Effects of the Shared-decision Making Training Program

NCT06121076 | Completed

• 1 other identifier: SdmEbp2023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Competence

Keywords

shared-decision making; evidence-based practice; midwife

Outcome Measures

Primary Outcomes (5)

• SDM competency from midwives' perspective

  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.

  baseline, week 2, week 4

• SDM competency from observers' perspective

  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.

  baseline, week 2, week 4

• SDM competency from patients' perspective

  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.

  baseline, week 2, week 4

• Decision support skill

  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.

  baseline, week 2, week 4

• Communication skill

  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.

  baseline, week 2, week 4

Secondary Outcomes (2)

• Level of EBP competency

  baseline, week 2, week 4

• Decision conflict

  baseline, week 2, week 4

Study Arms (2)

SDM-EBP training

EXPERIMENTAL

the group received SDM combined with EBP training

Other: SDM-EBP training

control

OTHER

the group received received SDM without EBP training

Other: SDM-EBP training

Interventions

SDM-EBP training OTHER

A 20-hour tailored SDM combined with EBP training program consisting of a seven-hour lecture and a four-hour hands-on practice session.

SDM-EBP training; control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• provide hands-on care to patients for at least three months
• licensed to practice midwifery
• willing to participate in the study.
• 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

You may not qualify if:

• Patients requiring emergency medical attention

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• National Taipei University of Nursing and Health Sciences: collaborator

Study Sites (1)

Obstetric hospital

Ho Chi Minh City, 700000, Vietnam

Location

Study Officials

• Mei-ling Yeh, PhD

  National Taipei University of Nursing and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 7, 2023
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)