CompetenceSdmEbpNCT06121076
Effects of the Shared-decision Making Training Program
A study testing SDM-EBP training in people with Competence, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Competence
- What is being tested?
- SDM-EBP training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2021to 1 Jun 2023
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Patients requiring emergency medical attention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-cultural Project of the Tailored EBP-SDM Training Program Empowers Nurses and Midwives in Competency and Performance.
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.
Read the detailed description
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.
- Conditions
- Competence
- Being tested
- SDM-EBP training
- Keywords
- shared-decision making, evidence-based practice, midwife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDM-EBP trainingOther
A 20-hour tailored SDM combined with EBP training program consisting of a seven-hour lecture and a four-hour hands-on practice session.
| Study group | Role | What they receive |
|---|---|---|
| SDM-EBP training | Experimental | the group received SDM combined with EBP training Receives: Other: SDM-EBP training |
| control | Other | the group received received SDM without EBP training Receives: Other: SDM-EBP training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, week 2, week 4
Secondary outcomes (2)
Level of EBP competency
The EBP competency is defined as attitude, knowledge, and skill that is perceived by midwives toward evidence-based practice. It is assessed using the Health Sciences-Evidence Based Practice questionnaire (HS-EBP). The 60-item HS-EBP includes five domains of 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). Each item was rated on a 10-point Likert scale (ranging from 1 to 10), with higher scores indicating a greater degree of agreement.
Measured: baseline, week 2, week 4
Decision conflict
Decision conflict is defined as the degree of conflict experienced by patients when making treatment-related decisions. It is measured by the Decision Conflict scale (DCS). DCS had 16 items and is covered by five subscales, including informed (3 items), values clarity (3 items), social support (3 items), uncertainty (3 items), and effective decision (4 items). Each item was scored on a 5-point Likert scale from 0 (strongly agree) to 4 (strongly disagree). In each subscale, the scores of the items were summed up, divided by the number of items, and multiplied by 25, with a possible score ranging from 0 (no decision conflict) to 100 (extremely high decision conflict). A score below 25 indicated the implementation of the decision, and scores exceeding 37.5 signify decision delay or feeling unsure about implementing their decisions.
Measured: baseline, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CompetenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Principal investigator, Quyen Thao Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Mei-ling Yeh, PhD, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121076
- Sponsor's protocol ID
- SdmEbp2023
- Acronym
- SdmEbp
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-cultural Project of the Tailored EBP-SDM Training Program Empowers Nurses and Midwives in Competency and Performance.
- ClinicalTrials.gov ID
- NCT06121076
- Acronym / sponsor ID
- SdmEbp / SdmEbp2023
- Conditions
- Competence
- Keywords
- shared-decision making, evidence-based practice, midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 7 Nov 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDM-EBP training | Experimental | Other: SDM-EBP trainingthe group received SDM combined with EBP training |
| control | Other | Other: SDM-EBP trainingthe group received received SDM without EBP training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients requiring emergency medical attention
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 |
|---|---|---|
| SDM-EBP trainingA 20-hour tailored SDM combined with EBP training program consisting of a seven-hour lecture and a four-hour hands-on practice session. | Other | SDM-EBP training, control |
Primary outcome
SDM competency from midwives' perspective
Time frame: 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 observers' perspective
Time frame: 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.
SDM competency from patients' perspective
Time frame: 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.
Decision support skill
Time frame: 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.
Communication skill
Time frame: 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.
2 secondary outcomes
Level of EBP competency
Time frame: baseline, week 2, week 4
Decision conflict
Time frame: baseline, week 2, week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- 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, PhD study director
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 SDM-EBP training in people with Competence, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 7 Nov 2023. 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 Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SDM competency from midwives' perspective (time frame: baseline, week 2, week 4). The study lists 5 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 7 Nov 2023.