跳至主要内容
临床试验/NCT06121076
NCT06121076已完成不适用

A Cross-cultural Project of the Tailored EBP-SDM Training Program Empowers Nurses and Midwives in Competency and Performance.

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
SDM competency from observers' perspective

研究概览

简要总结

The goal of this intervention study is to test the effectiveness of a training program for hospital-based midwives. The main questions it aims to answer are: •Does SDM combined EBP training improve midwives' SDM and EBP competency? • What are factors related to SDM competency in midwives? Participants will participate in a 20-hour training program, including lectures and hands-on practice sessions. Researchers will compare groups that receive SDM training with or without EBP training to see if there are changes in midwives' SDM and EBP competency.

详细描述

This study aimed to evaluate the effect of SDM training program, with or without EBP, on the level of midwives' SDM and EBP competency. This randomized controlled trial recruited participants from 18 departments of an obstetrics and gynecology hospital in Vietnam. 72 midwives (36 in each group) and 404 patients were required. Eligible midwives were ones who provided the hands-on care of patients for at least three months, were licensed to practice midwifery, and were willing to participate in the study. Each participating midwife conducted three encounters with real patients who were conveniently selected. Patients at least 18 years old, having SURE test scores less than 4, and willing to participate in the study were invited. Patients requiring emergency medical attention were excluded. The intervention group received a tailored training program that combined SDM with EBP, while the control group received SDM training alone. The outcomes related to SDM (measured by SDM-Q-Doc, SDM-Q-9, DSC, OPTION5, DSAT10, and 4HCS) and EBP (measured by HS-EBP) were evaluated at baseline, Week 2, and/or Week 4.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • for midwives:
  • provide hands-on care to patients for at least three months
  • licensed to practice midwifery
  • willing to participate in the study.
  • Inclusion Criteria for patients:
  • having SURE test score less than 4 (SURE was a decisional conflict screening tool. A score less than 4 was a positive result for decisional conflict)
  • willing to participate in the study

排除标准

  • for patients:
  • Patients requiring emergency medical attention

结局指标

主要结局

SDM competency from observers' perspective

时间窗: baseline, week 2, week 4

The SDM competency, from the observers' perspective, is defined as the efforts of healthcare professionals to involve patients in decision-making from blinded observers. It is measured by the Observing Patient Involvement scale (OPTION5). Each item was scored on a 5-point scale from 0 (no effort) to 4 (exemplary effort). A total score ranged from 0\~20, with higher scores and higher levels of the extent to which healthcare providers involved patients in decision-making.

Decision support skill

时间窗: baseline, week 2, week 4

Decision support skill is defined as midwives' competency to support patients during the decision-making process. It is measured from blinded observers using the Decision Support Analysis Tool (DSAT10). DSAT10 has five categories of decision-making status, knowledge of options, values associated with outcomes of options, others' involvement, and next steps plan. Assessing and intervening are differentiated in the scale. Each check item was rated as present (1) or absent (0). Not applicable was used in circumstances when it was not necessary to have met an item. A total score ranged from 0\~10, with higher scores for better SDM skills.

SDM competency from midwives' perspective

时间窗: baseline, week 2, week 4

The SDM competency from a midwife's perspective is defined as the ability perceived by midwives to involve patients in the decision-making process. It is measured using the 9-item Shared Decision-Making Questionnaires for healthcare professionals (SDM-Doc). The questionnaire consists of 9 items, and each item represents a statement that features various aspects of SDM using a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree). A total score ranged from 0\~45; higher scores indicate a higher level of SDM competency.

SDM competency from patients' perspective

时间窗: baseline, week 2, week 4

The SDM competency from a patient's perspective is defined as the patient's perceived extent to which SDM has taken place in the encounter with midwives. It is measured using the 9-item Shared Decision-Making Questionnaires for patients (SDM-Q-9). The questionnaire consists of 9 items, and each item represents a statement that features various aspects of SDM using a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree). A total score ranged from 0\~45; higher scores indicate a higher level of SDM competency.

Communication skill

时间窗: baseline, week 2, week 4

Communication skill is defined as midwives' competency to express verbal and non-verbal behaviors of patient- and relationship-centered communication. It is measured from blinded observers using the Four Habits Coding Scheme. The 4HCS consisted of 23 items with four habits of basic medical interview, including invest in the beginning (6 items), elicit the patient's perspective (3 items), demonstrate empathy (4 items), and invest in the end (10 items). Each item was scored on a 5-point scale from 1 (ineffective) to 5 (highly effective). A total score ranged from 23\~115, with higher scores for more effective patient-centered communication in consultations.

次要结局

  • Level of EBP competency(baseline, week 2, week 4)
  • Decision conflict(baseline, week 2, week 4)

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Quyen Thao Nguyen

lecturer

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

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