Hospice research: The importance of program participation Barbara Raudonis, RN, PhD Jane Marie Kirschling, RN, DNS
Abstract Hospice research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families. Hospice program participation is key to frture hospice research efforts. The purpose of this article is to encourage hospice programs to participate in hospice research. The discussion includes why research is done, who undertakes a research project, the role of institutional review boards in assuring rights of human subjects and potential strategiesfor recruitment of research subjects. The authors use their experiences with conducting hospice research to illustrate potential recruitment strategies. Introduction The care of terminally ill persons and their families has been influenced by the hospice movement in the United States. Within the past two decades the number of programs available to provide care has rapidly grown from one in 1971, to over 1,800 programs in
Barbara Raudonis, RN, PhD, Postdoctoral Fellow, Institutional NRSA, NR07048, Nursing Care of Older People, School of Nursing, Oregon Health Sciences University, of Portland, Oregon. Jane Marie Kirschling, RN, DNS, is Associate Professor, Family Nursing, Oregon Health Sciences University School of Nursing, Portland, Oregon.
1991 (personal communication, National Hospice Organization, February 19, 1992). During the past 10 years research efforts focused on hospice care have also increased. Yet, additional research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families or friends. Potential areas for exploration include, but aren’t limited to only symptom control, psychological and spiritual responses to a terminal diagnosis, the nature of interdisciplinary teams, the nature of therapeutic relationships, and/or interventional strategies for bereavement follow-up. The purpose of this article is to encourage hospice programs to participate in hospice research. Hospice programs need to understand the role of institutional review boards in assuring rights of human subjects. In addition, programs need to be aware of potential strategies for recruitment of research subjects. We will begin by briefly discussing why research is done and who undertakes a research project. This will be followed by information on institutional review boards and a discussion of strategies for recruiting appropriate subjects. Why research is done In principle, research is undertaken to expand our knowledge about a given subject. Research studies can be designed by a variety ofpeople, includ-
The American Journal of Hospice & Palliative Care July/August 1992 Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
ing clinicians, graduate students, educators, and researchers. For example, a hospice team member may observe that terminally ill persons with a specific disease have ongoing problems with skin breakdown. After exploring the literature and talking with other team members, the clinician may design a protocol for the prevention of skin breakdown with this patient population. The clinician, in collaboration with an experienced researcher,
In principle, research is undertaken to expand our knowledge about a given subject. could design a research study to evaluate the effectiveness of the new protocol in preventing skinbreakdown. Many graduate students have to complete a research project (e.g., class assignment, thesis or dissertation) in order to meet degree requirements. Often, students will design a research project to further explore an area that they have studied in class or that arises from their personal or clinical experiences. Research conducted by graduate students is typically supervised by at least one faculty member and often there is a committee that provides the student with direction.
21
The third group, educators and researchers, also design and implement research studies. Usually these individuals will have developed a program of research on a specific area and the proposed study is part of the larger research program. Hospice staff need to have a clear understanding of the qualifications of the person requesting to use the program as aresearch site. Whenever possible, hospice staff should meet with the person making the request on at least two occasions. This allows all participants to gain a better understanding of what is being proposed. In the case of student research, hospice staff should not hesitateto ask that the faculty member supervising the research experience be involved in the initial discussions. Irrespective of the person making the request, hospice programs need to be assured that subjects’ human rights will be protected. This is true whether the potential subjects are members of the interdisciplinary team, hospice patients, or their families. Institutional review boards Institutional review boards (IRB) are mandated by the federal government for the purpose of protecting the human rights of all persons participating in biomedical and behavioral research.1 Any institution from which a researcher applies for federal support must have an IRB. Based on this concern for human rights, most funding agencies, foundations, and health service agencies have developed research review boards.2 The establishment and functions of IRBs are regulated by guidelines and procedures developed by the various federal agencies providing monetary support. IRB membership consists of representatives from various groups (e.g., physicians, nurses, lawyers, administrators, educators, clergy) and the general public. IRBs are primarily responsible for reviewing proposed re-
22
volves two elements: information and consent.8 Researchers must provide appropriate information about the study, what is expected of the potential subject and what will be done with the information obtained. Specifically, the following information must be included in the researcher’s explanation: the purpose, procedures, amount and type of possible risks or discomfort, potential benefits, assurances of confidentiality, and an opportunity for the potential subject to ask questions.9 A verbal explanation accompanied by a written consent form that includes the above elements is the usual mechanism for providing information during the process of obtaining an informed consent. A sample consent form is provided in Figure 1. In addition, the researcher must provide an environment in which the potential subject can make a completely voluntary decision without any coercion.4’1° Cassidy and Oddi’°also identify the, “capacity to consent,” as a critical issue in the informed consent process. Capacity to consent is defined as whether the person giving consent possesses the legal capacity to do so. If such a capacity is lacking or in doubt then no consent can be legally given. If the individuals understand the information presented to them and are able to weigh the risks and benefits, then the consent is considered valid. As researchers work to acquire new knowledge, IRBs strive to establish high standards for conducting research, justly applying those standards to all proposals, and vigilantly protecting the dignity of the human subjects involved in the research.’°” When presented with a research proposal that has been approved by the investigator(s)’ IRB, the hospice program can assume that the proposal has been peer reviewed and the mechanisms to ensure the rights and dignity of the potential subjects have been established. Although the decision to participatein research is
search studies and monitoring ongoing studies. Research proposals are reviewed for specific measures that assure human rights and dignity. The principles of autonomy, self-determination, rights of privacy, confidentiality, anonymity, safety, and riskbenefit relationships are examined during an IRB review of a research proposal.3 In addition, IRBs evaluate the researcher’s qualifications to assess the risk-benefit relationship for the
Hospice staffneed to have a clear understanding ofthe qualifications of the person requesting to use the program as a research site. subjects, the researcher’s ability to conduct the proposed study, and the scientific merit of the research proposal.”4 The process of obtaining an informed consent is carefully reviewed by an RB, especially if the proposed subjects are members of a vulnerable population. Examples of vulnerable populations include captive groups (prisoners); acutely ill and dying patients; mentally and legally incompetent persons; fetuses; small children; the elderly, as well as the poor; the institutionalized; and those without family or significant others.5’6 Informed consent is based on the principle ofautonomy. Making autonomous decisions are considered a human right. According to Davis, respect for persons is the larger principle providingthe philosophical context for autonomy. Therefore, researchers are obligated to, “engage in the informed consent process with an attitude of respect for persons and in ways that permit patients to exercise their right to make autonomous decisions.”7 The process of informed consent in-
The American Journal of Hospice & Palliative Care July/August 1992
Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
Figure 1. Sample consent form. A study of how nurses understand the needs and experiences ofhospice patients My name is Barbara Raudonis and Iam a doctoral student at The University of Texas at Austin, School ofNursing. You are invited to participate in a study of the interaction between nurses and hospice patients. I hope to learn more about how nurses understand hospice patients, their needs and what that understanding means to the patients. You were selected as a possible participant in this study because you are receiving care from (NAME OF AGENCY) and you are an adult over the age of 18. You will be one of approximately 20 men and women chosen to participate in this study. The study is the basis of my dissertation and is part of my program of work for my doctoral degree in nursing. Ifyou decide to participate, I will ask you to take part in 1-3 interviews designed to tell me more about the interactions between hospice nurses and patients. During the interviews I will ask you questions about your experiences as a hospice patient, how the nurse recognized your needs, what the nurse did in order to understand you and your needs, and your feelings when you really felt understood. The interviews will be approximately 30 to 60 minutes long, audio taped and I will also make some notes, The interviews will be scheduled for a time that is convenient for you. The tapes will be coded so that no identifying information is on the cassette, they will be kept in a secure place such as a locked file cabinet and will only be heard by me. The tapes will be transcribed using only code numbers. No names or personal identifying information wifi appear on the transcriptions. At the end of the study the tapes will be kept and used for research purposes only. Again the tapes will always be stored in a locked file cabinet without any way of identifying the subjects. There is no monetary compensation for your participation in the study. Towards the end of the study I wifi be recontacting some of the participants regarding my impressions of the information given me by the study participants. Ifyou are recontacted, I will ask if you are willing to participate in a short interview to clarify some information. Some people become uncomfortable and nervous when they answerquestions aboutthemselves, their thoughts and their feelings. Other people find these kinds of questions are helpful in learning about themselves. Participating in this study may give you asense of satisfactionin knowing that you helped me learn more about how hospice patients experience interactions with hospice nurses but it will have no direct effect on you or your care as a hospice patient. As a practicing registered nurse I have the clinical skills with which to assess your condition in case of fatigue or distress. Ifyou experience any such signs Iwill stop the interview, assess the situation and call your hospice nurse if needed. Ifyou are tired or wish to stop the interview for any reason after any length of time we will do so. if you wish to continue the interview at another time, we will schedule another meeting. No information that can be identified with you will be given to anyone at (NAME OF AGENCY) or to your hospice nurse or anyone else not connected with this research study. Any information that is obtained in connection with this study and can be identified with you will remain confidential and will be disclosed only with your permission. Your decision whether or not to participate will not prejudice your future relations with The University of Texas or (NAME OF AGENCY). If you decide to participate, you are free to discontinue participation at any time without prejudice. If you have any questions, please contact meat (PHONE NUMBER) or my supervising professor, (NAME, PHONE NUMBER). You will be offered a copy of this form to keep.
You ate making a decision whether or not to participate. Your signature indicates that you have read the information above and have decided to participate. You may withdraw atany time without prejudice after signing this form, should you choose to discontinue participation in this study. Participant’s signature
______________
Date
Researcher’s signature
_____________
Date
The American Journal ofHospice & Palliative Care July/August 1992 Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
an individual decision made by each hospice respectively, we suggest that an understanding of the IRB purposes and procedures will facilitate and encourage participation in research.
Thepurpose of initial contact was only to determine the willingness of the hospke patient to be contacted by the researcher; it was not a consent to participate Recruiting subjects Research studies that have been approved by IRBs will include a description of how subjects will be recruited and measures for assuring their human rights. (Our experiences with conducting hospice research will be used to illustrate potential effective recruitment strategies.)12’6 Dr. Raudonis utilized four home care hospice agencies in two states to gain access to potential subjects. The purpose ofthis naturalistic study was to describe the nature, meaning and impact of empathy from the hospice patient’s perspective. Fourteen subjects were interviewed in their homes. After an orientation to the study and an explanation of the selection criteria, hospice nurses providing direct care identified which, if any, of their patients were potential subjects. Hospice nurses made the initial contact with patients regarding the study. They gave a brief explanation to patients in addition to a brief explanatory letter developed by the researcher. The purpose of this initial contact was only to determine the willingness of the hospice patient to be contacted by the researcher; it was not a consent to participate in the study.
23
If willing to be contacted, patients filled in their telephone number, and signed and mailed a self-addressed postcard to the researcher. Upon receipt of the postcard, the researcher called the hospice patient and explained the study and time commitment. If the patient was willing to participate, a mutuallyconvenient time for the interview was scheduled. Patients who chose not to participate were thanked for their time and consideration and no further contact was made. During the initial three months of data collection only one interview resulted from four returned postcards. Based on this rate of participation, it was necessary to broaden the base of the sample. Three other hospices were contacted including one in another state. Slight variations in the process of informing the researcher about potential subjects were negotiated with each program. In all cases, however,hospice nurses made the initial contact and the researcher madedirect contact with the potential subject only after permission had been given. During 14 months of data collection, 25 potential subjects were obtained from the four programs. Of these 25, 14 participated in the study, for a participation rate of 54 pereent. Dr. Kirschling has conducted two methodological studies with hospice programs in two states. The first study included qualitative research on concepts forwhich there were no appropriate existing measures. This study was conducted with one home care hospice program. Twenty family caregivers who were currently receiving hospice services, and 20 bereaved family members who were receiving bereavement follow-up services were interviewed. During 12 months of data collection, 36 caregivers who were currently receiving hospice services and 32 bereaved caregivers were invited to participate. The participation rates were 56 percent and 63 percent, respectively.
The second methodological study
24
was undertaken to test the reliability and construct validity of existing measures which had not been developed or tested with a sample of caregivers toterminally ill persons. Interviews were conducted with 75 family caregivers for terminally ill older
interview time. Informed consent was also obtained in person at the start of each interview. The major difference in procedures involved the identification of potential subjects and initial explanation of the study. Dr. Raudonis relied on hospice nurses providingdirect care to identify hospice patients who meet the criteria and explain the research study to potential subjects. Dr. Kirschling relied on a designated hospice staff member to review the caseload in its entirety and to refer potential subjects who met the criteria. These two approaches for subject recruitment differ in perspectives. Dr. Raudonis‘s procedures stressed the importance of empowering nurses providing direct care and involving them in the research process. Dr. Kirschling’s procedures stressed the importance of empowering the family in deciding whether or not to participate in the research and minimized the amount of time needed from nurses providing direct care. It is our belief that there is not one correct procedure for recruiting potential research subjects. Hospice staff need to realistically evaluate proposed procedures in terms of the time required of hospice staff, the importance of allowing potential subjects to make their own decisions, and the potential number of subjects that a researcher will be able to recruit during the proposed data collection period. It has been our experience that half of the referrals of hospice patients and their family caregivers will result in an actual interview. The other half chose not to participate, do not have time to participate, the terminally ill person is too ill, or they die before an interview can be arranged. In summary, hospice program participation is key to future hospice research efforts. Whether the research is conducted with patients, their families, or interdisciplinary team members, it is essential that the rights of human sub-
It is ourbelief thatthere is not one correct procedure for recruiting potential research subjects. persons receiving hospice care. A total of 164 referrals were obtained fromthe five hospice programs during the six months of data collection; 46 percent of the caregivers participated. The methods used for securing subjects in both methodological studies were the same. The researcher contacted the designated staff person in each hospice weekly to review the caseload. Families who met the criteria for inclusion were sent a letterby the researcher describing the study. At the same time, the researcher sent a note to the primary nurse and attending physician explaining the study and that the family had been sent a letter. The researcher contacted the designated staff member three days later to determine whether there had been a drastic change in the home or whether the family had requested (either by phone or through a nurse) not to be contacted by the research team. Once clearance was obmined, each family was contacted by phone to answer any questions and to set up a time to review theconsent form and proceed with the interview. The procedures used by Raudonis and Kirschling for recruitment of subjects share some similarities. We both initiated phone contact with potential subjects to explain our studies and if agreeable, to determine a convenient
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jects be protected. One established mechanism, Institutional Review Boards, can provide hospice staff with assurances that the proposed study and procedures do not violate human subjects rights. In order to successfully design and implement hospice research, it is important that hospice staff and researchers have ongoing dialogue and that each participant realistically address each other’s role in the research processU
References 1. Makarushka JL, McDonald RD: Informed consent, research, and geriatric patients: The responsibility of institutional review committee. The Gerontologist, 1979;19(l):61-66 2. Benoliel JQ: Considering human rights research. In Woods NF, Catanzaro M (eds.): Nursing research, theory and practice. St. Louis, Mosby, 1988:79-86 3. Munhall PL: Institutional review of qualitative research proposals: A task ofno small consequence. In Morse JM (ed): Qualitative nursing research: A contemporary dialogue. Rockvile, Aspen, 1989:241-253 4. Davis AJ: Ethical issues in nursing research. Western J Nursing Res, l979;1:l45-147 5. Davis AJ: Ethical considerations in gerontological nursing research. Geriatr Nursing, 198l;2:269-272. 6.Watson AB: Informedconsent ofspecial subjects. Nursing Res, 1982;3l(l):43-47 7. Davis AJ: Informed consent process in research protocols: Dilemmas for clinical nurses. Western J Nursing Res, 1989;11:448- 457 8. Beauchamp ii, Childress JF: Principles of biomedical ethics (2nd ed.). New York, Oxford Univ Press, 1983 9. Department ofHealth and Human Services: Basic HHS policy for the protection of human research subjects. Federal Register, 1981 ;46:8366-8392 10. Cassidy VR, Oddi LF: Legal and ethical aspects of informed consent: Anursing research perspective. J ProfNursing, 1986;2(6):343-349 11. Levine RI: Ethics and regulation of clinical research. Baltimore, Urban & Schwarzenberg, 1981 12. Raudonis BM: A nursing study of empathy from the hospicepatient’s perspective. Doctoral dissertation, The University ofTexas at Austin, 1991 13. Kirschling JM: Analysis of Bugen’s model of grief. The Hosp J, l989;5(l):55-75 14. KirschlingJM, Pittman JF: Measurement of spiritual well-being: A hospice caregiver sample. The Hosp J, 1989;5(2):1-ll 15. Kirschling JM, Tilden VP, Butterfield P: Social support: The experiences of hospice family caregivers. TheHosp J, l990;6(2):75-93 16. Yang CT, Kirschling JM: Exploration of factors related to direct care and outcomes of caregiving: Caregivers of terminally ill older persons. Canc Nursing in press;l5(3):
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Abstract Hospice research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families. Hospice program participation is key to frture hospice research efforts. The purpose of this article is to encourage hospice programs to participate in hospice research. The discussion includes why research is done, who undertakes a research project, the role of institutional review boards in assuring rights of human subjects and potential strategiesfor recruitment of research subjects. The authors use their experiences with conducting hospice research to illustrate potential recruitment strategies. Introduction The care of terminally ill persons and their families has been influenced by the hospice movement in the United States. Within the past two decades the number of programs available to provide care has rapidly grown from one in 1971, to over 1,800 programs in
Barbara Raudonis, RN, PhD, Postdoctoral Fellow, Institutional NRSA, NR07048, Nursing Care of Older People, School of Nursing, Oregon Health Sciences University, of Portland, Oregon. Jane Marie Kirschling, RN, DNS, is Associate Professor, Family Nursing, Oregon Health Sciences University School of Nursing, Portland, Oregon.
1991 (personal communication, National Hospice Organization, February 19, 1992). During the past 10 years research efforts focused on hospice care have also increased. Yet, additional research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families or friends. Potential areas for exploration include, but aren’t limited to only symptom control, psychological and spiritual responses to a terminal diagnosis, the nature of interdisciplinary teams, the nature of therapeutic relationships, and/or interventional strategies for bereavement follow-up. The purpose of this article is to encourage hospice programs to participate in hospice research. Hospice programs need to understand the role of institutional review boards in assuring rights of human subjects. In addition, programs need to be aware of potential strategies for recruitment of research subjects. We will begin by briefly discussing why research is done and who undertakes a research project. This will be followed by information on institutional review boards and a discussion of strategies for recruiting appropriate subjects. Why research is done In principle, research is undertaken to expand our knowledge about a given subject. Research studies can be designed by a variety ofpeople, includ-
The American Journal of Hospice & Palliative Care July/August 1992 Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
ing clinicians, graduate students, educators, and researchers. For example, a hospice team member may observe that terminally ill persons with a specific disease have ongoing problems with skin breakdown. After exploring the literature and talking with other team members, the clinician may design a protocol for the prevention of skin breakdown with this patient population. The clinician, in collaboration with an experienced researcher,
In principle, research is undertaken to expand our knowledge about a given subject. could design a research study to evaluate the effectiveness of the new protocol in preventing skinbreakdown. Many graduate students have to complete a research project (e.g., class assignment, thesis or dissertation) in order to meet degree requirements. Often, students will design a research project to further explore an area that they have studied in class or that arises from their personal or clinical experiences. Research conducted by graduate students is typically supervised by at least one faculty member and often there is a committee that provides the student with direction.
21
The third group, educators and researchers, also design and implement research studies. Usually these individuals will have developed a program of research on a specific area and the proposed study is part of the larger research program. Hospice staff need to have a clear understanding of the qualifications of the person requesting to use the program as aresearch site. Whenever possible, hospice staff should meet with the person making the request on at least two occasions. This allows all participants to gain a better understanding of what is being proposed. In the case of student research, hospice staff should not hesitateto ask that the faculty member supervising the research experience be involved in the initial discussions. Irrespective of the person making the request, hospice programs need to be assured that subjects’ human rights will be protected. This is true whether the potential subjects are members of the interdisciplinary team, hospice patients, or their families. Institutional review boards Institutional review boards (IRB) are mandated by the federal government for the purpose of protecting the human rights of all persons participating in biomedical and behavioral research.1 Any institution from which a researcher applies for federal support must have an IRB. Based on this concern for human rights, most funding agencies, foundations, and health service agencies have developed research review boards.2 The establishment and functions of IRBs are regulated by guidelines and procedures developed by the various federal agencies providing monetary support. IRB membership consists of representatives from various groups (e.g., physicians, nurses, lawyers, administrators, educators, clergy) and the general public. IRBs are primarily responsible for reviewing proposed re-
22
volves two elements: information and consent.8 Researchers must provide appropriate information about the study, what is expected of the potential subject and what will be done with the information obtained. Specifically, the following information must be included in the researcher’s explanation: the purpose, procedures, amount and type of possible risks or discomfort, potential benefits, assurances of confidentiality, and an opportunity for the potential subject to ask questions.9 A verbal explanation accompanied by a written consent form that includes the above elements is the usual mechanism for providing information during the process of obtaining an informed consent. A sample consent form is provided in Figure 1. In addition, the researcher must provide an environment in which the potential subject can make a completely voluntary decision without any coercion.4’1° Cassidy and Oddi’°also identify the, “capacity to consent,” as a critical issue in the informed consent process. Capacity to consent is defined as whether the person giving consent possesses the legal capacity to do so. If such a capacity is lacking or in doubt then no consent can be legally given. If the individuals understand the information presented to them and are able to weigh the risks and benefits, then the consent is considered valid. As researchers work to acquire new knowledge, IRBs strive to establish high standards for conducting research, justly applying those standards to all proposals, and vigilantly protecting the dignity of the human subjects involved in the research.’°” When presented with a research proposal that has been approved by the investigator(s)’ IRB, the hospice program can assume that the proposal has been peer reviewed and the mechanisms to ensure the rights and dignity of the potential subjects have been established. Although the decision to participatein research is
search studies and monitoring ongoing studies. Research proposals are reviewed for specific measures that assure human rights and dignity. The principles of autonomy, self-determination, rights of privacy, confidentiality, anonymity, safety, and riskbenefit relationships are examined during an IRB review of a research proposal.3 In addition, IRBs evaluate the researcher’s qualifications to assess the risk-benefit relationship for the
Hospice staffneed to have a clear understanding ofthe qualifications of the person requesting to use the program as a research site. subjects, the researcher’s ability to conduct the proposed study, and the scientific merit of the research proposal.”4 The process of obtaining an informed consent is carefully reviewed by an RB, especially if the proposed subjects are members of a vulnerable population. Examples of vulnerable populations include captive groups (prisoners); acutely ill and dying patients; mentally and legally incompetent persons; fetuses; small children; the elderly, as well as the poor; the institutionalized; and those without family or significant others.5’6 Informed consent is based on the principle ofautonomy. Making autonomous decisions are considered a human right. According to Davis, respect for persons is the larger principle providingthe philosophical context for autonomy. Therefore, researchers are obligated to, “engage in the informed consent process with an attitude of respect for persons and in ways that permit patients to exercise their right to make autonomous decisions.”7 The process of informed consent in-
The American Journal of Hospice & Palliative Care July/August 1992
Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
Figure 1. Sample consent form. A study of how nurses understand the needs and experiences ofhospice patients My name is Barbara Raudonis and Iam a doctoral student at The University of Texas at Austin, School ofNursing. You are invited to participate in a study of the interaction between nurses and hospice patients. I hope to learn more about how nurses understand hospice patients, their needs and what that understanding means to the patients. You were selected as a possible participant in this study because you are receiving care from (NAME OF AGENCY) and you are an adult over the age of 18. You will be one of approximately 20 men and women chosen to participate in this study. The study is the basis of my dissertation and is part of my program of work for my doctoral degree in nursing. Ifyou decide to participate, I will ask you to take part in 1-3 interviews designed to tell me more about the interactions between hospice nurses and patients. During the interviews I will ask you questions about your experiences as a hospice patient, how the nurse recognized your needs, what the nurse did in order to understand you and your needs, and your feelings when you really felt understood. The interviews will be approximately 30 to 60 minutes long, audio taped and I will also make some notes, The interviews will be scheduled for a time that is convenient for you. The tapes will be coded so that no identifying information is on the cassette, they will be kept in a secure place such as a locked file cabinet and will only be heard by me. The tapes will be transcribed using only code numbers. No names or personal identifying information wifi appear on the transcriptions. At the end of the study the tapes will be kept and used for research purposes only. Again the tapes will always be stored in a locked file cabinet without any way of identifying the subjects. There is no monetary compensation for your participation in the study. Towards the end of the study I wifi be recontacting some of the participants regarding my impressions of the information given me by the study participants. Ifyou are recontacted, I will ask if you are willing to participate in a short interview to clarify some information. Some people become uncomfortable and nervous when they answerquestions aboutthemselves, their thoughts and their feelings. Other people find these kinds of questions are helpful in learning about themselves. Participating in this study may give you asense of satisfactionin knowing that you helped me learn more about how hospice patients experience interactions with hospice nurses but it will have no direct effect on you or your care as a hospice patient. As a practicing registered nurse I have the clinical skills with which to assess your condition in case of fatigue or distress. Ifyou experience any such signs Iwill stop the interview, assess the situation and call your hospice nurse if needed. Ifyou are tired or wish to stop the interview for any reason after any length of time we will do so. if you wish to continue the interview at another time, we will schedule another meeting. No information that can be identified with you will be given to anyone at (NAME OF AGENCY) or to your hospice nurse or anyone else not connected with this research study. Any information that is obtained in connection with this study and can be identified with you will remain confidential and will be disclosed only with your permission. Your decision whether or not to participate will not prejudice your future relations with The University of Texas or (NAME OF AGENCY). If you decide to participate, you are free to discontinue participation at any time without prejudice. If you have any questions, please contact meat (PHONE NUMBER) or my supervising professor, (NAME, PHONE NUMBER). You will be offered a copy of this form to keep.
You ate making a decision whether or not to participate. Your signature indicates that you have read the information above and have decided to participate. You may withdraw atany time without prejudice after signing this form, should you choose to discontinue participation in this study. Participant’s signature
______________
Date
Researcher’s signature
_____________
Date
The American Journal ofHospice & Palliative Care July/August 1992 Downloaded from ajh.sagepub.com at UNIV OF WINNIPEG on August 11, 2015
an individual decision made by each hospice respectively, we suggest that an understanding of the IRB purposes and procedures will facilitate and encourage participation in research.
Thepurpose of initial contact was only to determine the willingness of the hospke patient to be contacted by the researcher; it was not a consent to participate Recruiting subjects Research studies that have been approved by IRBs will include a description of how subjects will be recruited and measures for assuring their human rights. (Our experiences with conducting hospice research will be used to illustrate potential effective recruitment strategies.)12’6 Dr. Raudonis utilized four home care hospice agencies in two states to gain access to potential subjects. The purpose ofthis naturalistic study was to describe the nature, meaning and impact of empathy from the hospice patient’s perspective. Fourteen subjects were interviewed in their homes. After an orientation to the study and an explanation of the selection criteria, hospice nurses providing direct care identified which, if any, of their patients were potential subjects. Hospice nurses made the initial contact with patients regarding the study. They gave a brief explanation to patients in addition to a brief explanatory letter developed by the researcher. The purpose of this initial contact was only to determine the willingness of the hospice patient to be contacted by the researcher; it was not a consent to participate in the study.
23
If willing to be contacted, patients filled in their telephone number, and signed and mailed a self-addressed postcard to the researcher. Upon receipt of the postcard, the researcher called the hospice patient and explained the study and time commitment. If the patient was willing to participate, a mutuallyconvenient time for the interview was scheduled. Patients who chose not to participate were thanked for their time and consideration and no further contact was made. During the initial three months of data collection only one interview resulted from four returned postcards. Based on this rate of participation, it was necessary to broaden the base of the sample. Three other hospices were contacted including one in another state. Slight variations in the process of informing the researcher about potential subjects were negotiated with each program. In all cases, however,hospice nurses made the initial contact and the researcher madedirect contact with the potential subject only after permission had been given. During 14 months of data collection, 25 potential subjects were obtained from the four programs. Of these 25, 14 participated in the study, for a participation rate of 54 pereent. Dr. Kirschling has conducted two methodological studies with hospice programs in two states. The first study included qualitative research on concepts forwhich there were no appropriate existing measures. This study was conducted with one home care hospice program. Twenty family caregivers who were currently receiving hospice services, and 20 bereaved family members who were receiving bereavement follow-up services were interviewed. During 12 months of data collection, 36 caregivers who were currently receiving hospice services and 32 bereaved caregivers were invited to participate. The participation rates were 56 percent and 63 percent, respectively.
The second methodological study
24
was undertaken to test the reliability and construct validity of existing measures which had not been developed or tested with a sample of caregivers toterminally ill persons. Interviews were conducted with 75 family caregivers for terminally ill older
interview time. Informed consent was also obtained in person at the start of each interview. The major difference in procedures involved the identification of potential subjects and initial explanation of the study. Dr. Raudonis relied on hospice nurses providingdirect care to identify hospice patients who meet the criteria and explain the research study to potential subjects. Dr. Kirschling relied on a designated hospice staff member to review the caseload in its entirety and to refer potential subjects who met the criteria. These two approaches for subject recruitment differ in perspectives. Dr. Raudonis‘s procedures stressed the importance of empowering nurses providing direct care and involving them in the research process. Dr. Kirschling’s procedures stressed the importance of empowering the family in deciding whether or not to participate in the research and minimized the amount of time needed from nurses providing direct care. It is our belief that there is not one correct procedure for recruiting potential research subjects. Hospice staff need to realistically evaluate proposed procedures in terms of the time required of hospice staff, the importance of allowing potential subjects to make their own decisions, and the potential number of subjects that a researcher will be able to recruit during the proposed data collection period. It has been our experience that half of the referrals of hospice patients and their family caregivers will result in an actual interview. The other half chose not to participate, do not have time to participate, the terminally ill person is too ill, or they die before an interview can be arranged. In summary, hospice program participation is key to future hospice research efforts. Whether the research is conducted with patients, their families, or interdisciplinary team members, it is essential that the rights of human sub-
It is ourbelief thatthere is not one correct procedure for recruiting potential research subjects. persons receiving hospice care. A total of 164 referrals were obtained fromthe five hospice programs during the six months of data collection; 46 percent of the caregivers participated. The methods used for securing subjects in both methodological studies were the same. The researcher contacted the designated staff person in each hospice weekly to review the caseload. Families who met the criteria for inclusion were sent a letterby the researcher describing the study. At the same time, the researcher sent a note to the primary nurse and attending physician explaining the study and that the family had been sent a letter. The researcher contacted the designated staff member three days later to determine whether there had been a drastic change in the home or whether the family had requested (either by phone or through a nurse) not to be contacted by the research team. Once clearance was obmined, each family was contacted by phone to answer any questions and to set up a time to review theconsent form and proceed with the interview. The procedures used by Raudonis and Kirschling for recruitment of subjects share some similarities. We both initiated phone contact with potential subjects to explain our studies and if agreeable, to determine a convenient
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jects be protected. One established mechanism, Institutional Review Boards, can provide hospice staff with assurances that the proposed study and procedures do not violate human subjects rights. In order to successfully design and implement hospice research, it is important that hospice staff and researchers have ongoing dialogue and that each participant realistically address each other’s role in the research processU
References 1. Makarushka JL, McDonald RD: Informed consent, research, and geriatric patients: The responsibility of institutional review committee. The Gerontologist, 1979;19(l):61-66 2. Benoliel JQ: Considering human rights research. In Woods NF, Catanzaro M (eds.): Nursing research, theory and practice. St. Louis, Mosby, 1988:79-86 3. Munhall PL: Institutional review of qualitative research proposals: A task ofno small consequence. In Morse JM (ed): Qualitative nursing research: A contemporary dialogue. Rockvile, Aspen, 1989:241-253 4. Davis AJ: Ethical issues in nursing research. Western J Nursing Res, l979;1:l45-147 5. Davis AJ: Ethical considerations in gerontological nursing research. Geriatr Nursing, 198l;2:269-272. 6.Watson AB: Informedconsent ofspecial subjects. Nursing Res, 1982;3l(l):43-47 7. Davis AJ: Informed consent process in research protocols: Dilemmas for clinical nurses. Western J Nursing Res, 1989;11:448- 457 8. Beauchamp ii, Childress JF: Principles of biomedical ethics (2nd ed.). New York, Oxford Univ Press, 1983 9. Department ofHealth and Human Services: Basic HHS policy for the protection of human research subjects. Federal Register, 1981 ;46:8366-8392 10. Cassidy VR, Oddi LF: Legal and ethical aspects of informed consent: Anursing research perspective. J ProfNursing, 1986;2(6):343-349 11. Levine RI: Ethics and regulation of clinical research. Baltimore, Urban & Schwarzenberg, 1981 12. Raudonis BM: A nursing study of empathy from the hospicepatient’s perspective. Doctoral dissertation, The University ofTexas at Austin, 1991 13. Kirschling JM: Analysis of Bugen’s model of grief. The Hosp J, l989;5(l):55-75 14. KirschlingJM, Pittman JF: Measurement of spiritual well-being: A hospice caregiver sample. The Hosp J, 1989;5(2):1-ll 15. Kirschling JM, Tilden VP, Butterfield P: Social support: The experiences of hospice family caregivers. TheHosp J, l990;6(2):75-93 16. Yang CT, Kirschling JM: Exploration of factors related to direct care and outcomes of caregiving: Caregivers of terminally ill older persons. Canc Nursing in press;l5(3):
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