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Introduction

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The importance of both short-term and long-term outcomes after major trauma has become of global concern due to the ongoing development of sophisticated trauma care (Holbrook et al., 1999, p.768). There is, however, little research that focuses on the meaning of motor vehicle accident (MVA) survivors two months after discharge. On the contrary little is known to have an empirical foundation to guide the understanding of the phenomena.

It is therefore hoped that this qualitative study will provide an understanding on the experiences that the Motor Vehicle Accident survivors undergo after the incident and also during therapy (Blanchard et al , 2004, p. 577). Although many experiences of trauma patients have been described in literature, no information has been found to describe the patients’ experiences using a grounded theory approach (Shih et al , 2010 , p.7).

The qualitative protocol of grounded theory method will be employed to produce a detailed description and theoretical analysis of the Motor Vehicle Accident survivors’ experiences (Blanchard et al , 1995, p. 498). This methodology provides a thorough way to develop an understanding of the experience of Motor Vehicle Accident survivors from the patient’s perspective. This perspective will help in enhancing knowledge and a defined understanding to those living with the experience (Glaser and Straus, 1967, p.115).

The overall goal of this study is to develop a more complete description of the phenomenon and the process that the individual undergoes after a Motor Vehicle Accident (Blaszczynski et al , 1998, p. 120). Grounded theory comes in hand particularly in areas of research where there is less information known about the incident or case on study. Through the approach of grounded theory, researchers are able to develop a deeper comprehension and understanding of the patients’ experiences despite the little information provided (Glaser, 2001, p.87). This methodology is thus a big contribution to the nursing development of a substantive body of knowledge. “Most importantly the developments of theories of the middle range that are empirically tested as well as guiding the nursing practice.” (Streubert-Speziale & Carpenter, 2007, p. 102)

Henceforth, the main purpose of this qualitative study is to generate an empirically derived substantive theory of the experience of motor vehicle accident survivors two months after discharge from the health care facility (Blanchard et al , 2004, p. 577). This protocol will describe the participant’s recruitment plan, in addition to this; data for the study will be collected through one-on-one interviews lasting for approximately one hour. The Data will then be transcribed verbatim, while analysis of data will be done using constant comparison techniques (Shih et al , 2010 , p.7). This qualitative study is important for theoretical basis of enhancing nursing knowledge, thus it will be useful to policy makers, hospital administration as well as trauma services.

Background and Significance

Evidence collected from past research shows that individuals hospitalized after physical traumas are at more risk of depression (Davydow et al, 2009, p.801). The Depressive symptoms are common in general ICU survivors and have a negative impact on the quality of life of the patient after the incident (Davydow et al, 2009, p.801). “This occurs especially in symptoms of depression two months post-ICU strongly predict depressive symptoms at 6 months post-ICU.” (Davydow, 2009, 803)

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In one large prospective epidemiologic study ‘The Trauma Recovery Project’ (TRP), Holbrook et al. (1998; 1999) conducted this study to examine the multiple outcomes that arise after major trauma in adults aged 18 years and older. The study included quality of life, functional outcome, and psychological conditions such as depression and posttraumatic stress disorder (PTSD) (Kelley et al, 2003, p. 112).

The researchers assessed patients’ outcomes at discharge and at 6, 12, and 18 months after discharge. The specific objective of this study was to describe functional outcomes at discharge and 6-month follow-up time points in the TRP population as well as examining the interaction of recognized risk factors with functional outcome (Kelley et al, 2003, p. 112). The Findings of this study revealed that post-injury functional limitation is a clinically significant complication in trauma patients at discharge and 6-month after on follow-up (Ohzato et al , 1993, p. 145).

The researchers thus concluded that post-injury depression (PTSD), serious extremity injury, the period of stay in the intensive care unit have a significant impact on quality of well-Being outcome (Holbrook et al., 1998, p.315). This was the first report that provided novel and challenging evidence that the importance of dysfunction after major injury had been underrated (Holbrook et al., 1998, p.323).

Research in the field of Psychoneuroimmunology indicated that there is an existence of reciprocal communication pathways between the nervous, endocrine and immune systems (Schiepers et al, 2005, p.67). This has therefore led to an increasing interest in the involvement of the immune system in psychiatric disorders (Dantzer, 2003, p.252). The research has indicated that these reciprocal connections between the nervous and immune systems are essential to understand the underlying pathophysiology of depression (Segal et al , 1997, p.45). More so, pro-inflammatory cytokines such as IL-6 play an important role in developing depression and can arbitrate its psychological, behavioral and neurobiological expressions (Dantzer et al, 2010, p.28).

“The cytokine hypothesis of depression recommends that external psychological stressors and internal organic inflammatory diseases or condition stressors induce inflammatory process” ( Wichers & Maes, 2002, p.377). Additionally, it has been shown through research that psychological stress might initiate an inflammatory response if the production of pro-inflammatory cytokines is high (Maes et al, 1999, p.836).

“Cytokines had been found to induce behavioral changes connected to some symptoms of depression thus causing neuroendocrine changes in animals similar to those in depressed patients.” (Dantzer et al, 2002, p.501). As a matter of fact, it has been found that administration of cytokines could induce alterations in the brain similar to those experienced by depressed patients (Maruszynski and Pojda, 1995, 883). This deduction made researchers hypothesize that “cytokines induce depression by their influence on the 5-HT, noradrenergic and HPA system” (Wichers and Maes, 2002, p.385). Biffl and his colleagues (1996, p.652) summarized the properties of IL-6 and characterized its response to injury.

There are also clinical studies that describe the IL-6 response to trauma (Ayala et al, 1991, p. 68). However, despite the fact that IL-6 is considered to be a mediator of the physiologic, “short-term phase reaction to injury, excessive and prolonged post injury elevations are associated with increased morbidity” (Gebhard et al, 2000, p.294). Cytokines are key regulators of the immune response (Elenkov and Chrousos, 1999, p.587).

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However, “the result of a hyperactive proinflammatory state marked by excess production of proinflammatory cytokines like IL-1, IL-6 and TNF and IFN gamma may contribute to the pathogenesis of various human diseases such as allergy, autoimmunity, obesity, depression and atherosclerosis” (Sternberg, 2006, p.320). Theory shows that cytokines released in response to an infection or inflammation alert the brain of any possible threats thus inducing behaviors that are thought to be important for survival (Frink et al, 2009, p.33). Some people have even gone further to classify the ability of the immune system to alert or communicate with the brain as the “sixth sense” (Blalock & Smith, 2007, p.31).

“Sickness behavior is believed to be adaptive in that it forces an individual to rest and withdraw from activities so that physiological processes can more effectively produce healing” (Blalock & Smith, 2007, p.33). It is now confirmed that proinflammatory cytokines produced in cases of infection, inflammation, injury and even psychological stress are able to signal the brain to induce behavioral changes that fight back these threats (Shapira-Lichter et al , 2008, p.389). And as mentioned earlier, cytokine-to-brain signaling has been implicated in mood disorders, particularly the depression that comes in hand with illness (Dantzer, 2009, p.250).

After reviewing the literature, there seems to be a gap between what trauma patients go through after the release of proinflammatory cytokines and their functional outcomes, psychological status and depression (Kremer et al, 1996, p. 268). This calls for the need to understand the experience of the trauma survivors after discharge and after the release of proinflammatory cytokines (Steptoe et al , 2007, p. 908). There is little research if any, that focuses on the meaning of motor vehicle accident survivors two months after discharge (Maes, 2009, p.42). Therefore, the purpose of this qualitative study is to generate an empirically derived substantive theory of the experience of motor vehicle accident survivors two months after discharge.

Research Design and Methods
Research design

In this qualitative study, grounded theory method will be employed to produce a detailed description and theoretical analysis of the MVA survivors’ experience (Schnyder et al , 2010, p. 654). This methodology provides a thorough way of developing an understanding of the experience of MVA survivors from the patient’s perspective. This perspective will help in enhancing the knowledge and understanding to those living with the experience (Glaser & Straus, 1967, p.78). The overall goal of this work is to develop a more comprehensive description of the phenomenon and the experience that an individual encounters after a Motor Vehicle Accident (Glaser & Straus, 1967, p.78).

Grounded theory is particularly useful in focusing on areas of research where there is little information (Glaser & Straus, 1967, p.79). Thus, this methodology offers essential contributions to the nursing development of a substantive body of knowledge, most importantly the development of middle range theories that are empirically tested to act as guides in the nursing practice (Streubert-Speziale and Carpenter, 2007, p.98).

Sample and sampling plan

This Grounded Theory study will recruit approximately 20 participants. This is a convenient sample of trauma patients specifically the MVA survivors between the ages of 21 and 50 years who are admitted to Loyola University Medical Center, Maywood Illinois. A convenient sample in clinical research is one that is made up of individuals who meet the entry criteria and investigator has ease of accessing them (Hulley et al, 2007, p.165). Nevertheless, efforts will be made to recruit a representative sample (Hulley et al, 2007, p.165).

Therefore, the inclusion criteria are poly-traumatized patients from MVA with an injury severity score (ISS) ≥ 16, who are alert, oriented, read, write and speak English and are willing to participate in the study (Mosmann and Sad, 1996, p.143)). Patients will be recruited when being prepared for discharge. Eligible subjects will be identified in collaboration with attending physicians and/or their designated staff. Participant exclusion criteria includes persons who had a history of depression or any stressful events before the trauma, persons who are unable to communicate effectively in English or are unable to provide narrative data required for the study (Hulley et al, 2007, p.165). The final number of participants will be determined by the evidence of saturation of data for key concepts.

Recruitment plan
The Setting of the study

A convenience sample of trauma patients will be recruited from the department of surgery at a large urban academic health center in the Midwest. The department of Surgery Trauma Services is located in Maywood, Illinois, a suburban part of Chicago. The Loyola University Medical Center campus will serve as the primary recruitment site for all the study participants. Interviews will be conducted two months after the patient has been discharged, at a time agreeable to both the participant and interviewer. One on one interview will last approximately one hour. Interviews will be audiotape recorded and transcribed verbatim.

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The Study Procedure

The trauma nurses in the department of surgery will approach trauma patients regarding participation in the study. If the traumatized patient expresses interest in the study, the trauma nurse or the nurse in charge will notify the investigator. The investigator will in turn visit the trauma patient in LUMC to briefly describe the study and explain to the patient that the next arranged meeting would be at their time of discharge. The trauma surgeon or the nurse in charge of the unit will be informed that the investigator should be notified when the discharge order is issued to the patient.

At discharge, Mrs. Nasser, the primary investigator (PI), will approach the potential participants, fully explain the study protocol and purpose, and invite the motor vehicle accident survivors to participate in the study. If they are interested in joining the study, the PI will obtain an informed consent and enroll the patient in the study. The time of enrolment will be designated as (T1). At T1, the patient will complete general health history and demographic data forms (Hulley et al, 2007, p.165). The patients will be asked to come back after two months of post discharge (T2) for a one on one interview on a specific date according to the patient’s convenience.

The PI will be responsible for conducting the interviews. Thereafter, the patient will be given contact numbers of the investigator in case they want to withdraw from the study, or if they have further questions about the study or are unable to come back to LUMC and would like the investigator to meet them at home for their convenience (Hulley et al, 2007, p.165). Participants will receive a reminder call from the investigator a week before the pre-arranged second meeting (T2). MVA survivors enrolled in the study will be seen after two months of discharge (T2) either at LUMC or at the patient’s home whereby they will be engaged on a one on one interview. Patients who come back for the T2 will be given $50 as compensation for their transport and time.

Data collection and Data analysis

In grounded theory, data collection and analysis occur simultaneously (Glaser and Strauss 1967, p. 213). First and foremost, the investigator will listen to the recorded interview tapes several times and the data transcribed verbatim. Next, will be the line-by-line in vivo coding. Analysis of data will be done using constant comparison techniques for the derivation of substantive concepts (Rubin and Rubin, 2005, p. 143). The linkage between concepts will be verified for the generation of the substantive theory.

Data will be simultaneously collected and analyzed using constant comparison methods to facilitate the identification of concepts and patterns. Concepts, categories as well as subcategories will be identified. Thus, the basic properties of each concept will be defined; the relationships between the concepts identified, and the properties and conditions explicitly clarified. Theoretical sampling is a process of data collection which is controlled by the emerging theory (Glaser and Strauss 1967, p.76). The investigator will identify negative cases that do not fit within the scheme by using theoretical sampling to increase the validity of the study.

Constant comparison methods, asking questions, and keeping memoranda and diagrammatic records will be done concurrently from the onset of data collection until theoretical saturation is achieved (Rubin and Rubin, 2005, p. 143). “Theoretical saturation is the criterion used to determine when to stop recruitment. This is achieved through a combination of the empirical limits of the data, integration of the theory, and theoretical sensitivity.”(Glaser and Strauss 1967, p.102) This in return enhances the reliability of the study.

Translation of findings

“Grounded theory methodology is used to discover new dimensions of the social processes that play in people’s lives.” (Streubert-Speziale and Carpenter, 2007, p. 143) Therefore, when new dimensions are discovered, it will be the researcher’s responsibility to publish the findings obtained (Streubert-Speziale and Carpenter, 2007, p. 143). It is expected that this qualitative study will provide quantitative research with substantive categories and hypotheses. Thereafter, the quantitative research will further explore the aim of testing the derived theory and discover facts accordingly (Glaser and Strauss 1967, p. 105).

After the study is completed findings will be shared with the participants to ensure that they view themselves and their world in accordance to the investigator’s findings. Then professors at Loyola University will review the manuscript thereafter, the manuscript will be edited according to their recommendations.

Protection of Human Subjects

An approval form from the Loyola University Medical Center (LUMC) Institutional review boards (IRB) for conducting this study will be obtained. “Federally or government sponsored studies are subject to strict guidelines for evaluation and before undertaking any study” (Polit and Beck, 2008, p. 78). “Therefore researchers need to submit their research plans to the IRB, and must also go through a formal human subjects training and certification process which can be completed online” (Polit and Beck, 2008, p. 78). The responsibility of the IRB is to ensure that the proposed plans meet the set requirements federal for ethical studies (Polit & Beck, 2008). The study and informed consents will be reviewed by IRB at LUMC for the Health Insurance Probability and Accountability Act (HIPPA) compliance.

Another important procedure for safeguarding participants of the study and protecting their rights to self-determination involves obtaining their informed consent (Polit & Beck, 2008, p. 98). An informed consent makes sure that the participants have adequate information regarding the study. It also ensures that they are able to comprehend the information and have the power to choose to either participate or to decline their participation in the study voluntarily (Polit & Beck, 2008, p. 98). Therefore, informed consent will be obtained from all study subjects prior to participation in the study by the primary investigator.

All study materials will be printed in English, and all study subjects should be capable of reading and writing in English (Polit & Beck, 2008, p. 106). The informed consent will include significant study information that includes outlining the purpose of the study, and addressing the duration of participation of one hour in time commitment. An example of an informed consent form is included in the Appendix.

One of the key strategies researchers use to protect participants is looking at the costs and benefits of the study, or the risks and benefits of the study (Schnyder et al , 2010, p. 654). This study is a minimal risk project with no benefits to participants. “Minimal risk is defined as risk anticipated being not greater than those ordinary risks encountered in daily life or during routine physical or psychological examinations and procedures.” (Polit and Beck, 2008, p. 143)

In this study, participants could encounter minimal risk through loss of interest, psychological or emotional distress resulting from sharing their personal information and being observed by the investigator. It can also be manifested through feeling uncomfortable around a stranger (for example the investigator) or embarrassment resulting from the type of questions asked in the interviews.

Loss of time and money are two other potential risks due to the cost of transportation (Polit & Beck, 2008, p. 243). In order to minimize and protect the participants against the risk, the investigator will clearly describe the study to the patient and obtain an informed consent from all participants. All participants will be given the investigator’s contact numbers and will be notified that they have the right to withdraw from the study at any time, and that there are no obligations to stay in the study if they are not willing to. Regarding the loss of money and time, as mentioned earlier, the participants would be compensated by $50 for time and transportation. Additionally, the investigator’s qualification is essential in minimizing the risk. It is important to ensure that during the interview that the patient is not harmed in any way.

Although this is a no-benefit project as it will be clearly and explicitly explained to the participants, the risks to subjects are reasonable in relation to the anticipated benefits to the trauma populations in the future. It is hoped that results from this study will help the Motor Vehicle Accident survivors (Streubert-Speziale & Carpenter, 2007, p. 209). Findings may stimulate policy makers and hospital administration especially on trauma services to develop and implement programs for early interventions with these trauma patients for better quality of life.

Most importantly, the researcher should maintain the confidentiality and anonymity at all times with all participants. This is done In order to ensure confidentiality. Additionally, all the taped and transcribed interviews will be kept in a locked cabinet during the study, and then within a year after completion of the study they will be destroyed. Lastly, consents should be stored separately in order to maintain subjects’ anonymity.

Trustworthiness of the study

Attention should be paid to maintaining trustworthiness throughout the research process. The investigator will ensure trustworthiness in the data by listening and transcribing the tapes, reading and reviewing the transcriptions. This should be followed by conceptualizing, understanding and translating the findings. Prolonged engagement, persistent observation, member checking and expert review will enhance credibility of the data obtained (Streubert-Speziale & Carpenter, 2007, p. 209).

Adequate audit trail is essential to ensure that readers will derive similar conclusions. Honesty is another essential criterion that should be undertaken when representing the process of data analysis and interaction. As the researcher analyzes data individually, emergent concepts and linkages will be reviewed for consistency. The researcher will always consult the raw data for evidence of reconciling discrepancies. This process enhances the trustworthiness and credibility of the findings (Streubert-Speziale & Carpenter, 2007, p. 209).

Personnel

***, RN, MS, Primary Investigator – The primary investigator is currently enrolled in the Nursing PhD program at *** University, Chicago. The student’s work will be under the supervision of ***, PhD, RN, FAAN. Mrs. *** is currently completing a course in qualitative research methodology. She will generate the list of potential participants and coordinate schedules for the interviews. She will be conducting interviews, collecting and analyzing the data as well as preparing the resulting manuscripts.

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