Nurses and physicians must interact for valid clinical research

Research in Nursing & Health, 1987, 10, 149- 154

Nurses and Physicians Must Interact for Valid Clinical Research

Karin T. Kirchhoff

The results of clinical research provide information for improving patient care. Seldom can one profession conduct research in the clinical setting without communicating with other professionals affected by the research protocol. When informed consent is obtained from the patient, an investigator may think that sufficient communication to al l parties affected by a study has occurred. To conceptualize interactions observed between two professions, (i.e., nursing and medicine), five patterns are proposed: blocking research, hidden research, dumping research, negotiated research, and collaborative research.

The patterns are associated with various amounts or types of communication about research. Each description of a pattern contains (a) an example of the interactions possible in that model, (b) a set of assumptions that underlie those interactions, and (c) a number of potential outcomes. The interactions described are real occurrences with some details changed to prevent identification of individuals or institutions. These examples of research interactions occurred at several institutions. The outcomes listed are not all possible at the same time, but are a compilation of o number of outcomes that could occur.

Understanding the various patterns of interaction can provide information so that the outcomes can be altered. With appropriate communication interactions that begin in a less desirable manner can be altered to attain a more positive outcome. Thus, knowledge of the various patterns can lead to conscious decisions about interactions.

BLOCKING RESEARCH

Case No. I Two nurse faculty members attempt to

conduct a study of patients. The chief of staff decides that the investigators need to contact each attending and/or resident before enlist- ing one of “their” patients in a nursing study on quality of sleep. The patient would have been requested to complete a questionnaire on perception of sleep and factors affecting sleep, requiring about 15 minutes of time. Contacting each physician required an inor-

dinate amount of time on the investigator’s part, but the contacts were made.

Case No. 2

A nurse, a doctorally prepared faculty member, wished to study the effectiveness of a treatment in decreasing anorexia in patients undergoing radiation and chemother- apy. After having the study reviewed and approved by the institutional review board, the nurse-researcher met with the research director for the nursing department in the hospital. As a courtesy, the nurse-researcher sent a copy of the proposal to the section chief. This chief physician wrote a letter to the investigator expressing concern because the research was approved without the consent of the responsible physician. He wanted to clear through his section those studies that related to patients. He withheld approval of the project. This section chief also told the

Dr. Karin T. Kirchhoff is Associate Director of NursingIResearch at The University of Utah Hospital

This commentary was received May 17, 1985, wos revised, and on December 5, 1986, wos

Requests for reprints may be oddressed to Karin T. Kirchhoff, Ph.D., Associate Professor, College of

and Associate Professor, College of Nursing, The University of Utah, Salt Lake City.

accepted for publication.

Nursing, The University of Utah, 25 South Medical Drive, Salt Lake City, UT 841 12.

0 1987 Wiley 0160-6891/87/030149-06 $04.00 149

150 RESEARCH IN NURSING AND HEALTH

institutional review board that physician approval was necessary before they could approve a study. The board responded that where research does not involve specialized medical knowledge or medical risks, and adults are fully able to give consent, informing the physician is a courtesy. The board did not believe that checking with the physician in this case was necessary. Also, in the physician’s letter to the nurse-investigator, he wanted the nurse to contact a physician who was an expert in anorexia. He thought there could be a possibility of collaborative research under his direction.

In these cases a patient who has made decisions and functioned independently before admission becomes the “property” of the physician upon admission to the hospital. The patient loses the ability to think and make decisions. Other professionals need to seek the permission of the physician to contact the patient (Davis, 1981; Noble, 1980).

Another view could be that ownership was not really the issue. Perhaps all the physician required of the researcher was to be informed (at times) unless the study could ad- versely affect ongoing or planned medical in- terventions. By informing the physician, the impact of a nursing study on medical care can be evaluated.

A nurse who encounters this type of interaction can feel powerless. If there is no support, the temptation can be to give up or lash back. The nurse also can meekly submit and smolder while biding time. There will be lack of cooperation in the future if the same physician or group of individuals attempt a study where the nurses’ cooperation is needed, (e.g., the nursing staff could undermine data collection).

A preferable outcome is that after the study is completed, in spite of delay or de- crease in subject accrual, a summary is sent to the physician. The physician might see that the study progressed without incident and be more facilitating the next time. A more assertive, early intervention is needed such as requesting a meeting with the ob- structing physician, giving him information to dissipate his need for control.

HIDDEN RESEARCH

Case No. 1

The nurse on 3-11 is caring for a patient and notices a strange medication order with a

series of additional orders for sequences of vital signs. She wonders if a study is being conducted on this patient, but there is no informed consent on the chart. No one is avail- able to ask.

Case No. 2

The head nurse noticed that patients re- turning from simple surgical procedures were not ambulating for several days postop- eratively. She also noticed a difference in the anesthesia recorded. She wondered if anesthesiology was conducting a study and, if so, were approvals and consents obtained. She communicated her observations to nursing administration, but nothing happened.

Physician research on the patient can be relabelled as clinical practice or clinical evaluation. These studies do not require institutional review or patient consents. A fine line exists between research requiring approval and evaluation combined with practice.

Physician experiments can be thought to affect only the patient, and other health care providers do not need to be informed. When other health professionals are not informed they feel they do not have any meaningful contribution to make to the data. However, they may be observing the patient more frequently and/or for a longer duration than the study’s protocol has recommended, and could have a significant impact on the findings of the study.

Concern arises on the part of the nursing staff caring for these patients. The nurses try to understand what has happened but do not know who to notify. The institutional review board will probably receive phone calls or letters requesting information about whether approvals have been obtained. Another possibility is a detached attitude will develop about the study because of lack of information. Little attention is paid to the “unneces- sary orders.” When patients are sleeping and the patient does not seem to need additional vital sign readings, the data may not be gath- ered.

A more positive outcome could result if the head nurse contacts a supervisor, and they meet with members of anesthesiology. The matter is clarified. Anesthesiology agrees to meet with the nursing staff before initiating future research. Alternatively the head nurse attempts to meet with anesthesiology, but they refuse. The head nurse de-

NURSES AND PHYSICIANS MUST INTERACT / KIRCHHOFF 151

cides to monitor the effects of this new anes- thetic listed on the record.

DUMPING RESEARCH

Case No. 1

A physician “drops” a protocol on a head nurse the day before a large study is to begin on a nursing unit. The study requires nursing time and effort and the head nurse is con- cerned.

Case No. 2

A letter is sent to a unit telling staff to contact a certain physician if a patient is ad- mitted with a particular diagnosis. The patients are needed for a study the physician is conducting. (There are examples of this problem in nursing as well, but the focus of this paper is on interaction between nurses and physicians).

In these examples, nurses feel that physicians think nurses only follow physician orders, so these research protocols are just more medical orders to be completed. The physician may think the request is usual and ordinary and does not require additional activity on the part of the physician. A one-day notice is thought to be sufficient for the head nurse to read, digest, and communicate to staff what is required for this study. Medical orders do not require more notification, so the physician wonders why should research? Since nurses are responsible for carrying out physician orders, they will prioritize their duties to accomplish the research over other activities they feel are less important. How- ever, nurses have research of their own that they would be interested in conducting. They feel that to participate in someone else’s research without notification and discussion on the project does not take their own research responsibilities into account.

With short notice, the study usually does not begin as scheduled. The physician may be disappointed, angry, frustrated, or all three. Appropriate planning, with time frames, can alleviate the problem. Addition- ally, the head nurse and staff may feel guilty about their inability to comply with this request.

When the study begins, the quality of the data may be poor if the nursing staff remem- bers how the study was introduced. Staff

may be angry about being “dumped on,” and the next study may receive decreased cooperation without justification.

When direct communication is used, the head nurse informs the physician that the staff cannot do the request on one-day’s notice. They negotiate a new start date, and the staff receives appropriate lead time and information as needed.

NEGOTIATED RESEARCH

Case No. 1

The physician makes an appointment with the head nurse to discuss an upcoming study, and sends materials ahead of time. The nurse has prepared for the meeting by reading the protocol and the research proposal ahead of time. The nurse points out that the schedule for data collection of specimens is too inten- sive for the night staff and the timing of specimens would be more likely to be accom- plished if it coincided with the usual blood drawing time. Discussion ensues and a give- and-take yields a workable arrangement. Au- thorship or footnote acknowledgements are negotiated as appropriate.

Nurses see their major responsibility as patient care, which supersedes favors to help others, even if the purpose is science. With planned discussion of the study, the nurse can provide valuable input that will facilitate the conduct of the study. If the nurse becomes a substantial contributor to the study, credit for that involvement should be received. The intimate involvement evidenced by participation in planning and authorship provide for greater commitment to the study on the part of the nursing staff, and then assisting the study is not perceived as a “favor.”

Whether a nurse is a participant in a study or not, nursing has rights to information that would affect patient care. Although participation cannot be taken for granted, most nurses are interested in being involved in research and see the value for patient care.

The outcome of negotiating favorable con- ditions for all parties involved are many: (a) more willing participation will occur, (b) a greater commitment can be made to the study since concessions were made to facilitate cooperation, (c) also, a sense of ownership for the study is engendered because of the communication process, and (d) a higher quality of data will be achieved.


COLLABORATIVE RESEARCH

Case No. 1

The physician wants to collect data on the relationship of oxytocin challenge tests to subsequent fetal outcomes. The physician discusses the research idea with the outpatient nurse. The nurse volunteers to assist, since she has the originals of the printouts. The nurse reviews the printouts, and the physician gets the data on fetal outcomes. An abstract of the results is accepted, and the nurse goes with the physicians to their national meeting.

Case No. 2 A clinic nurse is conducting research

about the use of breast massage to obtain the oxytocin challenge test criterion (three uter- ine contractions in 10 minutes). The medical department head, knowing the nurse’s research interests, visits the clinic to deliver a related article from the latest issue of Obstet- rics and Gynecology.

Case No. 3

A critical-care nurse talks to the medical director of the unit about a study on the difference in mean arterial pressures in different positions. The nurse had noticed that the pressures changed as the shifts of nurses changed. The medical director suggests that maybe the nurse should also take into account the level of the transducer. The nurse accepts this input and builds patient position and transducer level into the study.

The study is conducted by the nursing staff with physician support. The study wins a national research award at the annual meeting of the critical-care nurses and is accepted for publication in a nursing research journal. The physician gets a footnote credit.

Case No. 4

Nurses from five oncology outpatient set- tings are interested in pain medication sched- ules. They gain support from their physicians to schedule patient analgesics as the random assignment dictated with the physicians us- ing their choice of drug.

In these cases it can be seen that several professions can contribute to clinical research whether the principal investigator is

conducting a study about a nursing concern or a medical concern. The joint efforts among health professionals have the greatest potential to effect improvements in patient care.

The mutual benefit from these interactions in research leads to future responses that are positive. The different vantage points of these professions yield more significant clinical studies and, therefore, more fruitful information. All these studies were assisted by input from more than one group of professionals.

The previous discussion was based on iso- lated instances across several institutions and at different time periods. In the next part of the article a descriptive survey at a large university medical center is described. The purpose of the survey was to assess the type and amount of research involvement by the nursing staff in medical projects. A series of complaints and questions from head nurses suggested the involvement was larger than was known by nursing administration.

Head nurses were requested to give information about experimental procedures occurring in their units at that time, and the tasks nurses were asked to do because of these studies. Questionnaires were distrib- uted at a head nurse meeting, and telephone and mail followup were used to obtain a 100% response rate.

The responses showed about one-half of nursing units were involved in ongoing studies. Some of the studies were on more than one unit, and most involved units that had more than one study in progress.

In assessing the involvement, each study was counted only once, despite the number of units listing that study. Three of the 50 studies reported had staff hired specifically to collect the data, or the investigator collected the data. Of the remaining 47 studies, requiring various amounts of nursing time, only four were approved by the nursing ser- vice research committee for that level of involvement.

The remaining 43 studies were categorized by type of nursing involvement: (a) notification of investigator, (b) administration of experimental drugs, (c) primarily data collection, or (d) miscellaneous. The latter category was comprised of tasks such as handling equipment, completing forms, or nursing care of a study patient.

The nursing involvement in these studies

NURSES AND PHYSICIANS MUST INTERACT / KIRCHHOFF 153

probably was underreported. Some involvement occurs with “hidden” research and would not be listed since the involvement was not known to the nursing staff.

For the first category of involvement there was one study reported in which the investigator requested notification of the presence of potential subjects. In this reported case, the head nurse remembered the contact took place during a busy time. This category was probably underreported because of the minimal effort required.

The second category of studies was the administration of experimental drugs (n = 13). The nursing involvement in these studies ap- peared minimal. However, in one case, experimental eye drops were to be administered before and after eye surgery at frequent intervals. The head nurse reported the staff nurse assigned to the patient was not able to do much else during the most frequent inter- val schedule of postoperative administration. The process of handwashing, dressing re- moval, administration of eye drops, and re- application of dressing required most of the time between the intervals of the administration of the eye drops. Staffing requirements for that unit were substantially increased because of just one study.

Most of the time involvement in experimental drug studies consists of the administration of the experimental drug instead of a usually ordered drug. In those instances, no additional nursing time was required. How- ever, other studies require additional chart- ing or monitoring of patients be done because an investigational drug had been administered. Information about the studies should have been provided to the nursing staff so they could monitor side effects, patient response, etc. This information was inconsis- tently present.

The involvement of nursing staff in data collection activities for medical studies ( n = 21) was the most frequently occurring category. The usual activity required was blood drawing or the collection of specimens such as urine, placenta, and cord blood. Some- times these data would have been collected in the normal eourse of patient care. At other times, the activity may have occurred but not at the frequency or time periods required fur the study.

The category labelled miscellaneous (n = 12) included activities ef recordkeeping, followup on patients, instructing patients about

tests, applying equipment, setting up for procedures, etc. One study required nursing as- sistance for 1-2 hours for each subject.

The outcome from these findings was the establishment of policies to assist nurses in cooperating with medical research without compromising normal nursing care. To obtain nursing cooperation it was required that the research had received institutional review board approval and had been consented to by the patient.

A policy was developed according to the categories of involvement found in the survey. Notification of investigators about the presence of patients meeting certain requirements was considered to be a professional courtesy and required no nursing department approval. When investigational drugs were to be administered, no approval was necessary except that which the research required institutional review board approval and patient consent, and that required for the professional administration of a medication. For the latter purpose, the pharmacy supplied drug data sheets to the nursing units when experimental drugs were administered. This sheet does not reveal which drug is administered, where more than one drug is involved. It tells the action of all the study drugs and known side effects, so that should a patient begin demonstrating a side effect, the nurse would know whether it was from the study or from the usual drugs. Then appropriate actions could be taken, and the nurse would be able to use the same professional knowledge to administer drug X, as other drugs.

For the category of data collection and miscellaneous, the policy was defined as requiring the head nurse to judge whether activities of the study were additional to usual care, and therefore required extra nursing time. Postoperative care of patients after surgery is similar whether the purpose of the surgery is experimental or not. However, if there are numerous sets of vital signs, speci- men collections, etc., the care of the patient becomes more consuming of nursing time.

The budget of a nursing department frequently is the largest in the hospital. During times of financial constraint, this budget may be reduced, allowing for onIy minimal patient eare. With the prospective payment systems, nursingcare time is a resource to be used in a cost-effective manner. At times of double shifts and overtime, for nurses topar- ticipate in research is not a high priority.


There will be missing data and patients who have not been entered into the study. Inves- tigators who initiate studies and come back at the end of the data collection period will be sorely disappointed. In contrast, investigators involved on a daily basis will be able to assess changing priorities in a unit and as- sure data collection.

Since the formulation of research policies, the approach to nursing involvement in data collection activities for medical research is to require that the investigator negotiate this involvement. The decision-making occurs at a level above the head nurse. This individual will have knowledge about whether staff from one unit may need to be moved to another unit and knowledge that may not be had by the head nurse of a unit.

Mayer (1980) stated the role of nurses in medical research cannot be taken for granted. If the nursing component of the project is substantial, perhaps coauthorship should be considered. She also said if nursing participation is desired, the chief nurse

executive should be consulted and approve participation.

In summation, nurses and physicians can interact for research in several different ways. Some are positive and some negative. Even the negative ways can be channeled into positive ways through communication. The outcome is more data of a higher quality which will yield results to improve patient care (Mechanic & Aiken, 1982).

REFERENCES Davis, M. Z. (1981). Promoting nursing research in

the clinical setting. The Journal of Nursing Ad- ministration, 1 1(3), 22-27.

Mayer, G. G. (1 979). Nurses’ participation in medical research. (Responses to letter, 1980, 302, 62- 63.) New Engtand Journaf of Medicine, 30 1,435.

Mechanic, D., & Aiken, L. H. (1982). A cooperative agenda for medicine and nursing. New England Journal of Medicine, 307, 747-750.

Noble, M. A. ( 1 980). Teaching clinical research: Ide- alism versus realism. Journal of Nursing Educa- tion, 19(2), 34-37.

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Nurses and physicians must interact for valid clinical research