TrainingNCT05409313
EBP-SDM Training Program Empowers Nurses' Competency and Performance
A study testing EBP training and SDM training in people with Training and Nurse, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study will be to evaluate the effect on competency and performance of EBP and SDM. 1. To evaluate the effect of the 5As-steps EBP training program on competency in nurses-midwives 2. To evaluate the effect of the SDM training program on performance in in nurses-midwives Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Training, Nurse, Evidence-based Practice
- What is being tested?
- EBP training and SDM training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Mar 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Work more than 3 months
- Registered Nursing in Taiwan
Who cannot join
- Not providing care in clinical.
- On-job and received the school education.
- Received the training program of EBP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Training Empowers Hospital Nurses' Competency and Application of Evidence-based Practice and Shared Decision-making: a Randomized Controlled Trial
The purpose of this study will be to evaluate the effect on competency and performance of EBP and SDM.
- To evaluate the effect of the 5As-steps EBP training program on competency in nurses-midwives
- To evaluate the effect of the SDM training program on performance in in nurses-midwives
Read the detailed description
This is a randomized controlled trial with repeated measures at four time points which are before the start of the intervention (Baseline), classroom teaching (posttest 1), clinical practice (posttest 2), and follow-up (posttest 3). The experimental group will receive the tailored EBP-SDM training program both in classroom and clinical settings.A total of 72 nurses will be recruited from one hospital.
The interventions of this study will integrate classroom activities with practical learning experiences. The investigators previously developed the teaching model of 5As-steps EBP which will be use as framework for the teaching. Teaching activities involve lectures, group and individual consulting, hand-on activities, clinical cases, role play exercises, and debriefing. Previous researchers described the fundamental principles and the 5 steps of EBP and adapted those principles into their 5As-steps EBP model as shown in the following figure. The first step is asking. Nurses-midwives have to establish a well-built clinical question with all the components facilitating performance literature review for relevant database. Step two is acquiring in which nurse-midwives efficiently find the best relevant evidence to answer the question. The third step is appraising meaning that nurse-midwives carefully and systematically examining the trustworthiness of research findings. The fourth step is applying of the appraised evidence to the patients. This step requires integrating the best evidence with clinical expertise and patients' unique values and preference. The final step assessing the outcomes. At this step, nurse-midwives evaluate effectiveness and efficacy of the performance and change in practice. With conscientious application of these 5 steps, each time the cycle completes a turn, patient care and clinical practice is improved.
The Ottawa Decision Support Framework will be use as framework for the teaching. As shown in the following figure, Ottawa Decision Support Framework summarizes three elements in SDM, which are decisional needs, decision outcomes, and decision support . This framework integrates viewpoints from social psychology, economics and social support, and applies to all individuals taking part in decision making including the patients, family members and healthcare providers.
Instruments is listed as following:
(1)Health Sciences-Evidence Based Practice (HS-EBP);(2)9-item Shared Decision-Making Questionnaire (SDM-Q-9 and SDM-Q-Nr);(3)OPTION5;(4)Four Habits Coding Scheme (4HSC);(5)Brief Decision Support Analysis (DSAT-10);(6)Demographic Questionnaire;(7)SURE Test.
- Conditions
- Training, Nurse, Evidence-based Practice
- Being tested
- EBP training, SDM training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBP trainingBehavioural
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.
SDM trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EBP and SDM training group | Experimental | A total of 36 nurses will be received EBP and SDM training program. Receives: Behavioral: EBP training; Behavioral: SDM training |
| SDM training group | Active comparator | A total of 36 nurses will be received SDM training alone. Receives: Behavioral: SDM training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start31 Mar 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-ling Yeh, Professor, Study chair, School of Nursing National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409313
- Sponsor's protocol ID
- CHGH110-IU09
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Training Empowers Hospital Nurses' Competency and Application of Evidence-based Practice and Shared Decision-making: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05409313
- Acronym / sponsor ID
- CHGH110-IU09
- Conditions
- Training, Nurse, Evidence-based Practice
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to evaluate the effect on competency and performance of EBP and SDM.
- To evaluate the effect of the 5As-steps EBP training program on competency in nurses-midwives
- To evaluate the effect of the SDM training program on performance in in nurses-midwives
Detailed description
This is a randomized controlled trial with repeated measures at four time points which are before the start of the intervention (Baseline), classroom teaching (posttest 1), clinical practice (posttest 2), and follow-up (posttest 3). The experimental group will receive the tailored EBP-SDM training program both in classroom and clinical settings.A total of 72 nurses will be recruited from one hospital.
The interventions of this study will integrate classroom activities with practical learning experiences. The investigators previously developed the teaching model of 5As-steps EBP which will be use as framework for the teaching. Teaching activities involve lectures, group and individual consulting, hand-on activities, clinical cases, role play exercises, and debriefing. Previous researchers described the fundamental principles and the 5 steps of EBP and adapted those principles into their 5As-steps EBP model as shown in the following figure. The first step is asking. Nurses-midwives have to establish a well-built clinical question with all the components facilitating performance literature review for relevant database. Step two is acquiring in which nurse-midwives efficiently find the best relevant evidence to answer the question. The third step is appraising meaning that nurse-midwives carefully and systematically examining the trustworthiness of research findings. The fourth step is applying of the appraised evidence to the patients. This step requires integrating the best evidence with clinical expertise and patients' unique values and preference. The final step assessing the outcomes. At this step, nurse-midwives evaluate effectiveness and efficacy of the performance and change in practice. With conscientious application of these 5 steps, each time the cycle completes a turn, patient care and clinical practice is improved.
The Ottawa Decision Support Framework will be use as framework for the teaching. As shown in the following figure, Ottawa Decision Support Framework summarizes three elements in SDM, which are decisional needs, decision outcomes, and decision support . This framework integrates viewpoints from social psychology, economics and social support, and applies to all individuals taking part in decision making including the patients, family members and healthcare providers.
Instruments is listed as following:
(1)Health Sciences-Evidence Based Practice (HS-EBP);(2)9-item Shared Decision-Making Questionnaire (SDM-Q-9 and SDM-Q-Nr);(3)OPTION5;(4)Four Habits Coding Scheme (4HSC);(5)Brief Decision Support Analysis (DSAT-10);(6)Demographic Questionnaire;(7)SURE Test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBP and SDM training group | Experimental | Behavioral: EBP training, Behavioral: SDM trainingA total of 36 nurses will be received EBP and SDM training program. |
| SDM training group | Active comparator | Behavioral: SDM trainingA total of 36 nurses will be received SDM training alone. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Work more than 3 months
- Registered Nursing in Taiwan
Key exclusion criteria (3 listed)
- Not providing care in clinical.
- On-job and received the school education.
- Received the training program of EBP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EBP trainingThe 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. | Behavioural | EBP and SDM training group |
| SDM trainingA 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. | Behavioural | EBP and SDM training group, SDM training group |
Primary outcome
Participant characteristics questionnaire
Time frame: before intervention
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.
Change is assessed of Health Sciences-Evidence Based Practice questionnaire
Time frame: Change from baseline, Week 2, Week 6, and Week 10
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 is assessed of SDM-Q-9 and SDM-Q-Nr questionnaire
Time frame: Change from baseline, Week 2, Week 6, and Week 10
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 is assessed of DSAT-10 questionnaire
Time frame: Change from baseline and Week 10
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 is assessed of OPTION5 questionnaire
Time frame: Change from baseline and Week 10
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 is assessed of Four Habits Coding Scheme questionnaire
Time frame: Change from baseline and Week 10
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 is assessed of SURE test questionnaire
Time frame: Change from baseline and Week 10
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-ling Yeh, Professor study chair
School of Nursing National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBP training and SDM training in people with Training and Nurse, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant characteristics questionnaire (time frame: before intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.