Introduction

There are numerous types of services that can be provided by a simulation center; however, the use of standardized patients (SP) is one of the most unique. It is this service that must be executed, controlled, and maintained by the director of the standardized patient program to replicate or evoke the substantial aspects of a clinical encounter in a fully interactive fashion. Additionally, the roles and responsibilities of the standardized patient program director include ensuring the administration of these services, bridging the gap between facility and facilitator, and developing a ready workforce of individuals who are capable of engaging with and assessing learners in a realistic and reproducible manner.[1] 

There are organizations such as the Association of Standardized Patient Educators (ASPE), the Society of Simulation in Healthcare (SSH) and the International Nursing Association of Clinical Simulation Learning (INACSL) that help to set Standards of Best Practice (SOBP) and provide education to those working in this field.

Function

Medicine is an art as well as a science that requires repeated exposure to reach competence.  Enhanced simulation experiences such as training with standardized patients will help to improve confidence and skills among learners. To replicate the real-world experience, the learner must become immersed in the activity. Different types of learners ranging from physicians, advanced practice nurses, physician assistants, registered nurses, residents, medical students, pre-hospital workers, and other interested health care practitioners utilize and benefit from health care simulation experiences. The use of standardized patients is a valuable methodology that can be applied and used for many different types of learners to improve patient care through skill-building and increasing medical knowledge.[1]

The use of standardized patients is recognized as a simulation specialty requiring dedicated personnel, including a standardized patient program director, to support the recruitment, training, and development of individuals and the associated scenarios in which they participate. Multiple groups within simulation have worked to define standards for the function of SP programs, including certification and accreditation, as well as the roles and responsibilities of those working in this area.[2] This manuscript is to help define and explore the roles and responsibilities of simulation personnel directing a standardized patient program.

Issues of Concern

Safety

The standardized patient program director has two primary roles and responsibilities, including ensuring the safety of the SPs as well as providing human resource oversight.  The standardized patient program director must ensure that the SP Standards of Best Practice (SOBP) are followed to ensure the integrity, growth, and safe employment of these individuals when they interact with learners. The Association of Standardized Patient Educators (ASPE) is a global organization that works to set the SP Standards of Best Practice (SOBP).[3] Additional organizations such as the Society of Simulation in Healthcare (SSH) and the International Nursing Association of Clinical Simulation Learning (INACSL) provide information on working with SPs in simulation environments.[4][5] Not following such practices can jeopardize the safety of the SPs, faculty, and learners and hinder the effectiveness of the simulation sessions. Adherence to simulation standards supports consistent delivery of education and overall programmatic function.

As mentioned above, a primary responsibility of the standardized patient director is to ensure safety among SPs, including providing a safe physical and psychological environment; this can be accomplished by following ASPE’s SOBP first domain, a safe work environment. Creating a safe work environment involves three distinct principles: confidentiality, safe work practice, and respect.[3] Confidentiality must be understood, maintained, and applied by SPs as it relates to each specific simulation session. The standardized patient program director must ensure that personal information obtained from each standardized patient encounter is kept private and maintained as per regulatory requirements for the type of institution and services provided. These regulatory requirements may include national regulations such as the Family Educational Rights and Privacy Act (FERPA) in the United States, or even regional, state, or institution level requirements regarding grades and performance data. A standardized patient program director should have an active role in the development and enforcement of policies and procedures related to the assessment and evaluation of learners by standardized patients.

A safe work environment is only achievable if the activity is designed correctly (e.g., number of breaks, rotations, cognitive, physical, and psychological challenges in portraying the patient role). Recognizing and anticipating any potential occupational hazards such as live defibrillators, sharps containers, and allergenic substances are critical to maintaining a safe environment for those participating in simulation activities.[3]

The screening of an SP during the hiring process and specific role assignment can help eliminate some of these risks. Some considerations while hiring standardized patients include but are not limited to identifying if the individual can adapt to change based on feedback and coaching, can sustain the portrayal of the case effectively, have great listening skills and, have the ability to deliver the scenario based on their training accurately.

Some characteristics for role assignments are based on age, gender, language, physical build, race/ethnicity, level of literacy and education, experience with presenting illness, availability to train and partake in the event, and ensuring the SP is dependable.[6] Additionally, to ensure fair grading and evaluation practices, the standardized patient program director should establish practices to ensure there is no conflict of interest or personal relationships between those working as standardized patients and the learners with whom they will be working. 

SP training and development is essential to ensuring the maintenance of SP physical and psychological safety. Each SP should have the option to withdraw from the activity and practice how to terminate an activity if they feel uncomfortable or deem it harmful. There should also be a method for an SP or learner to report an adverse event that they may have experienced during an encounter. The SP program director should also work with the educator(s) for each activity to define what is expected from the SP. The program director must then communicate these expectations and ensure each SP can perform all portions of the role. An SP must understand role boundaries and have the ability to make informed decisions on whether or not to agree to perform each role assignment.[3][7]

Human Resources

While not directly related to simulation-based education, leadership, and human resource experience are vital to the roles and responsibilities of a program director.  Specifically, program directors must have the ability to appropriately hire, train, and review the performance of the SP staff.  While educators focus on the specific education to be provided, and healthcare simulation technology specialists focus on the technical tools and their implementation into simulation activities, those in the SP program director role have the responsibility to manage and support the human resources and staffing to maintain programmatic operations.[8]

Although age, gender, and underlying medical conditions may be part of the interview process and case selection, sexual orientation cannot be asked during the hiring process. This aspect is probably the most demanding and critical part of the role of a standardized patient program director. 

Daily human resource functions within the role of the standardized patient program director include decisions about hiring practices, support and/or enforcement of professional development activities and training, and determination of the number of hours and amount of work available as well as the qualifications of those who will be offered each role.

ASPE’s SOBP describes that it may be appropriate for standardized patients to be independent contractors, employees, or volunteers.[3] The classification should be based on consideration of the role within the institution and the degree of control the program has over how each SP is allowed to approach the preparation and performance of their role. The exact distinction has specific tax and human resource implications and must be considered carefully to ensure that the program complies with applicable laws and regulations before making this determination.[9]

Curriculum Development

The use of standardized patients for teaching and evaluation of clinical skills and use of the Objective Structured Clinical Examination (OSCE), while challenging, is achievable and has been shown to enhance the assessment of learners and support their training outcomes.[10][11]

There are evolving practical and conceptual considerations for the use of standardized patients in high-stakes OSCE assessments for certification and licensure in medical education. For this reason, it is the role and responsibility of the standardized patient program director to enforce the standards of best practice to ensure consistency, provide a safe work environment, partake in case development, deliver SP training, and oversee program management [3]. The function of the SP director is to support the development and delivery of a curriculum that has purposeful assessment components as well as support program improvement and evaluation to enhance learning.

The use of OSCE’s can assist in evaluating clinical skills in a variety of brief task-based stations. Applying an OSCE allows teaching and assessing learners to accomplish course or instructional objectives. The utilization of standardized patients using case material in a simulated safe environment can help a student practice taking a focused history and demonstrating a physical examination, interpreting radiographs or lab results, counseling and/or educating patients, and discussing their findings.

After an SP encounter, learners can document their findings similar to a medical record note they would compose after seeing a patient in an office, clinic, or emergency department. This opportunity of summative and formative teaching can be measured, observed, and analyzed. Feedback to the student can include self-assessment checklists, score reports, global ratings, and written or verbal comments. Direct observation of such encounters can provide invaluable feedback on student performance.[6]

Clinical Clerkships

The standardized patient program director should utilize the SOBP developed by ASPE to assist the educators in pursuing and assuring continuous improvement in training and education. Case development, domain two of ASPE’s SOBP, suggests that it is the development and design of the simulation materials and the evaluator training that are the critical aspects of any SP-based activity.[3]

SP simulation cases have multiple components depending on who is going to use the case and are best developed by utilizing best practice guidelines relevant to the profession, including those outlined by the International Nursing Association for Clinical Simulation and Learning (INACSL) Standards of Best Practice for Simulation. Using INACSL standards of outcomes and objectives will ensure that the case aligns with the measurable learning objectives. Expertise by the SP educator is critical in the development of evaluation tools, the teaching of case-related materials used by the SPs, the logistical design of the cases, and the overall implementation.[12]

Case components and preparation are the two principles that guide SP case development. The standardized patient program director should ensure the simulation case has objectives and goals that are clear and can be assessed. As SP cases may support both large-scale mass casualty scenarios and intensive inter-professional simulation training activities, SP training and case review are paramount to ensure successful implementation.[13][14] These same objectives and goals are to be specific to the level of the intended learner.[15]

The simulation design must be written to ensure it is repeatable and meets the intended purpose. Information for the SP must include the backstory and situation, demeanor and affect, signs and symptoms, history, and performance cues. Guidelines about debriefing and feedback state that this portion of the simulation exercise should be case-specific and provide instructions to learners, with a time-frame that allows discussion of all relevant portions of the activity and learner performance. SP components for learner evaluation can include rating scales or checklists as instruments to measure performance. Protocols for the SP rating of learners should be part of their training.[3]

In preparing the material, subject matter experts are to be identified and engaged to assist in the creation of case content. The standardized patient program director must ensure that the individuals represented are respected to avoid stereotyping, or bias on marginalized populations and the cases are based on authentic problems.[16] Appropriate time must be allowed for case development to draft, edit, and review the case material before implementation. Having piloting processes or dry-runs can help to address any changes needed before implementation. Managing the data and documents are also part of the responsibility of the SP program director.[3]

Procedural Skills Assessment

Practicing specific procedural skills is often deferred to task trainers. However, it may be appropriate to perform these training activities with manikins and/or standardized patients, especially when the training focuses on empathy and ergonomics for the skill itself.[17] Invasive or painful procedures are not expected to be a component of routine function for SP training, but commonly hybrid training roles for procedural skills are conducted.[18] In these hybrid activities, SPs may wear a piece of simulation technology such as a task trainer to enhance the realism for the learner in positioning and technique.[19] Some more advanced task training devices may even provide feedback to the SP who is wearing it. This feedback will signal the SP to respond to an action performed by the learner, such as catheter insertion at a specific depth.

Although uncommon, some medical schools and residency programs use SPs for invasive procedures for teaching, evaluating, and demonstrating the proper technique for female and male genitourinary (GU) examinations. These standardized patients are also known as Genital Teaching Associates or GTAs. It is the responsibility of the SP program director to ensure that these activities are performed in a clinical examination room that is appropriately equipped and under the supervision of a clinical instructor.[20]

Clinical Significance

Performance-based simulation is now widely accepted as a form of effective simulation training based on the experience of training in military settings, mass casualties, nuclear power plant operations, and the aerospace industry.[21][22][13] National licensure and/or certification high-stakes exams utilizing standardized patients now exist in the United Kingdom and Canada. International medical graduates seeking certification are now being tested on clinical skills utilizing standardized patients by the Educational Commission for Foreign Medical Graduates (ECFMG) to enter residency programs in the United States.[23] The National Board of Medical Examiners (NBME) developed a similar program that is now used by the United States Medical Licensing Examination (USMLE).[24]

The NBME endorses the standardized patient’s report as a primary evaluation tool and as a basis of scoring in the assessment of clinical skills of students and candidates. Using standardized patients in multiple station sessions has contributed to the understanding of moving from paper and pencil knowledge tests to performance-based assessment and teaching. Clinical skills can be evaluated and/or taught with the use of SP encounters in a standardized, systematic, and quantifiable manner. Interpersonal skills, diagnostic abilities, communication, patient management, physical examination maneuvers, and medical history interviews can be objectively itemized as necessary and scored. Formative educational opportunities can be provided in medical schools with the use of outstanding realistic SPs in high stakes testing.[6] 

Research has shown that OSCE scores can be reliable, and results can help to improve the medical school curriculum. Multiple sessions and raters can improve the reliability of the assessment of a learner’s performance. Interrater reliability should be assessed to ensure consistency of grading of the same activity. The SP director should help coordinate SP and external observer activities and review the consistency and agreement of assessments by these individuals. Standardized patients can add to the ability to evaluate learners if the SP program director and the content expert can appropriately define the expected performance criteria and train the SP in assessing these skills.[6][25]

Pearls and Other Issues

The integrity and sustainability of an SP program can be maintained by following the standards of best practice set forth by professional societies of health care simulation. There is ongoing research on the growing interest and impact on learner performance and assessment from using SPs to improve curriculum outcomes.

A standardized patient program can meet institutional goals and enhance learner education, but it must be maintained and guided by a standardized patient program director who is engaged and knowledgeable about simulation and the importance of the SP role.

Enhancing Healthcare Team Outcomes

Research shows interprofessional teams are participating in standardized patient scenarios that deal with difficult conversations with patients. These interdisciplinary teams can consist of residents, student nurses, medical students, and pharmacology students, among many others.[14] 

Standardized patients as embedded participants and as subjects of clinical care can provide a robust opportunity to train communication skills in an interprofessional setting. Despite technological advances in many other areas of healthcare simulation, this authentic interpersonal communication cannot be simulated through other modalities at this time.