Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001227886
Ethics application status
Approved
Date submitted
6/07/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot evaluation of a novel smoking cessation training program for South Australian Health Professionals.
Scientific title
Pilot evaluation of feasibility of a novel smoking cessation training program for South Australian Health Professionals.
Secondary ID [1] 303878 0
Nil known.
Universal Trial Number (UTN)
U1111-1267-6592
Trial acronym
Linked study record
This record is a nested sub-study of study: ACTRN12620001223921.

Health condition
Health condition(s) or problem(s) studied:
Tobacco smoking 321450 0
Condition category
Condition code
Public Health 319215 319215 0 0
Health promotion/education
Public Health 319216 319216 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Health Professionals (HP) in the intervention arm will complete a 35-minute 'Standardised Training' session (workshop), the semi-structured format is as follows:
• Smoking cessation training: 15 minutes
• Smoking cessation practice: 10 minutes
• Introduction to healthcare barriers: 10 minutes

Each of the Standardised Training sessions will be conducted by the Coordinating Principal Investigator (CPI).

Smoking cessation training
Participate in the 15-minute best practice evidence-based training designed by the Cancer Council Australia. Training covers the ‘Ask, Advise, Help’ model as described below:
• Ask: HPs ask patients about their smoking status,
• Advise: HPs advise patients to quit and, jointly with the smoker, identifies the best way of doing this, and,
• Help: HPs offer practical support to patients who communicated an interest in stopping smoking through referral to Quitline and initiates request to Doctor to provide appropriate medication review.

Smoking cessation practice
Participate in a 10-minute practice session during which the CPI will review and reinforce appropriate technique. On completion of the session, HPs will be provided with existing South Australian Cancer Council SA smoking cessation resources.

Introduction to healthcare barriers
Watch a 10-minute pre-recorded video developed by an Aboriginal Cultural Awareness consultant that focuses on:
• The diversity of Aboriginal cultural and language groups in South Australia,
• The barriers to accessing health services,
• How healthcare services are conceived, and,
• Training in practical actions that HPs can take to improve the provision of Aboriginal health services.

Health professionals in the intervention arm will also be trained to use Kick the Smokes resources developed during ACTRN12620001223921 This will occur immediately after, and in the same session as their 'Standardised Training'. This includes:

• KTS quit smoking materials (workbook), and
• KTS AR smartphone application,
• KTS Health Professional materials (penholder and poster).

This additional semi-structured training will be delivered by the CPI during an additional 25-minute training session.

KTS AR smartphone application
This smartphone App has been co-designed with feedback from Aboriginal participants and HPs. Loaded on the participants’ (Aboriginal patient, or HP) phone it accesses the camera, and when held over select items in the workbook, digital content appears on the screen. The content differs depending on which image the camera is catching.

KTS booklet on smoking cessation
An A3 sized booklet co-designed with feedback from Aboriginal participants this booklet has been designed to distract and occupy smokers when they are experiencing cravings.

KTS Health Professional materials
These materials are provided to HPs as reminders of the smoking cessation counselling training they’ve received.

Following completion of their training participants will then be directed to use their new skills as part of their standard practice going forward.

KTS resource dissemination
Following completion of the training by HPs, resources will be provided to HPs for implementation of the smoking cessation tools in the community. They will receive five workbooks, one poster and one penholder. As part of their training they will be shown how to download the App. They will also be directed to use their new skills as part of their standard practice over the remainder of the practice (which will include the 3-month follow-up period).

Monitoring
Project staff will complete a review form at the end of each workshop and cultural responsiveness session to record session implementation data. Each review will be retained by project staff for collation and data entry. Data will be examined, and resultant descriptive statistics will be reported narratively.
Intervention code [1] 320182 0
Behaviour
Comparator / control treatment
Health Professionals in the control arm will complete the same 35-minute 'Standardised Training' session as the intervention cohort; the semi-structured format is as follows:
• Smoking cessation training: 15 minutes
• Smoking cessation practice: 10 minutes
• Introduction to healthcare barriers: 10 minutes

Each of the Standardised Training sessions will be conducted by the Coordinating Principal Investigator (CPI). The total duration of this training is 35 minutes.

Smoking cessation training
Participate in the 15-minute best practice evidence-based training designed by the Cancer Council Australia. Training covers the ‘Ask, Advise, Help’ model as described below:
• Ask: HPs ask patients about their smoking status,
• Advise: HPs advise patients to quit and, jointly with the smoker, identifies the best way of doing this, and,
• Help: HPs offer practical support to patients who communicated an interest in stopping smoking through referral to Quitline and initiates request to Doctor to provide appropriate medication review.

Smoking cessation practice
Participate in a 10-minute practice session during which the CPI will review and reinforce appropriate technique. On completion of the session, HPs will be provided with existing South Australian Cancer Council SA smoking cessation resources.

Introduction to healthcare barriers
Watch a 10-minute pre-recorded video developed by an Aboriginal Cultural Awareness consultant that focuses on:
• The diversity of Aboriginal cultural and language groups in South Australia,
• The barriers to accessing health services,
• How healthcare services are conceived, and,
• Training in practical actions that HPs can take to improve the provision of Aboriginal health services.

Participants in this arm will not receive the KTS resources (KTS APP, workbook and professional materials) or training.

Following completion of their training HPs will be directed to use their new skills as part of their standard practice over the remainder of the practice (which will include the 3-month follow-up period).

Monitoring
Project staff will complete a review form at the end of each workshop and cultural responsiveness session to record session implementation data. Each review will be retained by project staff for collation and data entry. Data will be examined, and resultant descriptive statistics will be reported narratively.
Control group
Active

Outcomes
Primary outcome [1] 327084 0
The extent to which the Kick the Smokes (KTS) smoking cessation training reached Health professionals (HPs) as measured by the proportion of eligible HPs that attended the smoking cessation training as assessed through an audit of project data records,
Timepoint [1] 327084 0
At baseline (day of training delivery).
Primary outcome [2] 327085 0
The extent to which the study specific questionnaire capture differences in HP behaviours using the ProSCITE smoking cessation evaluation tool through an audit of HPs responses to questions within their study specific questionnaires.
Timepoint [2] 327085 0
At baseline (day of training delivery), and one-month and three-months from the date of training delivery.
Primary outcome [3] 327086 0
The extent to which the study specific questionnaire accurately captured Aboriginal patient attitude as measured by the number of Aboriginal patients completing all questions within their surveys.
Timepoint [3] 327086 0
At 3-months from the date of training delivery.
Secondary outcome [1] 393720 0
The extent to which the KTS cultural responsiveness training reached HPs as measured by the proportion of HPs that attended cultural responsiveness training as assessed through an audit of project data records,
Timepoint [1] 393720 0
Within 3-months from the date of training delivery.
Secondary outcome [2] 393721 0
The extent to which the resources reached Aboriginal patients as measured by the proportion of HPs who took ‘KTS’ or Cancer Council SA resources as assessed through an audit of project data records,
Timepoint [2] 393721 0
At 3-months from the date of training delivery.
Secondary outcome [3] 393722 0
Ability to recruit the target number of HPs within the duration of the study as measured by the number of eligible HPs that attended ‘KTS’ smoking cessation training as assessed through an audit of project data records.
Timepoint [3] 393722 0
At 3-months from the date of training delivery.
Secondary outcome [4] 393723 0
Ability to recruit the target number of Aboriginal Patients within the duration of the study as measured by the number of eligible Aboriginal Patients seen within the study duration as recorded on study specific Health Professional questionnaires.
Timepoint [4] 393723 0
At one-month and three-months from the date of training delivery.
Secondary outcome [5] 393724 0
Effectiveness of the ‘KTS’ smoking cessation training program at improving HP offers of quit smoking support as measured by the number of HPs reporting change per ProSCiTE domain question.
Timepoint [5] 393724 0
At 3-months from the date of training delivery.
Secondary outcome [6] 393725 0
Effectiveness of the ‘KTS’ training program at helping Aboriginal patients to quit as measured by the number of Aboriginal patients self-reporting smoking cessation as a result of the counselling session with a trained HP as recorded in their study specific questionnaire.
Timepoint [6] 393725 0
Within 3-months from the date of training delivery.
Secondary outcome [7] 393726 0
How effective was the ‘KTS’ workbook at helping Aboriginal patients to quit as measured by
self-reported smoking cessation of Aboriginal consumers as a result of the KTS workbook as reported on their study specific questionnaires.
Timepoint [7] 393726 0
Within 3-months from the date of training delivery.
Secondary outcome [8] 393727 0
How effective was the ‘KTS’ App at helping Aboriginal patients to quit as measured by the number of Aboriginal consumers self-reporting smoking cessation of as a result of using the ‘KTS’ App as recorded in their study specific questionnaire.
Timepoint [8] 393727 0
Within 3-months from the date of training delivery.
Secondary outcome [9] 393732 0
The extent to which ‘KTS’ was adopted by HPs as measured by the number of ‘KTS’ or Cancer Council SA resources that were given out by each Health Professional as reported on their study specific questionnaire,
Timepoint [9] 393732 0
At 3-months from the date of training delivery.
Secondary outcome [10] 393733 0
The extent to which Aboriginal patients adopted the ‘KTS’ workbooks as measured by the
degree of ‘KTS’ workbook adoption reported on their study specific questionnaire.
Timepoint [10] 393733 0
At 3-months from the date of training delivery.
Secondary outcome [11] 393734 0
The extent to which Aboriginal patients engaged with the ‘KTS’ augmented reality content as measured by the proportion of handout material reported to have been given out compared to the number of unique smartphone users who logged into the App as assessed from study specific questionnaires and App analytic data respectively,
Timepoint [11] 393734 0
At 3-months from the date of training delivery.
Secondary outcome [12] 393735 0
How consistently implemented was each ‘KTS’ smoking cessation workshop as measured by the average length of time and range for each ‘KTS’ smoking cessation workshop in total as assessed through an audit of project records,
Timepoint [12] 393735 0
At 1-month from the date of training delivery.
Secondary outcome [13] 393736 0
How consistently implemented was each cultural responsiveness workshop as measured by the average length of time and range for each cultural responsiveness workshop in total as assessed through an audit of project records.
Timepoint [13] 393736 0
At 3-months from the date of training delivery.
Secondary outcome [14] 393737 0
How consistently delivered was each offer of quit smoking support by HPs as measured by the proportion of HPs giving ‘KTS’ or Cancer Council SA resources to Aboriginal patients as reported on their study specific questionnaires.
Timepoint [14] 393737 0
At 1 and 3-months from the date of training delivery.
Secondary outcome [15] 393738 0
How consistent was resource interaction by Aboriginal patients as measured by the average length of time and range each workbook was used per Aboriginal consumer in total as reported on their study specific questionnaire.
Timepoint [15] 393738 0
At 3-months from the date of training delivery.
Secondary outcome [16] 393747 0
What changes were made to facilitate easier implementation of the training or ‘KTS’ or Cancer Council SA resource delivery as assessed through an audit of project data records.
Timepoint [16] 393747 0
At 1-month from the date of training delivery.
Secondary outcome [17] 393749 0
Were offers of smoking support to Aboriginal patients maintained in frequency over time as measured by the proportion of HPs offering quit smoking support to Aboriginal patients from baseline compared with each follow-up period as reported in their study specific questionnaire
Timepoint [17] 393749 0
At 3-months from the date of training delivery.
Secondary outcome [18] 393750 0
Were offers of resources from HPs to Aboriginal patients maintained in frequency over time as measured by the proportion of HPs offering demonstrations of the ‘KTS’ or Cancer Council SA resources to Aboriginal patients from baseline compared to each follow-up period as reported in their study specific questionnaire.
Timepoint [18] 393750 0
At baseline (day of training delivery), and one-month and three-months from the date of training delivery.
Secondary outcome [19] 393754 0
Was Aboriginal patient use of the App maintained over time, as measured by
change in the frequency of Aboriginal consumer App usage over time as assessed by App analytic data.
Timepoint [19] 393754 0
At 3-months from the date of training delivery.
Secondary outcome [20] 398831 0
Was Aboriginal patient use of the App maintained over time, as measured by change in the duration of Aboriginal consumer App usage per section over time as assessed by App analytic data.
Timepoint [20] 398831 0
At 3-months from the date of training delivery.
Secondary outcome [21] 398833 0
Was Aboriginal patient use of the App maintained over time, as measured by change in the duration of Aboriginal consumer overall App usage over time as assessed by App analytic data.
Timepoint [21] 398833 0
At 3-months from the date of training delivery.
Secondary outcome [22] 398835 0
How consistent was resource interaction by Aboriginal patients as measured by the average length of time and range each section of the workbook was used per Aboriginal consumer as reported on their study specific questionnaire.
Timepoint [22] 398835 0
At 3-months from the date of training delivery.
Secondary outcome [23] 398836 0
How consistent was resource interaction by Aboriginal patients as measured by the average length of time and range Cancer Council SA resources were used per Aboriginal consumer in total as reported on their study specific questionnaire.
Timepoint [23] 398836 0
At 3-months from the date of training delivery.
Secondary outcome [24] 398837 0
How consistent was resource interaction by Aboriginal patients as measured by the average length of time and range each section of the Cancer Council SA resources were used per Aboriginal consumer as reported on their study specific questionnaire.
Timepoint [24] 398837 0
At 3-months from the date of training delivery.
Secondary outcome [25] 398838 0
How consistently delivered was each offer of quit smoking support by HPs as measured by the proportion of HPs demonstrating the App to their Aboriginal patient as reported on their study specific questionnaire.
Timepoint [25] 398838 0
At 1 and 3-months from the date of training delivery.
Secondary outcome [26] 398839 0
How consistently implemented was each cultural responsiveness workshop as measured by the average length of time and range for each section of the cultural responsiveness workshop as assessed through an audit of project records.
Timepoint [26] 398839 0
At 3-months from the date of training delivery.
Secondary outcome [27] 398840 0
How consistently implemented was each ‘KTS’ smoking cessation workshop as measured by the average length of time and range for each section of the ‘KTS’ smoking cessation workshop as assessed through an audit of project records.
Timepoint [27] 398840 0
At 1-month from the date of training delivery.
Secondary outcome [28] 398841 0
The extent to which Aboriginal patients engaged with the ‘KTS’ augmented reality content as measured by the degree of App adoption as reported on their study specific questionnaires.
Timepoint [28] 398841 0
At 3-months from the date of training delivery.
Secondary outcome [29] 398842 0
The extent to which Aboriginal patients engaged with the ‘KTS’ augmented reality content as measured by the proportion of unique smartphone users who logged into the App multiple times compared to those who logged in once as assessed by App analytic data,
Timepoint [29] 398842 0
At 3-months from the date of training delivery.
Secondary outcome [30] 398843 0
The extent to which Aboriginal patients adopted the ‘KTS’ workbooks as measured by the number of Aboriginal patients who reported that they had used at least one part of the ‘Kick the Smokes’ workbook as reported on their study specific questionnaires.
Timepoint [30] 398843 0
At 3-months from the date of training delivery.
Secondary outcome [31] 398844 0
The extent to which ‘KTS’ was adopted by HPs as measured by the reasons for HPs offering or not offering quit smoking support to Aboriginal patients as reported on their study specific questionnaires.
Timepoint [31] 398844 0
At 1 and 3-months from the date of training delivery.
Secondary outcome [32] 398845 0
The extent to which ‘KTS’ was adopted by HPs as measured by the proportion of Aboriginal patients who were offered support to quit smoking by the HP compared to the number of unique ‘KTS’ App users as assessed by the Aboriginal patients study specific survey and App analytic data.
Timepoint [32] 398845 0
At 3-months from the date of training delivery.
Secondary outcome [33] 398846 0
The extent to which ‘KTS’ was adopted by HPs as measured by the reasons for HPs disseminating or not disseminating ‘KTS’ or Cancer Council SA resources as recorded in their study specific questionnaire.
Timepoint [33] 398846 0
At 1 and 3-months from the date of training delivery.
Secondary outcome [34] 398849 0
Effectiveness of the ‘KTS’ App at helping Aboriginal patients to quit as measured by the number of Aboriginal consumers reporting overall positive compared to negative opinions about the App as an approach to help with quit attempts as measured on the 5 star scale included in their study specific questionnaire.
Timepoint [34] 398849 0
Within 3-months from the date of training delivery.
Secondary outcome [35] 398855 0
Effectiveness of the ‘KTS’ workbook at helping Aboriginal patients to quit as measured by the number of Aboriginal consumers reporting overall positive compared with negative opinions about the workbook as an approach to help with quit smoking attempts as reported on their study specific questionnaires
Timepoint [35] 398855 0
Within 3-months from the date of training delivery.
Secondary outcome [36] 398856 0
Effectiveness of the ‘KTS’ training program at helping Aboriginal patients to quit as measured by the number of Aboriginal consumers reporting offers of quit smoking support by HPs as recorded in their study specific questionnaire.
Timepoint [36] 398856 0
At 3-months from the date of training delivery.
Secondary outcome [37] 398857 0
Effectiveness of the ‘KTS’ smoking cessation training program at improving HP offers of quit smoking support as measured by the range of HPs reported change for each ProSCiTE domain question.
Timepoint [37] 398857 0
At 3-months from the date of training delivery.
Secondary outcome [38] 398859 0
The extent to which the Kick the Smokes (KTS) smoking cessation training reached Health professionals (HPs) as measured by the number of eligible HPs that attended ‘KTS’ smoking cessation training as assessed through an audit of project data records,
Timepoint [38] 398859 0
At baseline (day of training delivery).
Secondary outcome [39] 398862 0
The extent to which the Kick the Smokes (KTS) smoking cessation training reached Health professionals (HPs) as measured by the profession type of HPs who participated in the smoking cessation training as assessed through an audit of project records,
Timepoint [39] 398862 0
At baseline (day of training delivery).
Secondary outcome [40] 398863 0
The extent to which the Kick the Smokes (KTS) smoking cessation training reached Health professionals (HPs) as measured by the reasons for non-attendance as assessed through an audit of project records.
Timepoint [40] 398863 0
At baseline (day of training delivery).

Eligibility
Key inclusion criteria
Health Professional inclusion criteria:
1. Health Professionals (defined as a Specialist medical officer; Trainee medical office; Advanced trainee; Allied Health Professional; Nurse; Registrar; Aboriginal Liaison Officer, other), working within the participating cluster hospitals,
2. Have access to Aboriginal Inpatients classified as smokers at ward level,
3. Available time to participate in study with approval from Head of Unit to participate.

Aboriginal Patient inclusion criteria:
1. Identify as either Aboriginal and/or Torres Strait islander,
2. Current Inpatient within participating hospital unit,
3. “Regular smoking of tobacco products, including manufactured (packet) cigarettes, roll-your-own cigarettes, cigars and pipes, but excluding chewing tobacco and the smoking of non-tobacco products […]” (ABS, 2017),
4. Able to read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health Professional exclusion criteria:
1. Employed as agency staff working across CALHN hospital units.
2. Participation in ongoing professional education (smoking cessation and/or cultural responsiveness).

Aboriginal Patient exclusion criteria:
1. Current participation in a smoking research study, or,
2. Aged under 18 years of age.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central randomisation by coin-toss.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Randomisation will occur at the hospital level, Health Professionals (HPs) within these hospitals will therefor participate in either the intervention or control training cohorts. Aboriginal Patients will not be randomised, their access tot he KTS resources is dependent on the allocation of their consulting HP; that is; patients of HPs from the intervention cohort will receive the KTS resources; patients of HPs from the control cohort will not receive these resources.

As noted this CRCT is nested within a larger feasibility study. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework will be used to assess feasibility of the study. Primary and secondary outcomes developed in accordance with this framework and analytical approach are detailed herein. These outcomes will be used to determine whether the study method can be successfully upscaled to a operate as a larger, full-scale, CRCT. The feasibility study, as it is a review of the RCT method, will operate concurrently with the CRCT.
In accordance with the feasibility study, Health Professionals and Aboriginal Patients are not required to undertake any additional activities, or provide any additional information; rather. Their adherence and response to the CRCT training and surveys, as well as researcher audits of project study records will be used assess feasibility.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot CRCT studies do not have the same objectives as a full CRCT, therefore it is not normal practice to use formal power calculations. To address the objectives of this study we refer to Whitehead et al., (2016), and we have determined that a target of n=20 HPs per cluster will be sufficient to determine methodology required for conducting a full-scale CRCT.

To determine the feasibility, acceptability and practicality of delivering culturally tailored smoking cessation using the KTS workbooks in combination with AR software, we have determined that HPs (Standardised Training and Standardised Training + KTS) should attempt to recruit 12 Aboriginal Patients in total from each hospital.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
23/08/2021
Date of last participant enrolment
Anticipated
31/10/2021
Actual
Date of last data collection
Anticipated
17/12/2021
Actual
Sample size
Target
64
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 19057 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 19058 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 33607 0
5011 - Woodville
Recruitment postcode(s) [2] 33608 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 308271 0
Government body
Name [1] 308271 0
National Health and Medical Research Council
Country [1] 308271 0
Australia
Funding source category [2] 308276 0
University
Name [2] 308276 0
University of South Australia
Country [2] 308276 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
UniSA
101 Currie St,
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 309067 0
None
Name [1] 309067 0
Address [1] 309067 0
Country [1] 309067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308247 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 308247 0
Ethics committee country [1] 308247 0
Australia
Date submitted for ethics approval [1] 308247 0
29/03/2021
Approval date [1] 308247 0
07/06/2021
Ethics approval number [1] 308247 0
#04-21-925

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110062 0
A/Prof Kristin Carson-Chahhoud
Address 110062 0
University of South Australia
Translational Medicine and Technology Group
GPO Box 2471,
Adelaide SA 5001
Country 110062 0
Australia
Phone 110062 0
+61 883020453
Fax 110062 0
Email 110062 0
[email protected]
Contact person for public queries
Name 110063 0
Kristin Carson-Chahhoud
Address 110063 0
University of South Australia
Translational Medicine and Technology Group
GPO Box 2471,
Adelaide SA 5001
Country 110063 0
Australia
Phone 110063 0
+61 883020453
Fax 110063 0
Email 110063 0
[email protected]
Contact person for scientific queries
Name 110064 0
Kristin Carson-Chahhoud
Address 110064 0
University of South Australia
Translational Medicine and Technology Group
GPO Box 2471,
Adelaide SA 5001
Country 110064 0
Australia
Phone 110064 0
+61 883020453
Fax 110064 0
Email 110064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual Participant Data will not be shared due to the governance arrangements agreed with the approved ethics document enabling this research.


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.