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Trial registered on ANZCTR


Registration number
ACTRN12618000576224
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
16/04/2018
Date last updated
11/07/2022
Date data sharing statement initially provided
21/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Incentives to Quit tobacco in Pregnancy
Scientific title
Targeted antenatal smoking cessation intervention in high-risk substance dependent pregnancy: a feasibility study
Secondary ID [1] 293646 0
None
Universal Trial Number (UTN)
Trial acronym
iQuiP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine dependence 305932 0
Condition category
Condition code
Mental Health 305128 305128 0 0
Addiction
Reproductive Health and Childbirth 305217 305217 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the impact of the addition of a smoking treatment to the routine antenatal care offered to pregnant women who smoke tobacco and attend high risk antenatal clinics targeting substance use in pregnancy, at two NSW principle referral hospitals.
The treatment will offer a combination of evidence-based methods to cease smoking during pregnancy, consisting of:
1. Financial incentives (in the form of retail e-vouchers) to be earnt for every instance of biochemically verified abstinence. The first negative sample will earn $3:00 and increase by $0.10 for each negative sample thereafter. Participants will be required to self-monitor breath carbon monoxide (CO) levels according to a set monitoring schedule, starting at twice per day and gradually reducing to every other day. Video evidence of the test and result will be required for verification purposes.
2. Tobacco-related psychosocial counselling delivered by qualified drug and alcohol counsellors. Four x 30 minute antenatal sessions and two postpartum sessions will be offered. Timing of sessions is flexible and will depend on length of time on study, Additional sessions will be available if required.
3. Nicotine replacement therapy, both short- and long-acting, delivered as required as per RACGP guidelines for pregnant women
All three components of the intervention will be available for consenting women aged 16 years and over from study enrolment (any time prior to 33 weeks gestation) until birth. Following delivery, women will be offered counselling and nicotine replacement therapy until 12-weeks postpartum.
The intervention will be offered to all clients and delivered by staff of a NSW health-based drug and alcohol clinical research team. Participation in weekly research data collection interviews is required. With the exception of referral and recruitment, all aspects of the intervention will be delivered to individuals using internet based teleconference facilities (telehealth), telephone and postage services as required.
The feasibility and acceptability of the intervention in this client population will be assessed, along with its cost-effectiveness. Changes in smoking behaviours, pregnancy and birth outcomes of study participants, as well as neonatal outcomes of their infants will be compared to those of a historical control group.
Intervention code [1] 299908 0
Lifestyle
Intervention code [2] 300076 0
Behaviour
Intervention code [3] 300077 0
Treatment: Drugs
Comparator / control treatment
A retrospective chart review of substance use in pregnancy antenatal clinic attendees in the 12-months prior to recruitment (June 2017 to May 2018) will provide comparison data.
Control group
Historical

Outcomes
Primary outcome [1] 304381 0
Intervention feasibility as assessed by:
• Recruitment rate (no. of women recruited divided by no. of women screened)
• Retention rates to birth
• Completion rates at 12-weeks postpartum
• No. of counselling sessions completed
• No. of women taking nicotine replacement therapy (NRT)
• Adherence to NRT (proportion of dispensed NRT that is consumed)
• Partners/household members receiving NRT
Timepoint [1] 304381 0
At study completion
Primary outcome [2] 304382 0
Acceptability of the intervention will be assessed using qualitative and quantitative measures.
• In-depth interviews with participants and SUPPS clinic staff will address (a) perceived effectiveness of each component (b) attitudes towards addressing tobacco smoking and (c) barriers and facilitators to implementation of the intervention as routine antenatal care
• Treatment Acceptability Questionnaire
Timepoint [2] 304382 0
At study completion
Secondary outcome [1] 341778 0
Economic evaluation - a cost-consequence analysis (CCA) will be used to provide an evaluation of the intervention, incorporating all costs incurred with the implementation and delivery of the intervention, incorporating all costs incurred with the implementation and delivery of the intervention and evaluating them against reductions in the health costs of smoking. Outcomes will be: abstinence at delivery and reductions in CO at delivery
Timepoint [1] 341778 0
At study completion
Secondary outcome [2] 341780 0
Change in tobacco smoking outcomes measured by self-reported 7-day point prevalence verified by CO
Timepoint [2] 341780 0
At birth or 38 ± 2 weeks gestational age
Secondary outcome [3] 341782 0
Change in tobacco smoking outcomes measured by self-reported reduction in number of cigarettes smoked/day in past 7-days
Timepoint [3] 341782 0
At birth or 38 ± 2 weeks gestational age
Secondary outcome [4] 342154 0
Rates of miscarriage as assessed by medical chart review
Timepoint [4] 342154 0
At delivery
Secondary outcome [5] 345275 0
Rates of preterm birth as assessed by medical chart review
Timepoint [5] 345275 0
At delivery
Secondary outcome [6] 345478 0
Rates of Stillbirth as assessed by medical chart review
Timepoint [6] 345478 0
At delivery
Secondary outcome [7] 345479 0
Rates of intra-uterine growth restriction as assessed by medical chart review
Timepoint [7] 345479 0
At delivery
Secondary outcome [8] 345480 0
Rates of placental abruption as assessed by medical chart review
Timepoint [8] 345480 0
At delivery
Secondary outcome [9] 345481 0
Rates of placenta praevia as assessed by medical chart review
Timepoint [9] 345481 0
At delivery
Secondary outcome [10] 345482 0
Rates of premature rupture of the membranes as assessed by medical chart review
Timepoint [10] 345482 0
At delivery
Secondary outcome [11] 345484 0
Rates of breastfeeding as assessed by medical chart review
Timepoint [11] 345484 0
At 12-weeks postpartum
Secondary outcome [12] 345485 0
Neonatal birth weight as assessed by medical chart review
Timepoint [12] 345485 0
At delivery
Secondary outcome [13] 345487 0
Neonatal head circumference as assessed by medical chart review
Timepoint [13] 345487 0
At delivery
Secondary outcome [14] 345488 0
Neonatal gestational age as assessed by medical chart review
Timepoint [14] 345488 0
At delivery
Secondary outcome [15] 345489 0
Neonatal malformations as assessed by medical chart review
Timepoint [15] 345489 0
At delivery
Secondary outcome [16] 345493 0
Rates of sudden infant death syndrome as assessed by medical chart review
Timepoint [16] 345493 0
At 12-weeks postpartum

Eligibility
Key inclusion criteria
Participants will be:
1) Pregnant women attending substance use in pregnancy services up to and including 32 weeks gestation
2) Aged >=16 years of age and willing and able to provide written informed consent
3) Current verified daily tobacco smokers interested in reducing smoking during pregnancy with a positive breath carbon monoxide (CO) level greater than 3 p.p.m.
4) Willing and able to comply with requirements of the study
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients will be unable to participate if they will not be available for follow-up

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Economic Evaluation
A cost-consequence analysis (CCA) will be used to provide an evaluation of the intervention. CCA is a descriptive approach to economic analysis that presents intervention costs and outcomes in a readily-understandable, dis-aggregated form. The following costs and offsets will be evaluated.
Costs incurred:
- Financial incentives
- NRT and delivery
- CO monitoring equipment
- Counselling wages and other associated costs
- Administration wages and other associated costs
- Patient costs (out-of-pocket expenses)
- Overheads
Offsets:
- Reductions in costs of smoking
Outcomes:
- Abstinence at delivery
- Reductions in CO at delivery

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2018
Actual
8/08/2018
Date of last participant enrolment
Anticipated
31/07/2019
Actual
17/06/2020
Date of last data collection
Anticipated
31/01/2020
Actual
12/03/2021
Sample size
Target
100
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9701 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 9702 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 14055 0
Canterbury Hospital - Campsie
Recruitment hospital [4] 22783 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 18472 0
2305 - New Lambton
Recruitment postcode(s) [2] 18487 0
2050 - Camperdown
Recruitment postcode(s) [3] 26845 0
2194 - Campsie
Recruitment postcode(s) [4] 38065 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 298263 0
Government body
Name [1] 298263 0
NSW Health Translational Research Grant Scheme
Country [1] 298263 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health Drug and Alcohol Clinical Services
Address
Newcastle Community Health Centre
Level 3, 670 Hunter Street
Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 298370 0
None
Name [1] 298370 0
Address [1] 298370 0
Country [1] 298370 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299266 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299266 0
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 299266 0
Australia
Date submitted for ethics approval [1] 299266 0
27/01/2017
Approval date [1] 299266 0
29/08/2017
Ethics approval number [1] 299266 0
17/04/12/4.05

Summary
Brief summary
Pregnant tobacco smokers with substance use problems are a highly vulnerable and priority population with an over-representation of Aboriginal women. To date, smoking cessation rates are negligible in this target group with few existing effective interventions to support them to quit smoking.

This study aims to assess the feasibility and acceptability of the addition of current evidence-based smoking cessation care to routine prenatal care of women attending a substance use in pregnancy clinic.

The package of care consists of financial incentives contingent on validated smoking reduction and abstinence; counselling for tobacco use in pregnancy and nicotine replacement therapy (short and long acting), tailored to individual needs.

The intervention is single armed, using pre-post comparisons. A group of 100 women recruited from two NSW Health Substance Use in Pregnancy and Parenting Service (SUPPS) antenatal clinics will be provided the intervention. Comparison data will come from the electronic medical records of a historical control group comprising of women attending SUPPS antenatal services for one year prior to the commencement of the study.

The study’s primary objectives are to:
I. Assess the feasibility of addressing tobacco smoking amongst this population
II. Evaluate the acceptability of addressing tobacco smoking and the intervention components among participants and staff of a substance use in pregnancy service.

Its secondary objectives are to:
I. Calculate the cost effectiveness of implementing the intervention into antenatal healthcare of women attending a substance use in pregnancy service
II. Measure changes in tobacco smoking behaviours of study participants
III. Examine the pregnancy and postpartum outcomes of study participants in comparison to those of a historical control group
IV. Examine neonatal outcomes of infants born to study participants in comparison to those of a historical control group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79842 0
Prof Adrian Dunlop
Address 79842 0
Drug and Alcohol Clinical Services
Newcastle Community Health Centre
Level 3, 670 Hunter Street
Newcastle NSW 2290
Country 79842 0
Australia
Phone 79842 0
+61 2 4016 4664
Fax 79842 0
+61 2 4016 4661
Email 79842 0
[email protected]
Contact person for public queries
Name 79843 0
Adrian Dunlop
Address 79843 0
Drug and Alcohol Clinical Services
Newcastle Community Health Centre
Level 3, 670 Hunter Street
Newcastle NSW 2290
Country 79843 0
Australia
Phone 79843 0
+61 2 4016 4664
Fax 79843 0
+61 2 4016 4661
Email 79843 0
[email protected]
Contact person for scientific queries
Name 79844 0
Adrian Dunlop
Address 79844 0
Drug and Alcohol Clinical Services Research
Newcastle Community Health Centre
Level 3, 670 Hunter Street
Newcastle NSW 2290
Country 79844 0
Australia
Phone 79844 0
+61 2 4016 4664
Fax 79844 0
+61 2 4016 4661
Email 79844 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


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
SourceTitleYear of PublicationDOI
EmbaseThe Incentives to Quit tobacco in Pregnancy (IQuiP) protocol: Piloting a financial incentive-based smoking treatment for women attending substance use in pregnancy antenatal services.2019https://dx.doi.org/10.1136/bmjopen-2019-032330
N.B. These documents automatically identified may not have been verified by the study sponsor.