NCT05409313

Brief Summary

The purpose of this study will be to evaluate the effect on competency and performance of EBP and SDM.

  1. 1.To evaluate the effect of the 5As-steps EBP training program on competency in nurses-midwives
  2. 2.To evaluate the effect of the SDM training program on performance in in nurses-midwives

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

3 years

First QC Date

February 20, 2022

Last Update Submit

June 5, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • Participant characteristics questionnaire

    The structured questionnaire designed by researcher. Participants' characteristics included age, sex, educational level, working unit, nursing clinical ladder, and nursing specialties. Participants' self-rated EBP-related abilities included English capability, previous evidence-based nursing learning, experiences, and practice.

    before intervention

  • Change is assessed of Health Sciences-Evidence Based Practice questionnaire

    The outcome of EBP competency and application was measured by the Health Sciences-Evidence Based Practice (HS-EBP) questionnaire, which aimed to assess EBP knowledge, attitudes, behavior, skills, as well as barriers and facilitators of EBP (Fernández-Domínguez et al., 2017). The HS-EBP contained 60 items that divided into five domains: beliefs-attitudes (12 items), results from scientific research (14 items), development of professional practice (10 items), assessment of results (12 items), and barriers-facilitators (12 items). A 10-point Likert scale from 1 to 10 was used for each item for measuring the degree of agreement with respect to EBP competency. A higher HS-EBP score indicated the greater the degree of agreement.

    Change from baseline, Week 2, Week 6, and Week 10

  • Change is assessed of SDM-Q-9 and SDM-Q-Nr questionnaire

    The SDM-Q-9 and SDM-Q-Nr were developed for using in adult clinical setting, it has been adapted to address the SDM between healthcare providers and the patient in separate studies resulting in consistent testing (Scholl et al., 2012). Both SDM-Q-9 and SDM-Q-Nr contain nine items with responses on a 6-point Likert scale ranging between "completely disagree" and "completely agree". A total raw score between 0 and 45 was calculated by summing the scores of all items. The total raw score was transformed by the (Raw Score\*20)/9 formula to create a sum score ranged between 0 and 100. This process assumes that the extent of SDM is additive, therefore, a higher score represents higher perceived SDM.

    Change from baseline, Week 2, Week 6, and Week 10

  • Change is assessed of DSAT-10 questionnaire

    The DSAT-10 was used to evaluate the quality of decision support provided by health professionals to patients facing tough health decisions (Stacey et al., 2008). Each item as present "1" or absent "0" within the encounter. This 10-item scale had adequate inter-rater reliability (kappa = 0.55) and agreement for encounters involving trained nurses (kappa = 0.62) (Stacey et al., 2008).

    Change from baseline and Week 10

  • Change is assessed of OPTION5 questionnaire

    OPTION5 is a brief, theoretically grounded observer measure of SDM based on the talk model (Elwyn et al., 2005). The five items of OPTION5 replicated the response format, assessment, and scoring methods of OPTION12. The scale was designed to measure the magnitude of skill. The scale scoring guidance as, the behavior was not observed "0", a minimal attempt was made to exhibit the behavior "1", asked about patient's preference "2", the behavior was exhibited to a good standard "3", and the behavior was observed and executed to a high standard "4". A total score ranged between 0 and 20, and rescaled between 0 and 100. The adequate inter-rater reliability of OPTION5 was presented by the intra-class correlation (ICC = 0.67).

    Change from baseline and Week 10

  • Change is assessed of Four Habits Coding Scheme questionnaire

    The Four Habits Coding Scheme (4HCS) used to assess and quantify clinicians' communication behaviors from an external rater's perspective (Krupat et al., 2006). The 23-item 4HCS derived from the core skills in communication. Each item was rated on a 5-point scale which the midpoint and the two endpoints in specific behavioral terms indicated that the clinician used little or no jargon "1", some jargon "3", and highly technical "5". Rather than focusing on frequency counts of behavior, each item of the 4HCS was rated on five levels of performance on a 5-point Likert scale, ranging from 1 (not very effective) to 5 (high effective). A total score for each dimension can be calculated by summing the scores of all items of that dimension. Higher scores indicated better performance. The reliability of the 4HCS, the inter-rater coefficients ranged between .69 and .80 (Krupat et al., 2006).

    Change from baseline and Week 10

  • Change is assessed of SURE test questionnaire

    The SURE test was based on the Ottawa Decision Support framework to screen for decisional conflict in patients facing clinical decisions in primary care (Légaré et al., 2010). Each item had a response of yes scoring "1" and a response of no scoring "0", with combined total scores from 4 items less than 4 indicating the patient experiencing decisional conflict. The SURE test showed adequate internal consistency of Kuder-Richardson 20 coefficient of 0.7 (Ferron Parayre et al., 2014).

    Change from baseline and Week 10

Study Arms (2)

EBP and SDM training group

EXPERIMENTAL

A total of 36 nurses will be received EBP and SDM training program.

Behavioral: EBP trainingBehavioral: SDM training

SDM training group

ACTIVE COMPARATOR

A total of 36 nurses will be received SDM training alone.

Behavioral: SDM training

Interventions

EBP trainingBEHAVIORAL

The EBP training program was modified by the 5A-steps EBP teaching model that which aimed to enhance nurses' EBP competencies and application. A 12-hours EBP training consisted of lectures, hand-on practice, group and individual consulting, group presentations and reflections, and disseminating findings to publish.

EBP and SDM training group
SDM trainingBEHAVIORAL

A 10-hour SDM training program included lecture 4 hours and workshops 6 hours, with focused on 3-talk model for SDM skills, 4-habit model for communication skill, and how to use Ottawa personal decision guide. Teaching strategies included lectures, clinical scenarios role play, and post-scenario debriefing. The major contents were SDM concepts and essential steps, SDM tools, strategies for the clinical implementation, the concept and purpose of choosing wisely campaign, and patient-centered communication skills.

EBP and SDM training groupSDM training group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Work more than 3 months
  • Registered Nursing in Taiwan

You may not qualify if:

  • Not providing care in clinical.
  • On-job and received the school education.
  • Received the training program of EBP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cheng Hsin General Hospital

Taipei, 112, Taiwan

Location

Study Officials

  • Mei-ling Yeh, Professor

    School of Nursing National Taipei University of Nursing and Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

June 8, 2022

Study Start

March 31, 2021

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations