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Few successful programs of clinical research have been described at conferences or in publications.1,8,9 Those programs that do exist are unique and, unfortunately, scarce. In addition, the reason some programs are successful and others are not is not easy to extract from the literature. Some authors10–13 have noted the many barriers to clinical research. In fact, popular techniques and/or ways to encourage the development of clinical research programs that are mentioned commonly in the literature include the use of journal clubs, partnering with academicians, research mentoring by advanced practice nurses, and research classes.13–15 Unfortunately, none of these techniques have been studied in terms of their superiority, and despite their popularity, we still do not see many successful clinical research programs.
In this article, I describe the experience of a medical intensive care unit’s (MICU’s) 10-year clinical research program from the perspective of clinicians who have participated, and from my perspective as an advanced practice nurse (APN) who, in conjunction with administrative and clinical partners, developed the program. I describe the outcomes of the program and the components that have made the program a success. Although the more tangible process elements and program outcomes are important, perhaps more relevant are the less tangible reasons that the program has been successful. I think that clinical research is an important part of what we do and that the best way to encourage the development of clinical research programs is to integrate the wisdom gleaned from clinicians who have worked in a successful program. To that end, the experience of the clinicians and their descriptions of how their perceptions of clinical research changed from "research is for others" to "research is part of what we do" are recorded as quotations. I describe the process and guidelines used in the MICU for the clinical research program so that the context in which the clinicians do clinical research may be better understood. The focus of the article is not the research process (numerous books and articles are available that address that topic), but rather the context and characters responsible for making the program come alive.
THE MICU RESEARCH PROGRAM
The MICU is a 12-bed unit in a 535-bed academic medical center. The unit has a very high acuity (when units are ranked by the totals of the Acute Physiology and Chronic Health Evaluation III scores of their patients, the MICU has the highest total of all the ICUs in the hospital) and average staffing (generally 1 nurse to 2 patients). The clinical research program has enjoyed support from both the administration and the medical director during the 10 years it has been in place. These leaders think that clinical research is a necessary and important part of practice. Further, clinical research is seen as a recruitment and retention tool and a way to develop evidence-based practices in the unit. The leaders think that beneficial clinical and cost outcomes result from clinical research, and this notion has been confirmed by the clinical projects accomplished to date. Although the administrative managers have changed during the 10-year tenure of the program, in my capacity as the APN, I have been consistently present to guide and help develop the clinicians participating in the program.
THE INTERVIEWS
Nine MICU staff clinicians (8 nurses and 1 respiratory therapist) participated in a videotaped interview in April 1998 that I used as part of a presentation at the 1998 American Association of Critical-Care Nurses’ annual National Teaching Institute in Anaheim, Calif. Excerpts of the videotape were used in my presentation "Clinical Research: Part of What We Do." The clinicians participating in the interview responded to 6 questions. None had heard any of the questions before the interview. The questions and the responses of the clinicians are listed in Table 1
. Although the audiovisual taped responses are clearly superior to the written responses listed in the table, the clinicians’ enthusiasm for clinical research is still easy to discern. The participants articulate their initial perceptions of clinical research as being "something done by others" such as academicians. Before they came to the MICU and saw other clinicians participating in clinical research, these participants thought that research was "too hard" and "outside a practicing clinician’s scope of practice." But they also describe the things that made research "come alive" and become "part of what we do every day." Their comments indicate that they find clinical research rewarding, fulfilling, and empowering. These clinicians think that the work results in real changes in practice that help them take care of their patients better. In fact, they suggest that all clinicians should be doing research if the clinicians care about patients. Although every response is not recorded, the most representative responses are quoted. The rest of the article does not focus on the steps of the research process (they are assumed), but rather discusses the elements that were critical to the success of the program as described by the clinicians in their interviews.
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The philosophy of the unit is that anyone who wishes to do clinical research may do so. As the unit’s APN, I work with the interested clinicians to frame the clinical questions and determine the feasibility of doing a study. To that end, the questions all emerge from practice but may be formulated by any of the team members. Earlier in the program’s evolution, most of the project topics were proposed by me. However over time, the sophistication of the MICU clinicians has increased, and more of the research questions have come from them. The unit has acknowledged that the clinicians are more "science based," meaning that the clinicians openly question practice and "our way of doing things" and often ask about the scientific basis or the evidence base for clinical practices, routines, and procedures. Although this observation is anecdotal, it has been offered by numerous administrators, clinicians, and physicians who visit the unit, as well as by the MICU clinicians. The MICU’s scientific orientation is often described in comparison with that of other units in the institution and elsewhere as "different" and "exceptional." From my perspective, the evolution of clinicians who question practice and come to the MICU to "do clinical research" speaks to the sophistication of the clinicians. They do think that research is part of what they do. In fact, clinical research is not only considered part of what they do but is also a means of building their clinical and professional standing both within the unit and as a means of promotion via the institutional clinical ladder. All disciplines participate, and multiple projects may be ongoing at any time. Generally, 2 to 4 clinical projects are in progress at the same time.
HOW WE DO WHAT WE DO: THE PROCESS
Clinical research projects get started in a number of different ways. Beginning clinical researchers often prefer to be able to "sign up" to participate on a predetermined project of interest (eg, a multisite study on intrahospital transportation of critically ill patients) or to choose to participate on a research team whose project is to be determined by the team. Some approach me and ask to be included as a team member on the next study planned by me. More seasoned clinical researchers may seek out specific individuals to work with them on a project of interest. An additional popular option is to be a member of a team of researchers doing ongoing work in a specialized area such as weaning. In this case, the clinicians approach the clinician researchers with a request to be a participant in the ongoing research. I or a medical director, nutritionist, or clinical pharmacologist may head these projects. Occasionally, MICU clinicians participate in projects originating outside the MICU that require partnering, data collection, and coordination in the MICU as well. An example is a study on the use of restraints in the hospital, led by an expert clinician from another critical care unit.
For most projects, the clinicians meet with me, and the study is developed step by step. All elements of the study are discussed, and everything from the development of the human investigation proposal to the data collection instruments are developed in biweekly meetings in the unit. I select the project coordinator (generally someone who has shown "follow through" and perseverance on other projects and is willing to be the day-to-day clinical manager). The project coordinator coordinates the meetings of the team in addition to many aspects of staff in-service training on the project and data management.
Role of the APN
In descriptions of the MICU research program, my mentoring functions as the APN must be accurately portrayed. Clinicians who have never done clinical research are often overwhelmed by the process and think that the scope of the project is simply too large for bedside clinicians to tackle. It is extremely important that I, the research mentor, be willing to guide the clinicians through every step of the process. Even a literature review can be a daunting task for clinicians who may not have experience in doing one. Occasionally, I must sit with the clinician while he or she does the literature review. If the topic is one on which a lot has been written, then reviewing the existing articles for their merit is another essential step in the mentoring process. Writing (anything from the hypothesis to the human investigation proposal) always requires a lot of guidance, and rewriting is the norm. In an effort to keep the process moving, I must balance the rewrites with "just doing it" after a few iterations and getting the proposal submitted in a timely fashion. I often check with the clinicians at every step so that they receive any help they need. Given that the clinicians are bedside caregivers, a balance is struck between teaching of the various steps and moving the process forward. This point is the one at which many colleagues who wish to guide clinicians through the research process falter. I think that it is naive to assume that this level of help is not required. Although some would argue that the level of guidance described is excessive, the clinicians learn rapidly by being shown, and with each successive study, the clinicians become more independent and confident. Further, it is in keeping with the realities of a very busy clinical practice. For the clinicians to be excited and energized by the projects, as one clinician said, they must be "do-able." Finally, I must be generous with my time, nonthreatening, and optimistic. Enthusiasm for clinical research and a strong clinical background are prerequisites if the clinicians are to be inspired to want to participate.
PROJECT GUIDELINES
Some guidelines for the projects are used consistently. These guidelines are discussed with all project participants at the beginning of each of the projects.
1. The project must be one that the entire group considers clinically important.
Many good questions emerge in our discussions of "clinical projects to study." However, not all questions are of interest to team members. An example is a clinical question on the efficacy of instillation of isotonic sodium chloride solution before suctioning. After reviewing the literature on the topic, the majority of the research team decided that the study question was too broad. Further, they recognized that although numerous studies had already been done on the topic, many more complex questions remained to be answered. They thought that it would be necessary to do many consecutive studies and that doing all those studies was not feasible in the time frame within which they hoped to work. They preferred a study that would move more quickly and answer a more pressing clinical question, such as that related to the timing of inner cannula changes for tracheostomy tubes. Sometimes the rejected topics are shelved and offered as potential projects later. Some topics have been reconsidered and selected eventually; others have not.
2. The project must be feasible.
Feasibility for clinical studies is essential to success. For clinical projects, the definition refers to the ability to get the project accomplished in a fairly short time (we always double the time we think is reasonable). Generally, this restriction means that a pilot project must be completed in 3 to 6 months. Although this guideline is not ironclad, it does help keep interest in the project high and helps keep all participants involved. Projects that require funding are not excluded; however, the ability to acquire money for the projects is considered in the determination of feasibility. Small amounts of money ($100–$500) are rarely a problem and can be acquired with small grants and funds set aside to use for this purpose (eg, institutional quality assurance grants). Larger sums are more difficult to attain but again can be sought via professional organizations that regularly award such grants for small projects (eg, American Association of Critical-Care Nurses). Projects that are qualitative in design are difficult to do and generally require more concentrated time spent interviewing patients and or making observations. Generally, these projects, although tremendously important, and of interest to the clinicians, are neither practical nor reasonable from a time perspective. These projects are routinely discussed, but to date none have been selected for study by the groups.
All projects take time, and sometimes data collection is difficult. The project coordinator is responsible for making sure that shifts are covered and/or that someone is "on call" to collect the data. However, most data are collected during a normal workday. Coverage while "on shift" is rarely a problem, because all clinicians in the MICU understand the importance of the data collection and are generous in agreeing to "cover" so that the data can be collected in a timely fashion.
Last, serious consideration of studies that require informed consent is important. Although every study is submitted to the human investigations committee for review, studies that require informed consent are considered less attractive. Because the nurses often work a wide variety of shifts, ensuring the availability of a clinician to obtain consent from a patient’s family if the patient cannot provide consent is difficult. Although a number of our studies have required consent, such studies do take longer to accomplish, and thus we consider this factor when we design studies for the unit’s clinicians. Most of our studies to date have been noninterventional and have received exempt status (consent not required) from the institutional review board.
3. The clinician researchers are responsible for "closing the loop," that is, applying findings to practice.
The extent of closing the loop and/or applying the research to practice varies with each project. Often, the dissemination of results starts with a summary of the findings at a "practice committee meeting." Or, the clinicians may develop a "mailbox in-service," a 2- to 3-page summary of the project, results, and implications for practice that is placed in the mailbox of each member of the unit’s staff and distributed in other ICUs as appropriate. Presentations on the research are also given at different formal and informal meetings within the institution (eg, nursing leadership meetings, grand rounds, unit in-service training sessions, and staff meetings). The clinicians enjoy this role and often "take turns" as the opportunities arise.
4. Once the team completes the project, all members participate in the development of presentations and manuscripts related to the project.
We do follow a few unit traditions and guidelines. One example is that the first project will be submitted as a poster presentation (or talk) by the team and presented by the project coordinator at a national meeting. This arrangement is important to the clinicians because the administrator of the unit has agreed to pay expenses for the presenter of any project presented nationally. This "guideline" is an acknowledgment of the effort and dedication shown by the project coordinator. Subsequently, the rest of the team members can apply to be presenters at other meetings of their choice, and if accepted, they too are given financial support to attend the meeting. My major role as the APN is to help select the meetings and teach the clinicians how to prepare an abstract for submission. If the proposal is accepted, I mentor the clinicians in the preparation of either the poster or the presentation. The work is also always presented by the team at our local annual "Changing Practice Through Clinical Research" conference. This conference is attended by a multidisciplinary audience and is a popular venue for the presentation of ongoing and completed projects.
Decisions about manuscripts and the submission of manuscripts to various peer-reviewed journals are made by the group with guidance from me. However, the relative writing contributions of the clinicians weigh heavily in the decision about authorship and who will be the lead author. Sometimes authorship is the decision of the person who develops the project and writes most of the manuscript. Essentially this person is the one who does the most work and takes the most responsibility overall for the project. It may not be the person who suggested the clinical question, because all participants help articulate potential study topics and the selection of a topic is ultimately a team decision. In addition, participants acknowledge that although the question is important, the skills of the person who developed the question may not be adequate to develop and complete the project.
All members on the teams consider themselves learners. Thus, commonly the 2 first authors of an article are the study coordinator and the primary investigator. I am often the primary investigator, but increasingly, the primary investigator is an MICU clinician who has become an experienced MICU clinical researcher and has developed skills in leading a team (as a project coordinator). Some of these persons are also beginning to write for publication. I act as the chief editor of the manuscript and teach the clinicians by having them edit and read the edit of others.
OUTCOMES OF THE RESEARCH PROGRAM
Recruitment and Retention
The MICU’s reputation both within and outside the institution has been one of innovation and creativity, in part because of the research program. Clinicians who interview with the manager of the unit are informed of the program and its popularity. These clinicians often tell us that they selected the MICU in order to participate in clinical research. This finding is especially true with "new" nurses, who say that they think that few units, other than the MICU, encourage less-seasoned clinicians to participate in research. The career goals of many of these nurses differ greatly from the goals of nurses from previous generations; the former group sees participation in clinical research as a necessary career opportunity. Although the recent nursing shortage has hurt our staffing, as it has others nationally, we have nurses who have stayed in part because the MICU has a research program. For some of the more "seasoned" clinicians in the unit, the research program has given them a new, interesting, challenging direction to take professionally, without having to leave the unit to be a "research nurse."
Multiple Presentations and Publications
The clinicians have participated in more than 100 clinical projects, presentations, and/or publications. A brief description of a selected list of MICU projects (many referred to in the interviews by the clinicians) is included in Table 2. These presentations and publications are a source of pride for the clinicians, the unit, and the institution.
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Real Changes in Quality Care and Cost Savings for the Unit and the Institution
A number of projects have resulted in financial gains for the institution. The larger scale projects such as the outcomes-management approach to the care of patients receiving long-term mechanical ventilation have resulted in millions of dollars in cost savings.18 In other smaller projects, such as a study on how to secure nasogastric tubes, the savings were in the thousands of dollars.19 Many more projects have resulted in practice changes that cannot easily be translated into cost savings but clearly may improve the care of the patients. Examples include a study that helped determine the optimal position for weaning patients with large abdomens21 and another study that helped determine ways to prevent the inadvertent placement of gastric tubes into the lungs.16
Promotional Opportunities
At our institution, nurses advance by means of a clinical ladder that acknowledges behaviors in many different practice domains. One domain is that of research. Participation in the MICU clinical research program is seen as a way not only to learn about clinical research but also to give a professional presentation and publish (both of which are rewarded). These practice behaviors are attractive to those seeking advancement to an "advanced practice" level on the ladder (clinician 4 or 5) and also to those advancing to the clinician 3 level, because one of the behaviors at that level is involvement in unit clinical research.
Institutional Recognition
The institution has recognized the contributions of the MICU and has used the MICU as an example during site inspections such as those of the Joint Commission on Accreditation of Health-care Organizations to indicate the emphasis the clinicians have placed on evidence-based practice. The administrators recognize the importance of the program and support it by graciously financially supporting the participants who present the projects at regional and national meetings.
CONCLUSION AND SUMMARY
Clinical research remains a desired goal of the profession. Unfortunately, the methods we have traditionally used to spark the interest and commitment of clinicians have not been universally accepted or successful in attaining our goal. Although nothing is inherently wrong with journal club meetings, research forums, and partnering with academicians, these methods of inspiring research rarely do so. Partially, that failure is because a leader, perhaps a cheerleader, is needed, someone who is willing to teach, support, coach, and call to task the clinicians who wish to "do" clinical research. As noted by Hanneman,26 the presence of a unit-based expert is necessary for the "catalytic conversion" of others: "Expert nurses methodically build non-expert nurse expertise through flexible, context dependent strategies." The mentor must understand the abilities, the background, and the time commitments of the clinicians so that the support is appropriate for the task. For example, an academician friend who wished to do some research "partnering" with some clinicians in a practice area of interest thought that the main role of the clinicians would be as data collectors. In this collision of philosophies and understanding, the clinicians, who wanted the academician to "show them" how to do the research and teach them at each step, were angered by the academician’s perspective of their potential to contribute to the research process. The project was not successful because neither the clinicians nor the academician understood the perspective or expectations of the other. For clinical research to thrive and prosper, indeed to become part of what we do in practice, we must learn from the clinicians who can tell us what works and what does not. The comments of the clinicians recorded in Table 1
are filled with advice, should we choose to listen.
Clinical research is part of what our MICU does. The clinicians are proud of their accomplishments, and some are now mentoring others in the process. The success of the program can easily be duplicated in other settings. I hope that we begin to acknowledge the power of teaching research as part of clinical practice and start to reward and acknowledge our clinicians for their involvement.
References
This article has been cited by other articles:
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  M. Hodge, L. D. Kochie, L. Larsen, and M. Santiago Clinician-Implemented Research Utilization in Critical Care Am. J. Crit. Care., July 1, 2003; 12(4): 361 - 366. [Abstract] [Full Text] [PDF]
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