Figure I. Nurse practitioner utilizing expanded skills.
Nurses provide a very intricate role in research protocols. They are tapped for their experience and resourcefulness to aid in completion of investigational research. Interdisciplinary activities, traditional nursing roles, and expanded skills are utilized (Figure 1). Nurses are a viable part of many investigational programs.
In 1974, the Western Council on Higher Education for, Nursing (WCHEN) set goals for the year; Goal No. 4 was adopted by the council, giving priority to clinical research.1 The following year, 1975, WCHEN reported that 85 institutions had nurse researchers, 50% of whom were in health care agencies.2
During the period of July 1978 through January 1979, this writer was assigned to a rheumatology division to do drug research. The study was designed to evaluate patient response to research medications used in treatment of ankylosing spondylitis. One of the major difficulties with that research project was obtaining patients for the study. In this current study of the elderly, this writer realized that in setting up the program the difficulties encountered previously had to be avoided. I feel that the procedure to be discussed in this article had a great bearing on the successful recruitment of study subjects.
This article demonstrates how the nurses' activity, roles, and interactions helped in recruiting and keeping patients in our long-term study. It describes programs implemented that helped decrease the subject drop-out rate.
The Aging Process Study has embarked on a five-year prospective study to evaluate the role of nutritional status in subsequent morbidity and mortality and to study the role of prostaglandins in the depressed immune response of the aged.3* The study is designed to follow 300 healthy individuals over the age of 65. Our criteria primarily is age and no chronic use of prescription medications. Certain nonprescription medications suc as an occasional antacid, analgesic, or sedative are acceptable. The researchers specifically screen for hyperglycemic agents, cardiac drugs, hypertension medications, steroids, and medications that interfere with prostaglandin metabolism. Persons on these medications are excluded from the study.
In this five-year study it is proposed to have a home visitation program that will provide a vehicle of patient contact. The home visitation team is made up of a nurse, dietitian, andaudiology technician. Scheduling of this team will depend on environmental factors and research protocol designated by the director.
Difficulties Encountered During Subject Recruitment
The criteria for patient selection in our study limited our recruitment program. We realized that hospital outpatient clinics would not be a source due to the fact that those patients would be on medication and not healthy. We were seeking a minority of the aged-the healthy person. Our enrollment would come from the elderly that did not visit hospital outpatient clinics or health related agencies.
The healthy person over 65 is usually active in the community and has a defined circle of friends. Many of these people belong to local senior citizen centers, thus establishing what we felt would be a source of subject enrollment.
In setting up the program the following phases were used. Phase I, or the development state, consisted of setting up the physical structure of the program. Subject charts were designed, examination rooms established, an appointment card system implemented, and identification cards and posters printed. Patient awareness programs were formulated and presented in various centers in the community.
The intermediate phase was for subject contact. Screening of subjects was accomplished during this phase and at the same time the criteria for participation was clarified. Objectives of investigation were defined to the volunteers. An advisory committee of volunteers was organized and implemented in this phase. Once the subjects demonstrated a willingness to participate in the study they could be approached to serve on the advisory committee.
This phase was predominately the basis of the program-the assessment, planning, and implementation phase. Within this phase was the period of data collection and coordination of activities. A large percentage of investigational data was accumulated during this stage. The ongoing continuing education programs for subjects was accomplished. Channels of researcher-subject communications were maintain during this period.
Current Methods of Patient Awareness
Initial recruiting for volunteers in the project was achieved through newspaper articles and photographs published in local newspapers. About 37% of our currently enrolled patients were recruited as a result of newspaper coverage. A statewide television talk show interviewed our principle investigator to inform the community about this research being conducted at the university hospital. A small percentage of patient enrollment resulted from the television exposure (see Figure 2).
Program Developed Patient Awareness
A large number of volunteer enrollment was the result of a article in a "Senior Citizen Newspaper." Since the primary concern was to reach the healthy elderly, an article was prepared by the public relations staff at the university health science unit and distributed through the senior newspaper which has a mailing list of people over the age of 55. The newspapers were distributed to senior centers, nutritional site programs, retired persons organization meeting places, and other areas where clientele are persons over 65 years of age. The health media department developed a poster specifically prepared for the elderly. An 11" x 17" poster with large print5 and short, concise statements was used (Figure 3). In addition, a specific contact person was designated on the poster. An educational session was arranged with the resource workers of the Mayor's Commission on Aging before the posters were dispersed. The sessions consisted of information about the study and criteria needed by volunteers to qualify for the study. The posters were then distributed by these community resource people to specifically designated areas.
Figure 3. Poster advertising the Aging Process Study.
A team, composed of a physician and nurse associated with the study, was available to the educational specialists of the office of senior affairs. That team made several presentations at local meal sites, housing for the elderly, Retired Seniors Volunteer Program (RSVP) meeting areas, and locations where persons age 65 and older would meet.
As a result of the patient awareness program, an employment agency for elderly persons offered to provide a listing of members registered in their program. This enabled the researchers to contact the members to evaluate their eligibility to participate in the study. The project director met with that organization's leader and clarified pro! oc ol.
The effectiveness ol the palian awareness program yielded numbers above those necessary for the study. The process needed to enlist subjects tapped the nurses' ability to function in multiple roles. The nurse had to contact radio and news media personnel to coordinate and develop press releases. Arrangements for filming and picture taking sessions were also scheduled. The nurse was part of the traveling educational team utilized by community agencies to provide patient education sessions. Often the nurse functioned as a liason between the research project and local agencies. The primary contact for these agencies and individuals was the nurse. Program scheduling was achieved by contacting the nurse. There are many roles that the nurse functioned in during the patient awareness program-roles that are not in the traditional roles of nursing.
Protocol Problems Encountered
The research study is also evaluating immune response6 of subjects in the study. Some of our subjects initially hesitated to have skin tests. The procedure had to be clearly discussed by the nurse. We also recommended to our subjects that they consult with their private physician prior to submitting to skin testing. The nurse was solely responsible for reading results of the skin tests. Home visits were made in special cases. The home visits helped in promoting visibility of our study. Feedback from subjects was positive in that it demonstrated concern and flexibility of our research group.
An identification card was given to each subject on their first visit. The identification card helped in facilitating communication channels between the research staff and the medical community.
The outpatient clinical research center is located in a large university center hospital where parking is a problem for employees and patients. Arrangements were made with hospital administration and security officers at the site of the research facilities to provide parking that eliminated barriers7 for the elderly. As a result of this parking program, which was recommended by the advisory committee and implemented by the staff, subject involvement was improved. Appointment increase was demonstrated. A scaled diagram (map) was mailed to subjects making them aware of the special parking available. Security personnel were instructed to direct and aid the elderly in finding the spaces available.
Programs Implemented to Decrease Patient Drop Out Rate
Several months after the research project was initiated, a general patient meeting was scheduled. The purpose of the meeting was to reestablish communication lines with the subjects. It was also an ideal opportunity to identify to the volunteers the ancillary support members of the program.
A continuing education program was planned and accumulated research data was discussed. It also provided a means whereby volunteers and patients could make suggestions and have specific questions answered. It was also an effective vehicle for sharing proposed future protocols associated with the study.
Letters were mailed to all active participants of the study. The letters informed patients of meeting place, time, and date. We scheduled the meeting during daylight hours because of the visual problems of the elderly.8 Special prearranged parking facilities were available close to the meeting place. The nurse was present to introduce patients to other members of the staff working in the project. The patients also had someone to identify and associate with. In the letters mailed, a map was enclosed to orient patients as to location of meeting and parking areas.
These periodic educational sessions have provided a continuous source of patient enrollment as a result of peer recommendations. New patients enrolled in the program after the meeting have voiced that they heard about the program at those meetings. In some cases they had accompanied a friend to the educational meeting.
The proposed length of the research program is five years. The researchers have created an advisory committee composed of patients in our study to help staff in decision making procedures. Actively enrolled members of the study were recruited. Selections were based on the following criteria: (1) involvement in a senior citizen center; (2) noninvolvement at centers; (3) commitment to meet periodically; and (4) willingness to become members of the committee. The advisory committee was contacted to evaluate proposed meeting sites of general patient sessions. The project director chaired the committee and was responsible for duties/procedures recommended by the committee. On occasions the committee met to prepare agenda for annual sessions. Periodically telephone contact was made with those members for input of a newly proposed study activity. It is felt that with active involement of study patients, other members would feel that they were represented by their peers. The advisory group had equal numbers of males and females. The suggestions by the committee were valuable primarily because of personal awareness with the problems associated with the elderly
The stages discussed earlier, ie, the development, intermediate, and long-term phases provided a systematic approach to fulfilling protocol activities. Programs have to provide flexibility that will allow adjustments that are mutually beneficial to subjects and researchers. Rigidity of programs can interfere with the ultimate program goals.
Considerations of prototype subjects need to be evaluated. If studies are based on the elderly, one must be aware of typical problems encountered by that group of people. Obstacles such as decreased visual acuity and other barriers that influence compliance with protocols have to be recognized. Advisory groups need to be developed in which subjects have an active role and can make suggestions and/or recommendations for change. These groups also give patients the feeling that they, as well as peers, are personally involved in the investigation and in the decision making process.
Utilization of the media such as radio, television, newspapers, etc, need to be used effectively and aid in providing awareness of research programs. Community resources and coordination of centers or organizations is also a vehicle for dissemination of information to the public. Posters properly prepared and systematically circulated into the community are of great assistance. Community educational programs to clarify the purpose of the study provide visability that is very valuable. Study identification cards are useful. Subjects as well as health-care providers for patients found that the staff of the research project were easily located and identifiable. The cards need to be specifically designed so that pertinent data is legible to the subjects with failing eyesight. Providing means of communication with the subject, personal involvement of the program, and visibility of the research group all contribute to the creation of a better investigatorsubject relationship that aids in maintaining the research protocol.
- 1. Elliott E: Research Programs and Projects of WGHEN. Nurs Res 26:277-280, July/August 1977.
- 2. Batey M: Communicating nursing research. Nursing Research in the Bicentennial Year 9:381-386. WIC.HE. 1976.
- 3. Goodwin JS, Bankhurst AD, Messner RP: Effects of prostaglandins on human T-cell mitogens. Existence of a prostaglandin producing suppressor cell. J Exp Med 146:1719-1734, 1977.
- 4. Todhunter EN: Lifestyles and nutrient intake in elderly. Current Concept Nutr 4:119-127. 1976.
- 5; Reichel W: In the Geriatric Patient. HP Publishing Co. Inc. 1976, pp 199-206.
- 6. Gershon RK, Kondo K: Infectious immunological tolerances. Immunol 21:903-914, 1971.
- 7. Pearson L, Kotthoff M: Geriatric Clinical Protocol. Philadelphia, JB Lippincott Co, 1974. pp 3-66.
- 8. Rossman I: Clinical Geriatrics, 2nd edition. Philadelphia, JB Lippincott Co. 1979. p 152