Tobacco and Alcohol Research
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N-READY Workstreams

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Workstream 1: Discover

Discover from published work how NRT is best used in pregnancy and, by speaking with pregnant women who smoke and Stop Smoking Practitioners, identify the information women need to address any concerns about NRT and to help them to use this effectively.

We will carry out extensive reviews of existing evidence looking at NRT safety, nicotine exposure from NRT and factors that influence NRT use in pregnancy.

We will then speak with pregnant women who smoke to explore their views and beliefs about stopping smoking in pregnancy, including using NRT. We also want to talk with Stop Smoking Practitioners and to watch their consultations to find out how they support pregnant women and their reasons for deciding whether or not to advise use of NRT.

We will hold an expert focus group to help us decide on the best content, duration and delivery methods for an NRT stop smoking intervention. This will then be reviewed by pregnant women who smoke and Stop Smoking Practitioners to make sure it is acceptable and potentially useful. We will also consult our Patient and Public Involvement (PPI) Advisory Panel. The NRT stop smoking intervention will be designed to complement approaches currently used in NHS behavioural support for pregnant women. 

Methods

  • Systematic reviews
  • Interviews with pregnant women who smoke
  • Focus groups with Stop Smoking Practitioners
  • Video/audio simulated interviews with Stop Smoking Practitioners
  • Expert consensus building exercise
 
Workstream 2: design and Develop

Design and refine a prototype intervention which addresses concerns and encourages pregnant women who smoke to use enough NRT for this to work.

Using the findings from Workstream 1 and behavioural theory, we will design a prototype NRT stop smoking intervention which addresses concerns about NRT and encourages pregnant women who smoke to use enough NRT for this to work, including providing ‘dual’ NRT - a longer acting NRT (e.g. patch) together with a shorter acting one (e.g. inhalator). The intervention will be tested on a small number of women and then optimised.

We will also develop and finalise an adherence outcome measure to be used in Workstream 3 by comparing approaches.

Methods

  • A prototype intervention developed and delivered to sequential cohorts of pregnant women who smoke (n=10) from whom we will seek feedback (up to 40 participants) (telephone, text, email and /or paper questionnaires used to collect data)

 

 
Workstream 3: Test NRT adherence

 

 

Test whether or not pregnant women who receive the NRT stop smoking intervention use more NRT.

We will run a randomised control trial (RCT) to see whether the NRT stop smoking intervention helps to improve adherence, while monitoring the impact on nicotine exposure. A process evaluation will run alongside this, to explore intervention fidelity and to establish how delivery might be facilitated in routine care. We will also monitor costs of the intervention delivery.

Methods

  • RCT enrolling 200 pregnant women who smoke (telephone, text, email and /or paper questionnaires used to collect data)
  • Video/audio recording a random section of initial practitioner-client stop smoking interactions in the intervention group and scored against a fidelity checklist

 

 
Workstream 4: Test stop smoking

Test whether or not the NRT stop smoking intervention, used within routine NHS stop smoking services, causes more pregnant women who smoke to quit than current NHS support.

We will begin by demonstrating important aspects of feasibility for an RCT (e.g. recruitment of sufficient number of trial centres). Following a checkpoint assessment, the full RCT will start and progress until completed - providing a ‘within-trial’ pilot demonstrates that this is capable of being completed (e.g. recruitment is fast enough and primary outcome measurement is sufficiently complete).

The full trial will to test whether the NRT stop smoking intervention helps more pregnant women who smoke to quit than current NHS stop smoking support. The primary outcome will be smoking abstinence for at least 6 months. We will undertake an incremental cost-effectiveness analysis of the intervention over and above usual care. Costs of delivering the intervention and usual care will be based on costs of training, staff, overheads costs, NRT. We will us a ‘fidelity checklist’ to assess the extent to which the intervention is delivered in line with the intervention manual.

Methods

  • A cluster-randomised, stepped-wedge RCT with ‘within trial’ pilot (sample size = 2550 pregnant ‘quitters’) (telephone, text, email and /or paper questionnaires used to collect data)
  • Video/audio recording a random section of initial practitioner-client stop smoking interactions in the intervention group and scored against a fidelity checklist

 

 

 

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Tobacco and Alcohol research

The University of Nottingham

email:Chris Hill