Abstract
BackgroundIn the Netherlands, midwives are required to use the ‘V-MIS’ (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking. This counselling protocol is often poorly implemented in midwifery practices. It may also be less suitable for pregnant woman with low socioeconomic status or functional health illiteracy. We created an adapted version of the V-MIS protocol that is intended to facilitate implementation in midwifery practices: PROMISE (PROtocol for growing up smokefree using a Minimal smoking cessation Intervention Strategy in the Early stages of life). For this adapted protocol, midwives use carbon monoxide meters, storyboard leaflets, and specific communication techniques for women with functional health illiteracy. They will receive a face-to-face training in using these materials and communication techniques.MethodsThe effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will then train them, subsequently, at regular intervals (‘steps’). At each step, practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. Among them, we will assess smoking status and health-related outcome before and after pregnancy.DiscussionThe PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.Trial registrationDutch Trial Registry: NTR 6305/NL6158. Registered on 20 December 2016.
Highlights
In the Netherlands, midwives are required to use the ‘V-MIS’ (Minimal Intervention Strategy for Midwives) smoking cessation counselling protocol to help pregnant women quit smoking
Using a stepped-wedge randomised controlled design, we will evaluate the effectiveness of the PROMISE protocol while it is being implemented in 23 midwifery practices and 3 obstetrics hospital departments across three regions in the Netherlands
Over the course of the study period, we will assess the rate at which midwives and Obstetrics and gynaecology doctor (OB-GYN) discuss smoking cessations strategies with their clients
Summary
The effectiveness and implementation of PROMISE will be tested in a stepped-wedge cluster randomised controlled trial. We will randomise clusters of midwifery practices and departments in hospitals. We will train them, subsequently, at regular intervals (‘steps’). Practices that will receive training cross over from the control condition to the experimental condition. We will measure how well the PROMISE protocol has been implemented by assessing the rate of pregnant women that received detailed smoking cessation counselling from their midwives (primary outcome). Our secondary target group is pregnant women with functional health illiteracy and low socioeconomic status. We will assess smoking status and health-related outcome before and after pregnancy
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