Many times patients in general medical intensive care units (ICU) need mechanical ventilation support. The 2002 clinical practice guidelines of the Society of Critical Care Medicine (SCCM) for the sustained use of analgesics and sedatives are geared toward the preservation of optimal comfort for critically ill patients by concentrating on pain and anxiety. In order to achieve alleviation of pain and anxiety, the SCCM recommends use of protocols to titrate medications to a defined endpoint such as pain free, calm and alert.
This endorsement is based on evidence from admirable outcome investigations and is best accomplished by means of validated pain assessment and sedation scales (Pun, Gordon, Peterson, & al, 2005). Unfortunately not all medical facilities have implemented these recommendations and many patients continue to be over and under sedated related to not instituting a standardized sedation assessment scale. Purpose
The purpose of this study is to determine if the Nursing Instrument for the Communication of Sedation (NICS) yield more accurate or appropriate sedation assessment than individual nursing judgment in an effort to build support for its use as a sedation assessment tool among adults in general medical ICU’s that are mechanically ventilated. Background and Significance to Nursing Many adult critical care patients require mechanical ventilation to combat many disease processes and traumatic injuries.
Most patients requiring mechanical ventilation are treated with sedative mediations such as opiates, benzodiazepines and propofol. These are given for a wide range of indications that is best summarized as reducing the physiological and psychological stress of the disease process that warrants mechanical ventilation and to improve the tolerance of the invasive life support itself. Some studies have demonstrated the use of sedation assessment scales and protocols to minimize sedative exposure and maximize sedation accuracy (Weinert & Calvin, 2006).
Nursing is the dominant executions of such protocols as well as the administrating clinicians of the sedative medications. In the time before use of standardized sedations scales and still in some facilities today, nurses drew from their own individual judgment to determine the amount of sedative to give. Statement of the Problem Even though the SCCM recommends the use of sedation scales many facilities have yet to implement the use of such scales relying solely on individual nursing judgment with variable descriptors to communicate the state of sedation that a patient is under.
Three main problems exist when relying on individual nursing judgment. Nursing judgment does not offer congruency of sedation from shift to shift when nursing assignment changes, it does not allow for effective recording of the current sedative state, and is not efficient for communicating sedative levels with patient hand off. Unfortunately, only one third of American universities, comprising the University Hospital consortium, reported using sedation protocols and scales (Pun, Gordon, Peterson, & al, 2005). For these reasons, many patients are over or under sedated.
Weinert & Andrew (2006) concluded that although patients were minimally arousable or non arousable nurses rated patients as under sedated suggesting that individual nursing judgment leads to high amount of over sedation. Not fixing the current situation cost each facility in the millions of dollars each year from cost stemming from extended length of ICU stays not to mention the suffering to the patients themselves. Research Question/Hypothesis Therefore this study poses the question, for adult ICU patients, does the NICS yield more accurate or appropriate assessment information than individual nursing judgment about LOA?
It is the hypothesis of the researchers that use of the NICS will return more accurate sedation information than individual nursing judgment about LOA. Conceptual Framework Historically, before the study of sedation scales as assessment tools, nurses almost always used their own nursing judgment to titrate sedative medications, record and communicate sedation levels and such is true at the proposed testing facility. As still holds true today, many nurses are intolerant to change from what they are accustom to.
This study follows Prochaska and Velicer’s Transtherietical (Stages of Change) Model (1997) to allow for successful transition of the nurses to utilize the NICS. The core construct around which the other dimension are organized are the stages of change, which conceptualizes a continuum of motivational readiness to change problem behavior. The five stages of change are pre contemplation, contemplation, preparation, action and maintenance. Transitions from one stage to the next are affected by processes of the change.
The model also incorporates a series of intervening variable, one of which is self-efficacy (Polit & Beck, 2012). Definitions Sedation levels are measured per the NICS, LOA and are conceptually and operationally defined in table 1 and 2. Individual nursing judgment is without definition and relies solely on the nurses individual definitions of various sedative levels. Table 1 Nursing instrument for the communication of Sedation NICS [pic] Table 2 Level of Arousal [pic] Assumptions The researchers assume that the derived scores would be the same at any facility. Limitations
There are limitations of this study in the form of being performed at only one facility. Additionally the utility of the NICS is optimized during conscious sedation, where deviation from zero to a +2, +3 or -2, -3 may bear some correlation to need for patient attention. In other common ICU scenarios, the sedation goals may target more diminished LOA (NICS -2, -3) to improve critical care management. The testing although occurring equally among both the NICS and the individual nursing judgment is brief and may not imply correlation over longer periods of time. Summary
The researchers are interested in identifying the accuracy of the NICS over that of individual nursing judgment on sedation assessment. With many ICU patients requiring mechanical ventilation the need for a more accurate sedation technique is paramount in reducing hospital cost and patient suffering. Nursing plays a vital role in administering and recording sedation levels and is the key player in weather or not the patients are accurately sedated during mechanical ventilation. Nurses have been using individual judgment as a means to guide sedation titration for quite some time and are reluctant to change.
Prochaska and Velicer’s Transtherietical (Stages of Change) Model (1997) will be adapted and utilized to foster successful change during training and implementation of the NICS for those nurses who are involved in the study. Measurements and level of sedation are conceptually and operationally defined utilizing and ordinal measurement as a means to test correlations. The assumptions and limitations have been disclosed. Chapter 2: Review of the Literature Introduction A review of the literature reveals that several scoring systems are in use in the ICU to categorize patients’ level of arousal.
Such sedation scales are principally used by nurses as a tool to record in ordinal fashion the patients’ physical condition and to be used as a guide to monitor and titrate pharmacologic sedation. This area of practice has gained considerable recent attention in order to optimize patient care and outcomes. (Weinert & Calvin, 2006) Relevant Literature for each Study Variable A study conducted by Mirski, et al. (2010) tested the validity and reliability of the NICS. The researchers found the NICS to be a reliable and valid tool for ease and simplicity of communicating sedation levels among providers.
The researchers concluded that the NICS was preferred over some of the more popular sedations scales due to its ease to commit memory and effectiveness for accuracy in the assessment of sedation. (Mirski, Ledroux, Lewin III, Thompson, Mirski, & Grisworld, 2010) LOA descriptors have been used extensively amongst the health care profession so much that they have become generally accepted amongst the medical community. The descriptors are what are used in general by individual nurses to describe sedation levels of their patients.
However, the definitions of the descriptors are not universal amongst nurses and therefore in lay the problem. LOA descriptors have been defined by the researches to better operationalize and correlate them with the NICS (Mirski, Ledroux, Lewin III, Thompson, Mirski, & Grisworld, 2010) (Pun, Gordon, Peterson, & al, 2005). Although individual nursing judgment has been utilized as a means to assess and record level of sedations among mechanically ventilated patients in the ICU, it is not efficient, validated or reliable.
Studies show that although patients are unarousable or minimally arousalable, nurses many times record the patients as under sedated (Weinert & Calvin, 2006) Relevant Literature for Selected Framework Historically, before the study of sedation scales as assessment tools, nurses almost always used their own nursing judgment to titrate sedative medications, record and communicate sedation levels and such is true at the proposed testing facility. As still holds true today, many nurses are intolerant to change from what they are accustom to.
This study follows Prochaska and Velicer’s Transtherietical (Stages of Change) Model (1997) to allow for successful transition of the nurses to utilize the NICS. The core construct around which the other dimension are organized are the stages of change, which conceptualizes a continuum of motivational readiness to change problem behavior. The five stages of change are pre contemplation, contemplation, preparation, action and maintenance. Transitions from one stage to the next are affected by processes of the change.
The model also incorporates a series of intervening variable, one of which is self-efficacy (Polit & Beck, 2012). Synthesis of Findings It is evident from the literature review that sedation scales should be utilized to guide sedation medication administration, communicate between healthcare providers and record sedation levels. One obstacle to instituting a standardized model is nursing reluctant to change. Prochaska and Velicer’s Transtheoretical Model is a good framework to adapt and instate change in he nursing behavior in order to foster acceptance of the use of the NICS over individual nursing judgment. Gaps Identified While studies have been done validating and confirming reliability of the NICS no studies have compared it with individual nursing judgment. Furthermore studies have been executed demonstrating the lack of validity and reliability of individual nursing judgment but few studies have compared individual nursing judgment with a reliable and validated sedation scale and none comparing nursing judgment with the NICS. Summary
A comprehensive review of the literature reveals that the NICS is a validated and reliable sedation assessment tool with preference among nurses when compared to other standardized sedation scales for its simplicity and accuracy (Mirski, Ledroux, Lewin III, Thompson, Mirski, & Grisworld, 2010). The LOA descriptors have been employed by medical profession for decades to describe sedation levels and are generally accepted (Pun, Gordon, Peterson, & al, 2005). Individual nursing judgment has been shown to be inaccurate and inefficient in assessing and communicating sedation levels (Pun, Gordon, Peterson, & al, 2005).
Prochaska and Velicer’s Transtheoretical Model has been used as a means to promote successful healthcare change and can be adapted to promote successful change amongst nurses reluctant to change from individual nursing judgment to using the NICS scale (Polit & Beck, 2012). Chapter 3: Methods Introduction A Quasi- experimental design is chosen for this experiment due to the controlled nature of this experiment without randomization. The study is performed at a Level II trauma center in the general medical ICU. Only adult mechanically ventilated patients that are ventilator dependent for a inimum of 24 hours will be included. The sample is divided into an experimental group (NICS) and a control group (individual nursing judgment). The entire study takes place over a 1 year period with an estimated sample sized of 500 subjects. A panel of experts will collect the data from both the experimental (NICS) and control group (individual nursing judgment) and score the assessment with LOA ordinal assessment blindly to other panel members at initiation of sedation, 30 minutes after induction, then every four hours for 24 hours.
The expert’s scores will then be compared by correlation to that of the assigned nurses’ score of both the experimental group and control group. All Nurses selected for the experimental group is provided rigorous training on the NICS scale. Protection of human subjects is ensured by assigning an identification number rather than attaching personal information to the data. Informed consent will be gained either from the subject study themselves or a legal representative. The study has is approved the internal review board. Design
A Quasi- experimental design is chosen for this study due to the controlled nature of the study without randomization. This type of design was chosen because of its fit to the research question that includes a control group without the intervention of using the NCIS and an experimental group using the NCIS as an intervention. Population & Sample The sample for this study would include all adult patients admitted to general medical ICU at SJMC over a 1 year time period in which mechanical ventilation and sedation is indicated.
Exclusions from the study include medical disease states such as Acute Respiratory Distress Syndrome (ARDS) severe head injury tetanus. To gain a power analysis of . 8 yields the need for a sample of 500 subjects that is large enough to support the hypothesis. Recruitment of subjects is accomplished by generating a screening tool on admit with a representative speaking face to face with the subjects or the subjects families to obtain permission conveying courtesy, persistence, enefits, offering to share the results, explaining the convenience and necessity of the study . Incentives such as food stipends and housing would be offered to patients and families who participate in the study. Assurances would be made of how the data collected would be used and that confidentiality would be maintained. The fore mentioned sampling plan is consistent with the research question as it involves subject in the ICU requiring mechanical ventilation and sedation. Data Collection Procedures
A team with experience in assessing LOA, agitation, and anxiety comprised of a neurology specialist, pharmacist, and ICU RN will collect the data from both the experimental (NCIS) and control group (no standardized scale) and score both groups using the NICS and giving a rating of -3, -2, -1, 0, 1, 2, 3 at initiation of sedation, 30 minutes after induction, then every 4 hours for 24 hours. Each experienced panel member will be blinded of the all other panel member scores. Expert panel scores will then be correlated with the assigned nurses’ scores from both groups utilizing Spearman’s rho (rs).
The expert panel members and selected nurses that will be implementing the NCIS will be provided with classroom training on how to use the NCIS and the procedure to assess and assign scores on the numerically identified card and return to the head researcher. LOA, agitation and anxiety assessment will not be taught as the individuals are already experienced. A written training manual will also be provided with written collection protocols provided as well as general instructions, specific instructions and copies of all data forms. Instruments The NICS and the LOA assessment tools are demonstrated in table 1 and 2 above.
Control Methods .It is possible that the bias be introduced during data collection by many different avenues including Researcher subjectivity, sample imbalances, faulty data collection tools, and flawed implementation. However, strategies to combat bias are implemented such as using blinded expert panels, pretesting instruments used, and rigorous training of researchers. Statistical Analysis/Coding Procedures Statistical analysis of correlation, Spearman’s Rho is performed utilizing a widely accepted statistical software package, Statistical Package for the Social Sciences (SPSS) by an expert user.
Both the NICS and LOA are assigned an ordinal measurement as depicted in table 1 and 2. Protection of Human Subjects An approval form is prepared and submitted to the Institutional Review Board (IRB) for approval. Special care is taken to explain the following on the application: •Risk to participants are minimized •Risk to participants are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result •Selection of participants is equitable •Informed consent will be sought, as required, and appropriately documented. Adequate provision is made for monitoring the research to ensure participants’ safety. •Appropriate provisions are made to protect participants’ privacy and confidentiality of the data. •When vulnerable groups are involved, appropriate additional safeguards are included o protect their rights and welfare. Individuals of the study will be assigned an identification number rather than attaching personal identifying information to the data. All data will be kept confidential and only those researches with a need to know will be informed of identity.
All identifying information on data gathered will be stored on an external Sans Disk Card and locked in the office of the head researcher taking special care not to save any identifying information to any personal computers or hard drives. All sensitive and identifiable information will be destroyed as soon as feasibly possible. Informed consent will be obtained communicating the following information to participants or participant’s legal representatives: •Participant status •Study goals •Type of data •Procedures •Nature of the commitment Sponsorship •Participant selection •Potential Risk •Potential Benefits •Alternative •Compensation Confidentiality pledge •Voluntary consent •Right to withdraw and withhold information •Contact information All consent forms will be explained to the participants or the participants legal representative by a research assistant upon admit to the Intensive Care Unit (ICU). Additionally a separate authorization to access private health information will be sought from the participant or participant’s legal representative. Summary
In conclusion, A Quasi- experimental design is chosen for this experiment without randomization but involving a control group. The study is performed at a Level II trauma center in the general medical ICU. Only adult mechanically ventilated patients that are ventilator dependent for a minimum of 24 hours will be included. Exclusions include patients with diseased states that require heavy sedation or paralyzation. The sample is divided into an experimental group (NICS) and a control group (individual nursing judgment). The entire study takes place over a 1 year period with an estimated sample sized of 500 subjects.
A panel of experts will collect the data from both the experimental (NICS) and control group (individual nursing judgment) and score the assessment with LOA ordinal assessment blindly to other panel members at initiation of sedation, 30 minutes after induction, then every four hours for 24 hours. The expert’s scores will then be compared by correlation to that of the assigned nurses’ score of both the experimental group and control group. All Nurses selected for the experimental group is provided rigorous training on the NICS scale.
Protection of human subjects is ensured by assigning an identification number rather than attaching personal information to the data. Informed consent will be gained either from the subject study themselves or a legal representative. The study has is approved the internal review board. References Mirski, M. A. , Ledroux, S. N. , Lewin III, J. J. , Thompson, C. B. , Mirski, K. T. , & G. M. (2010). Validity and reliability of an intuitive conscious sedation scoring tool: The nursing instrument for the communication of sedation. Critical Care Medicine, 38(8), 1674-1684. Polit, D. F. & Beck, C. T. (2012). Nursing Research: generatiing and ssessing evicence for nursing practice. Philadelphia: Wolters Luwer Health|Lippincott Williams & Wilkins. Pun, B. , Gordon, S. , Peterson, J. , & al, e. (2005). Large-scale implementation of sedation and delirium monitoring in the intensive care unit: A report from two medical centers. CRITICAL CARE MEDICINE, 33(6), 1199-1205. Weinert, C. R. , & Calvin, A. D. (2006). Epidemiology of sedation and sedation adequacy for mechanically ventilated patients in a medical and surgical intensive care unit. CRITICAL CARE MEDICINE, 35(2), 393-401.
