The three arm intervention trial replicates the methodology employed in a study evaluating the effectiveness of progressive fidelity in the acquisition of Intravenous cannulation technical and non-technical skills in medical students [21].
Sample & intervention
In our study, first year Bachelor of Midwifery (BM) and Dual Degree (DD) Bachelor of Nursing and Bachelor of Midwifery students from the University of Queensland (UQ), who have yet to receive theoretical instruction on vaginal examination will be recruited. Following random allocation via a computer generated block randomization schedule, participants will be assigned to one of three intervention arms. The participants will receive identical theoretical instruction in the performance of vaginal examination. All participants will be provided with a list of process goals, including woman centred care behaviours developed from published guidelines and will be briefed on the nature and expectations of the simulation experience by a simulation expert.
Senior Bachelor of Midwifery (BM) and Dual Degree (DD) Bachelor of Nursing and Bachelor of Midwifery students (3rd year or 4th year students respectively) will be recruited to act in the role of the standardized patient. These students will be provided with training and scripts to be followed as standardized patients and will be briefed on the nature and expectations of the experience by the simulation expert. The standard scenario, including all associated history, details and expected responses to questions, will be developed by the group participating as standardized patients, guided by the simulation expert.
To achieve similar statistical significance demonstrated in the Brydges et al. [21] methodology it was determined that;
Intervention arm 1
Intervention Arm 1 (n = 35) will receive low fidelity skills training using a partial task trainer positioned on a standard hospital birth-suite bed. Partial task trainers are designed to replicate a part of a system or process, in this research, Model-Med Charlie Obstetric Trainer® is used (Figure 1).
Intervention arm 2
Intervention Arm 2 (n = 35) will receive medium fidelity skills training using the same partial task trainer as provided in Intervention Arm 1, but with the addition of a ‘Flat Maggie’ positioned on a standard hospital birth-suite bed. ‘Flat Maggie’ will be draped over pillows in a bed to visually simulate a pregnant woman and the partial task trainer will be appropriately positioned in relation to the ‘Flat Maggie’ for the skill to be practiced (Figure 2).
Intervention arm 3
Intervention Arm 3 (n = 35) will receive progressive fidelity skills training through low – partial task trainers, medium – ‘Flat Maggie’ with the partial-task trainer, and then to high fidelity – Standardized patients with the partial-task trainer positioned on a standard hospital birth-suite bed. Standardized patients will be senior midwifery students who act the part of the pregnant woman, using a consistent and standard approach. It is important to note that standardized patients will not be subject to vaginal examination, rather they will act the role of the woman and a partial task trainer will be appropriately positioned for the skill to be performed (Figure 3).
Sample size and statistical power
To ensure that the type I error rate for the entire study is 0.05, the sample size calculations used a type I error rate of 0.025 (Bonferroni’s correction) to account for the two primary outcome measure; GRS and IPPI scores.
GRS
Based on data from Brydges et al. [21], the expected sample standard deviation to be used in the sample size calculation was 3.6. Along with this parameter, a power of 80%, type I error of 0.025, and the assumption that the average GRS scores in the progressive, medium and low fidelity groups will be 11, 10 and 8, 102 participants are required. Inter-rater reliability (intraclass correlation = 0.76) and internal consistency (Cronbach’s alpha = 0.75) of the GRS have been demonstrated in published research studies [22].
IPPI
Based on data from Brydges et al [21], the expected sample standard deviation to be used in the sample size calculation was 18. Along with this parameter, a power of 80%, type I error of 0.025, and the assumption that the average IPPI scores in the progressive, medium and low fidelity groups will be 40, 33 and 25, 105 participants are required. Validation of the IPPI has been demonstrated in previous research studies; a recent study reported inter-rater reliability (intraclass correlation = 0.73), internal consistency (Cronbach’s alpha = 0.65) and discriminant validity (p < 0.001) [22].
WCCS
A conceptual framework has been proposed for woman centred care in which eight key concepts have been identified and defined, drawing on ANMC [18], Brison [19], Leap [4] and Leap [20]. The key concepts are the foundations of woman’s sphere, holism, self-determination, the sharing of power in the relationship, individuality, continuum, informed decision making and the midwife-woman relationship. These concepts are linked to competencies, elements and cues from the National Competency Standards for the Midwife [18] and translation to practice behaviors identified and described. This forms the basis of the tool to assess performance of these behaviours during practice of the clinical technical skill vaginal examination. As no comparable tool exists within the literature, the WCCS will be piloted in this research study.
Therefore, 105 participants are required in total (35 per group) for this study.
Statistical methods
The descriptive characteristics of each of the three groups will be presented; continuous characteristics will first be assessed for distribution using histograms and the Shapiro-Wilk test. If the data is normally distributed, the mean and standard deviation will be presented, and for data that is not normally distributed, the median and interquartile range will be reported. Numbers and percentages will be used for categorical data. Comparison of the primary outcome measure amongst the three groups will be undertaken using either analysis of variance (ANOVA) or Kruskal-Wallis testing, dependent on the distribution of the outcome. If a statistically significant difference is found (at the 0.025 level), appropriate post-hoc testing will be conducted to determine which groups are different.
Data collection
Participants’ performance of the skills will be video recorded and downloaded on to a computer and stored on a secure server. Videos will only be viewed by AW and two clinical Midwife Research Assistants external to the research team. Their scores for the three instruments will be entered directly into a database set up using Remark®.
The Global Rating Scale (GRS) [16] will be used to evaluate technical skills acquisition, the Integrated Procedural Performance Instrument (IPPI) [17] will be used to evaluate skills integration, and the Woman Centred Care Scale (WCCS) will be piloted. Inter-rater reliability and intra-rater reliability testing will be integrated into the design of this research.
Following completion of the activity and debriefing, all participants will evaluate the simulation experience using a University of Queensland procedural skills workshop evaluation.
Analysis of data will be guided by the specific instruments used. Qualitative data that emerges from debriefing or evaluation of the simulation experience will be thematically analyzed.
Study setting/location
The study will be conducted at the Mater Education Practice Improvement Centre (MEPIC), Raymond Terrace, South Brisbane, Queensland, Australia.
Study population
First year Bachelor of Midwifery (BM) and Dual Degree (DD) Bachelor of Nursing and Bachelor of Midwifery students from the University of Queensland (UQ), who have yet to receive theoretical instruction on vaginal examination will be recruited. Students will be provided with full details of the study and receive a participant information letter. Recruitment of participants will be undertaken by a University of Queensland (UQ) staff member who is not involved in the Bachelor of Midwifery or Dual Degree programs and is not a member of the investigation team. The students who agree to be involved in the study will undertake the planned simulation instruction and will be randomly assigned to one of the three intervention arms.
Senior Bachelor of Midwifery (BM) and Dual Degree (DD) Bachelor of Nursing and Bachelor of Midwifery students (3rd year or 4th year students respectively) will be recruited to act in the role of the standardized patient. They will be provided with full details of the study and receive a participant information letter. Recruitment will be undertaken by a University of Queensland (UQ) staff member who is not involved in the Bachelor of Midwifery or Dual Degree programs and is not a member of the investigation team. Those students who agree to be involved in the study will be given training to undertake the role of the standardized patient in the planned intervention by a simulation expert, and will receive a certificate of acknowledgement.
Participant inclusion criteria
In order to be included in the intervention component of the study participants will be volunteer first year Bachelor of Midwifery or Dual Degree students who have yet to receive instruction in performing vaginal examination. Participants will likely be between the ages of 17 - 60 years and either female or male.
In order to be included in the standardized patient group participants will be volunteer senior midwifery students in either the Bachelor of Midwifery or Dual degree (in 3rd or 4th year respectively); these students will receive both instruction in, and experiences of, performing vaginal examination and recognizing woman centred care behaviors.
Participant exclusion criteria
Students who are not enrolled in a midwifery program will be excluded from participating. Participation in this simulation project is voluntary, and participants will be free to withdraw at any time without consequence.
Safety considerations
The research design will minimize the risks of harm or discomfort to participants and ensure the selection, recruitment, exclusion and inclusion of participants is fair and will not overburden any group of students or staff. Participant information sheets will clearly outline the aim, benefits and involvement in the study, including adding value to future curriculum development processes at the University of Queensland. The research design will carefully address the issue of consent. Participants will be given sufficient information about the research in order for them to give informed consent and all participants are to be advised that they are free at any time to withdraw consent to further involvement in the research without consequence.
There is the unlikely potential for first year student participants to experience stress / distress / discomfort similar to that experienced in real life clinical practice. Third and fourth year student participants may also have the unlikely potential to experience stress / distress / discomfort similar to that experienced by individuals engaging in role play/simulation. No invasive procedures will be performed on human volunteers, using simulation models / manikins in these circumstances. Participants will all be midwifery students who are expected to engage in clinical practice experience in real life settings as part of their preparation for professional life on graduation.
Debriefing will be built into the simulation experience and will be conducted by a simulation expert to minimize the risk of distress. The simulation scenarios will also be observed by room monitors whom will be experienced clinicians able to intervene if any undue participant stress / distress or discomfort is identified. All participants will have information given to them that states if they experienced psychological stress / distress or discomfort, they may talk privately with any member of the research team to gain assistance, or access existing support services from either Mater Health Services or the University of Queensland freely and without prejudice.
Ethical considerations
This research has secured ethical clearance from the Human Research and Ethics Committees of the University of Queensland (Protocol Ref No 2012000889) and the Mater Health Services, Brisbane (Protocol Ref No 2012-53).