一项针对具有功能性健康素养低下和低社会经济地位的女性进行戒烟咨询培训计划的 stepped-wedge 集群随机对照试验（PROMISE）：研究方案。

Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol.

机构信息

Trimbos Institute, The Netherlands Expertise Centre for Tobacco Control, Utrecht, the Netherlands.

Pharos, Utrecht, the Netherlands.

出版信息

Trials. 2020 Jul 7;21(1):619. doi: 10.1186/s13063-020-04555-0.

DOI:10.1186/s13063-020-04555-0

PMID:32635933

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7341571/

Abstract

BACKGROUND

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. 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.

METHODS

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 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.

DISCUSSION

The PROMISE smoking cessation counselling protocol is intended to help midwives, OB-GYNs, and other obstetrics professionals to support pregnant women with smoking cessation.

TRIAL REGISTRATION

Dutch Trial Registry: NTR 6305/NL6158 . Registered on 20 December 2016.

摘要

背景

在荷兰，助产士需要使用“V-MIS”（助产士最小干预策略）戒烟咨询方案来帮助孕妇戒烟。该咨询方案在助产实践中实施情况往往不佳。它可能也不太适合社会经济地位较低或功能性健康文盲的孕妇。我们创建了 V-MIS 协议的改编版本，旨在促进在助产实践中的实施：PROMISE（使用最小戒烟干预策略在生命早期促进不吸烟的协议）。对于这个改编的协议，助产士使用一氧化碳计、故事板传单和针对功能性健康文盲的女性的特定沟通技巧。他们将接受有关使用这些材料和沟通技巧的面对面培训。

方法

PROMISE 的有效性和实施将在一项逐步楔形集群随机对照试验中进行测试。我们将随机化助产实践和医院部门的集群。然后，我们将定期（“步骤”）对他们进行培训。在每个步骤中，将接受培训的实践从对照条件交叉到实验条件。我们将通过评估从助产士那里接受详细戒烟咨询的孕妇比例（主要结果）来衡量 PROMISE 协议的实施情况。我们的次要目标人群是功能性健康文盲和社会经济地位较低的孕妇。在这些人中，我们将在怀孕前后评估吸烟状况和与健康相关的结果。