapy (NRT)
3. A text messaging program (TMP)

S3L Implementation staff are asked to complete the NSW Health HETI smoking cessation module (https://www.heti.nsw.gov.au/education-and-training/courses-and-programs/smoking-cessation-a-guide-for-all-staff). This is the standard default module provided to NSW health staff and covers the approach to counselling and NRT. This material was developed by HETI/NSW Health and has been adopted as current practice by the project.

1. Brief counselling
Brief smoking cessation counselling is included in the intervention bundle as per NSW Health Smoke-free Health Care Policy PD2015_003. Specific counselling guidelines are as per My Health Learning Module Smoking cessation: a guide for staff, which details the 5As approach. The Smoking Cessation 5As is a guide to a once-off interaction that should take place at least once with each admitted patient ( https://www.health.nsw.gov.au/tobacco/Factsheets/tool-2-guide-5as.pdf).
S3L aims to endorse and increase staff compliance with Policy PD2015_003. S3L does not set any specific quotas in terms of duration and frequency of 5As counselling, rather, any extent to which staff engages with smoking cessation practices is encouraged and supported.

2. NRT
NRT is offered by ward staff to eligible patients as per NSW Health directive. Staff are directed to offer NRT in line with three NSW Health Tools for Assessing Nicotine Dependence and NRT prescription (https://www.health.nsw.gov.au/tobacco/Factsheets/tool-3-assessing-nicotine.pdf, https://www.health.nsw.gov.au/tobacco/Factsheets/tool-4-nrt-in-hospital.pdf and https://www.health.nsw.gov.au/tobacco/Factsheets/tool-5-quick-guide-nrt.pdf).

For patients who smoke, this involves having their nicotine dependence assessed by a health care professional, if clinically appropriate being offered NRT, and if accepted, the relevant NRT product/s charted and administered as part of their inpatient medications. The duration and frequency of the therapy is as deemed clinically appropriate by the medical team. Usually, nicotine patches are prescribed once every 24hour period, while oral NRT products are often provided to the patient as Po Re Nata (PRN) . To support longer term access to NRT on discharge, patients are offered at least three days’ supply of the NRT product/s they received during admission, as well as a PBS prescription if applicable (applies to Nicotine Patches only).

3. TMP
Ward staff inform patients who smoke of a new quit support TMP and sign them up to it if they are interested in receiving the messages. Registered patients receive 120 messages over 12 weeks. An example of a text message is: "If you're feeling a bit sick when using your NRT, you might be swallowing too much nicotine from lozenges. Try resting it more in the side of your mouth." The full library can be viewed on request. Recipients cannot respond to messages but there is the option to opt-out in each text. The system allows for tracking of enrolment and opt-outs.

4. Tc
TRANSLATE- cessation (Tc) is a 3-month program offered to implementation leads (ILs) that includes the provision of evidence-based tailored training and support materials, regular online training and coaching sessions as well as a support team based at UNSW that is available during business hours.

Tc aims to upskill ILs to support adoption of the S3L intervention within their organisation. ILs are NSW Health staff who are already employed within the respective Local Health Districts, in either clinical (e.g. nurse) or non-clinical (e.g. Health Promotion Officers) roles. Support provided to ILs by the project team is through Microsoft Teams and email correspondence, as well as by their respective S3L District Leads.

Phase 1: Recruitment of Implementation Teams
ILs are supported to recruit ward staff as part of their Implementation Team on intervention wards with resources such as informative handouts, presentation slides, and email templates. The exact IL recruitment process depends on local factors such as familiarity with ward staff and ward engagement and support.

Phase 2: Engagement with Implementation Teams
ILs organise three (~1 hour) meetings with their Implementation teams and a fourth meeting with the Nurse Unit Manager (~30 minutes) to co-design and prepare for the S3L intervention. Prior to each meeting, a coaching session held by the project team on Microsoft Teams aims to prepare ILs for the upcoming Implementation team meeting. Implementation Team meetings are held online or in-person depending on team preference.

Phase 3: Rollout of S3L
The roll out of S3L occurs once implementation staff are training but is a variable process depending on ward specific factors such as IL availability, ward engagement and preferences. Digital resources are provided to ILs to support implementation, including a Smoking Cessation Tool (SCT) which is made available electronically and as hardcopy.
Intervention code [1] 325998 0
Behaviour
Comparator / control treatment
Wards that are not receiving the CBI
Control group
Active

Outcomes
Primary outcome [1] 334634 0
The proportion of patient records with smoking status recorded (either smoker/ non-smoker) in the eMR, by hospital ward, over time. Data on smoking status will be extracted from the hospital coding database collected for administrative purposes.
Timepoint [1] 334634 0
6 months post intervention
Secondary outcome [1] 421467 0
Time series data of the rate at which staff record smoking status in eMR during hospital admission. Data on smoking status will be extracted from the hospital databases used to collect coding data for administrative purposes.
Timepoint [1] 421467 0
End of trial
Secondary outcome [2] 427973 0
Semi-structured interviews will be used to explore the qualitative experience of patients from HRPs. Questions will cover the themes of smoking behaviours, intentions or attempts to quit smoking, and perceptions of smoking cessation support. Data will be analysed thematically using NVivo to assess this outcome.
Timepoint [2] 427973 0
3-6 months post intervention implementation
Secondary outcome [3] 427974 0
Effect of Tc on health care professional behaviour measured by extracting smoking status-related data from hospital administrative databases and NRT prescribing data recorded in eMR.
Timepoint [3] 427974 0
3-6 months post intervention implementation

Eligibility
Key inclusion criteria
All patients from selected wards who have been identified as smokers in eMR on intervention wards
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Need to be able to read and understand PICS.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes allocation was concealed; central randomisation is completed by an external party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313759 0
Government body
Name [1] 313759 0
NSW Government Department of Health
Country [1] 313759 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
Locked Mail Bag 21Taren Point NSW 2229
Country
Australia
Secondary sponsor category [1] 315582 0
University
Name [1] 315582 0
University of New South Wales
Address [1] 315582 0
High StreetKensington New South Wales 2052
Country [1] 315582 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312930 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312930 0
District Executive Unit, Level 4The Sutherland Hospital & Community Health ServiceCnr The Kingsway and Kareena RoadCARINGBAH NSW 2229
Ethics committee country [1] 312930 0
Australia
Date submitted for ethics approval [1] 312930 0
02/11/2022
Approval date [1] 312930 0
16/02/2023
Ethics approval number [1] 312930 0

Summary
Brief summary
NSW Health smoking cessation policy is evidence-based, yet poorly implemented. We are funded to roll out a TRANSLATE (TRAining in evideNce-baSed ImpLementATion for hEalth) (TRANSLATE- cessation (Tc) implementation intervention in randomly selected hospital wards of three LHDs as part of a quality assurance activity.
Random selection aims to distribute limited resources in a fair manner and provides an opportunity to examine the efficacy of the Stop Smoking Start Living (S3L) bundle in intervention (Tc + S3L) versus control wards. The qualitative experience of patients from high-risk populations (HRPs) in intervention wards will be examined. HRPs include women who smoke during pregnancy, people with mental illness, people with diagnoses of drug and alcohol abuse/dependence and Aboriginal and Torres Strait Islander people.
Sub-studies include:
1. Effect of Tc on health care professional behaviour.
2. Effect of Tc and S3L on patient smoking behaviour.
3. Qualitative experience of HRPs with the S3L treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126378 0
A/Prof Patrick Bolton
Address 126378 0
South Eastern Sydney Local Health DistrictPrince of Wales HospitalHigh StRandwick NSW 2031
Country 126378 0
Australia
Phone 126378 0
+61 418152152
Fax 126378 0
Email 126378 0
patrick.bolton@health.nsw.gov.au
Contact person for public queries
Name 126379 0
A/Prof Patrick Bolton
Address 126379 0
South Eastern Sydney Local Health DistrictPrince of Wales HospitalHigh StRandwick NSW 2031
Country 126379 0
Australia
Phone 126379 0
+61 418152152
Fax 126379 0
Email 126379 0
patrick.bolton@health.nsw.gov.au
Contact person for scientific queries
Name 126380 0
A/Prof Patrick Bolton
Address 126380 0
South Eastern Sydney Local Health DistrictPrince of Wales HospitalHigh StRandwick 2031
Country 126380 0
Australia
Phone 126380 0
+61 418152152
Fax 126380 0
Email 126380 0
patrick.bolton@health.nsw.gov.au

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.