Bridging the Clinical-Research Gap Through Nursing Collaboration

Nancy J. Jaretz and Sarah K. Rosenbloom

The process of conducting research protocols on clinical psychiatric units pre- sents many challenges for research and clinical staff alike, challenges that are especially daunting when the clinical psychiatric unit is not designed for or ded- icated to research. Thii article describes an attempt to bridge the gap between clinical and research needs through nursing collaboration, focusing on the spe- cific issue of managing treatment-resistant psychotic patients in a neuroleptic- free state before trial on clozapine. It suggests that applying research methods to the process of research itself is as necessary as applying them to the specific protocols conducted within it. Copyright 0 1994 by W.B. Saunders Company

R ESEARCH, to be valid and generalizable, de- mands precision in all aspects-design, im-

plementation, data collection, documentation, and data analysis. Clinical research, by definition, oc- curs in a nonlaboratory setting where variables are more difficult to control (Kane, 1991). Studies conducted in the psychiatric milieu must be flexi- ble to accommodate to the lability of the individual and variations of the unit and yet manage to con- clude with quantifiable results. Additionally, the clinical and research foci may be seen as incon- gruous or conflicting in ideology (Hansen, Lowe, Wilson, Keck, Keepers, & Munetz, 1993). For example, the philosophy directing patient care may emphasize such things as individualism and self- determination, whereas the research perspective emphasizes commonalities, generalizations, and control (Munhall, 1992; Passamani, 1991). How- ever, for clinical research efforts to be successful, the research and clinical teams must share respon- sibilities, clarifying their respective roles in the process. Study design and data analysis are often largely the purview of the research group, whereas

From the Commonwealth Research Center at Massa- chusetts Mental Health Center and Harvard Medical School, Department of Psychiatry, Boston, MA.

Address reprint requests to Nancy J. Jaretz, RN, BSN, MEa Massachusetts Mental Health Center, 74 Fenwood Road Boston, MA 02115.

Copyright 0 1994 by W.B. Saunders Company 0883-9417/94/0805-0002$3.00l0

conditions for implementation, data collection, and documentation are shared by the clinical staff.

Nursing staff use the nursing process (Yura & Walsh, 1983) to establish rules for orderly prob- lem-solving and practice. To conduct research, the process must be implemented with an additional focus on precision and measurement. The steps of the process are applied beyond routine clinical practice in the following ways: assessments define critical baselines; nursing diagnoses must include adaptation to a research context; plans acknowl- edge protocol requirements; procedures of imple- mentation help maintain study integrity; and eval- uations provide feedback for research decisions as well as clinical actions. Conversely, incorporating research into practice can strengthen each step, fo- cusing the collection of information, validating di- agnoses, promoting effective interventions, and documenting success or failure of outcomes.

TheoreticallConceptual Framework

Amdt and Huckabay (1975), in their systems approach to administration, discuss the conceptual and physical acts that are necessary to effect change. They suggest that conceptual acts (ideas, philosophies, decisions) and physical acts (com- munication, teaching, self-actualization, imple- mentation) are needed to create a conceptual and physical environment that can achieve organiza- tional and institutional objectives. The accommo-

298 Archives of Psychiatric Nursing, Vol. VIII, No. 5 (October), 1994: pp. 298-302

BRIDGING THE CLINICAL-RESEARCH GAP 299

dation of research needs, while at the same time attending to clinical needs, is a change that re- quires such conceptual and physical acts. Although researchers may be involved in clinical care of in- dividual patients, their collaboration with clinical staff regarding procedures and evaluations may be incomplete. For example, clinical staff may be re- luctant to refer patients as potential subjects for the research protocols. The research team may fail to hear concerns expressed by the staff regarding safety, workload, and coordination of care.

Based on Stevens’ (1985) concepts of continuity and change, it may be considered that research, representing a change, can be viewed as an oppor- tunity (i.e., fresh look at patients, potential for improved prognosis, professional growth) or as a threat to stability. It is possible for clinical staff to perceive their goals as being in common or con- flicting with those of research (i.e., increased fre- quency of vital sign assessment could be viewed as an opportunity for assessment or as an increase in monitoring demands). Likewise, the expression of goals might occur through a common or different language, thus enhancing or impeding communi- cation. Further, there might exist a collaborative or competitive sense between clinicians and research- ers depending on priorities, interests, and institu- tional role of each group. It is conceivable that a positive view of change, shared goals, and a col- laborative sense can translate to physical acts that could facilitate and enhance research pursuits.

The Problem and its Context

The Massachusetts Mental Health Center (MMHC) is a state facility that serves a catchment area of more than 300,000 people in the Boston area. Its locked intensive care unit, chronic care unit, and day hospital have provided care for some 700 poor, uninsured patients admitted annually. These units, as well as MMHC’s continuing care service, outpatient department, and quarterway house, are committed to the care of the seriously mentally ill, primarily those with diagnoses of schizophrenia, bipolar disorder, major depression, and substance abuse. The severity of their illnesses and their limited resources make these patients ideal participants in psychopharmacological re- search studies. These seriously ill patients present an opportunity to test medications with those who have the least to lose and the most to gain; many have been ill for 10, 20, or even 30 years. They

would not otherwise have access to newer, and often more expensive, drug treatments. However, the illness and deprivation that make these patients interesting and accessible also make them a chal- lenging group with whom to work, inasmuch as they are often dangerous to themselves and others and have often assumed the role of invalid. The clinical staff is constantly working to contain ex- pressions of illness such as inappropriate and ex- treme behavior while maintaining individual safety for patients and staff. Their considerable efforts are conducted with minimal physical resources, meager support services, and in frequently over- crowded conditions. A unit with a capacity of 45 patients has, at times, reached a census of more than 70 patients. Thus, attending to the complex- ities of research protocols presents an additional and unwelcome burden. As one unit nurse put it, “It’s hard to be poppin’ people up and down for postural vital signs when patients are being re- strained and you don’t have enough towels or toilet paper.”

Because of its academic affiliation with Harvard University, MMHC has had a strong research tra- dition. The commitment to research was renewed in the late 1980s coinciding with the advent of new atypical neuroleptics. Clozapine, one of these drugs, gave new impetus to the conduct of clinical trials at MMHC. Initially, the process took place on a case-by-case basis through research-treater collaboration. However, it soon became apparent that a more formalized system was needed if qual- ity and continuity of care were to be protected and the integrity of research protocols was to be main- tained .

The growing emphasis on research also high- lighted differing perceptions of the clinical unit’s purpose and priorities. As more patients partici- pated in research protocols, the need to balance group and individual needs crystallized. The re- search team, seen as responsible for the change in emphasis, assumed the associated responsibility of defining impediments and enhancements to clini- cal research implementation.

In the summer of 1993, the mission of the locked psychiatric intensive care unit was offi- cially changed to that of a research and evaluation unit. The 45-bed capacity was reduced to 16 beds, structural (physical) changes were planned and ser- vices were offered to patients throughout the com- monwealth. As the unit matures it becomes clear

300 JARETZ AND ROSENBLOOM

that the changes in philosophy and practice did not begin with the official change of purpose; the seeds were sown during the preceding years, with nurs- ing collaboration playing a vital role.

Problem DefnitionlQuantification

With responsibility for 24-hour monitoring of patients and implementation of specific aspects of protocols, the nursing staff was strongly affected by and valuable to research efforts. In 199 1, they had been asked to complete a questionnaire (Table 1) designed to elicit their general perceptions of research, and specific impressions of the changes involved, compatibility with clinical goals and col- laboration. Despite personal contact by both the research nurse and nurse clinician, the return rate was very low (23%). The low rate of return sug- gested the lower priority of responding to the ques- tionnaire in relation to competing demands. This may also suggest that questionnaires received were returned by individuals who had strong feelings regarding the subject or were more compliant. De- spite the small return, which did not allow statis- tical analysis, we believe the data suggest a trend of attitudes among the nursing staff. They also defined an important related research question re- garding a specific research practice.

Items that elicited opinions about research in general (items 1, 2, 3, 5, and 6) were positive overall as were those regarding change (items 7, 8, 12, and 13). There was less agreement in the com- monality of goals (items 4, 9, 10, and 11) and a sense of collaboration (items 14, 15, 16, and 17) (Table 1). Although research staff used clinical assessments and explained protocols, they did not give feedback to the clinical staff on patient re- search assessments. Although the majority of re- spondents felt patients were adequately monitored, a majority also felt that research needs interfered with “getting the work done.”

The most intriguing responses were in relation to the drug-free periods (a washout and neurolep- tic-free period antecedent to the pharmacological protocols). Although the majority believed the drug-free period to be a necessary process to pre- vent drug interactions and even a desirable process to allow a new (nondrug affected) view of the pa- tient, all respondents saw the practice as a potential threat to patient and milieu safety. This strong dis- parity between the conceptual and actual practice

warranted further investigation. Additionally, a lit- erature review showed little attention to the man- agement of patients in a neuroleptic-free state. Puskar, et al. (1990) discuss nursing management of acutely psychotic patients without the use of psychotropic medications on a schizophrenia re- search unit. This work, although providing excel- lent suggestions for intervention, did not assist us in quantifying the problem.

Several members of the research team investi- gated the specific response to withdrawal of med- ications. Although encouraged that many positive perceptions of research existed, it was believed that examination of a particularly contentious area could further facilitate clinical-research collabora- tion. Perhaps it would be possible to align concep- tual and physical acts in this area so that change could occur.

The Study

A retrospective assessment was conducted of clinical records on all patients who had undergone a drug washout period while enrolled in the open- label study of clozapine at MMHC (Kalinowski, Jaretz, Rosenbloom, Yin, & Green, unpublished manuscript). The aims of the study were to eval- uate the effect of medication washout in a group of patients with treatment-resistant schizophrenia and determine the presence, type, and timing of in- creased symptoms and/or disruptiveness.

The best predictor of the level and manner in which patients become disruptive during washout was their style of disruptiveness while taking med- ications (similar symptoms dominated the clinical picture during washout for 70% of the subjects). The median amount of time that elapsed until a worsening of symptoms in those who did have in- creased disruptiveness was 1 week (range = 0 to 40 days).

The study results implied that chronically psy- chotic, treatment-resistant patients could be main- tained safely on an inpatient unit with benzodiaz- apines but without neuroleptics and/or mood stabilizing medications for drug washout periods of up to 1 month. They further suggested that the best predictor of symptoms during medication with- drawal was the character of the patient’s behavior before such withdrawal. This finding allowed us to develop a proactive approach to the drug-free pe- riod.

BRIDGING THE CLINICAL-RESEARCH GAP 301

Table 1. Questionnaire Results

Responses

Strongly Strongly Agree Agree Disagree Disagree

1. Research benefits the individual patient.

2. Research benefits the population as a whole.

3. Research can positively affect the overall standard of care.

4. Research needs interfere with getting the work done.

5. Results obtained from research make time invested worthwhile.

6. Research offers an opportunity for professional growth.

7. Patients on research protocols receive an especially detailed

medical work-up.

8. Drug-free periods allow staff a new view of the patient.

9. Drug-free periods potentially threaten patient and milieu safety.

10. Drug-free periods assure safety by preventing drug interactions.

11. Patients on protocols are adequately monitored by research staff.

12. Protocols increase assessment demands on staff.

13. Protocols facilitate closer observation of patients.

14. Clinical staff have an opportunity to communicate research

patients’ milieu progress.

15. Research staff share information on protocols.

16. Research staff offer results of patient assessments.

17. Clinical and research staff work well together.

18. The most positive aspect of supporting research is:

New hope for hospitalized patients (3)

Improved patient care (3)

Benefitting population as a whole (2)

Improved nursing practice (2)

Benefitting individuals (1)

Improved medicine 11)

New learning (1)

19. The most difficult aspect of supporting research is:

Not feeling involved in or informed about research (3)

Amount of time necessary for monitoring patients 12)

Trying to fit all the work in the day (2)

Large numbers of research patients 11)

Gaining research patients’ cooperation (1)

Drug-free period safety risks (1)

20. Suggestions from nurses:

Research staff to do monitoring (2)

Clearly relating goals of the research (2)

Keeping a low ratio of reseach patients to unit population (11

Have reseach doctors more accessible (1)

Assistance in containing patients during drug-free periods (1)

Assistance in setting reseach priorities (1)

Improving communication by reinforcing benefits to the patient (1)

Having the opportunity to present cases for discussion (1)

Computerizing data for access (1)

2

3

6 1

1

2

2

2

4

2

N=9

Incorporating Research Into Practice

The retrospective study allowed a clearer view of what specific management issues needed to be addressed in relation to the drug-free period. Fur- ther, it showed the willingness of the research team

to examine its own activities and empathize with the clinicians’ position. It did not immediately translate into a change in practice, however. The gap between research and practice is well- documented (Polit & Hungler, 1993). Effecting change is a gradual and continuous process.

JARETZ AND ROSENBLOOM

Using Amdt and Huckabay’s (1975) model, ef- forts were first directed at conceptual acts. The results were shared using Polit and Hungler’s (1993) suggestion to “disseminate aggressively, communicate clearly, and suggest clinical implica- tions” (p. 416). A poster presentation was given on Research Day, a discussion was held with unit staff and copies of preliminary results were given to nursing administration. Because the data were collected from the staff’s own records, its credi- bility was enhanced. Further, the available litera- ture on nursing management was shared with nurs- ing staff, who then proposed ways they could integrate this information into planning their care. The creation of a conceptual environment had be- gun.

To sustain contact between the research team and nursing staff, the research nurse and nurse manager of the acute clinical unit set up weekly 15minute education and discussion sessions. The research team shared information on psychophar- macology protocols and assessment instruments emphasizing their clinical relevance. Their nursing concerns, questions, and priorities were elicited.

Time for collaborative education and planning time increased to several hours per week as the unit mission officially was to become that of research and evaluation. Nurses on the clinical unit joined the research team in making structural changes to the unit and in developing new documentation forms to record more precise baseline and progress data. They reviewed the nursing process in light of broader needs; a physical environment began to emerge that could facilitate both clinical and re- search efforts. As the clinical staff became more knowledgeable about the ideas, philosophy, and decisions of the research process, they were more prepared to not only adapt to, but also to facilitate, the changing organizational objectives.

Bringing together the efforts of clinical and re- search staff is a complex and lengthy process. It was our intention to look broadly at the issues of collaboration, common goals, and change and their antitheses. This led to a focus on a specific,

particularly challenging issue, i.e., the manage- ment of patients in a drug-free state. The process of quantifying, analyzing, and communicating in- formation on this subject suggested strategies to integrate other clinical processes with research. The ultimate lesson was in learning to bridge the gap between clinical and research needs by apply- ing a research approach to the process of research itself.

ACKNOWLEDGMENTS

The authors would like to acknowledge the contribu-

tions of Alan I. Green, MD, the staff of the Common-

wealth Research Center and Evaluation Unit at the Mas-

sachusetts Mental Health Center, and Gerald Howell, RN.

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