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1 Nutritional Immunology Laboratory Jean Mayer/USDA Human Nutrition Research Center on Aging (HNRCA), Tufts University, Boston, Massachusetts.
2 Division of Geographic Medicine and Infectious Diseases, Tufts-New England Medical Center, Boston, Massachusetts.
3 Center for International Health and Development, Boston University School of Public Health, Massachusetts.
4 University of Sydney, Lidcombe, Australia.
Address correspondence to Simin Nikbin Meydani, DVM, PhD, Nutritional Immunology Laboratory, Jean Mayer/USDA Human Nutrition Research Center on Aging Tufts University, 711 Washington St., Boston, MA 02111. E-mail: simin.meydani{at}tufts.edu
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Methods. This report describes our experience in recruiting 617 nursing home residents for a multisite, double-blind, randomized, placebo-controlled trial designed to determine the efficacy of a 1-year period of vitamin E supplementation in preventing respiratory tract infections. Comparisons of the projected staffing costs and actual costs incurred are presented, using a retrospective method for the determination of unit costs.
Results. Initially, 874 consents were obtained from 2815 potential participants, of which only 617 were enrolled. Each successful enrollment required an average of 15 hours of staff time at a combined personnel and supply cost of $515 per participant and a total study cost of $317,661. Several obstacles were encountered during the recruitment and enrollment process: resistance on the part of family or primary care provider; transfer out of facility; and changes in the medical condition of the patient, including death.
Discussion. The results of this report should prove useful to investigators developing budgets for nursing home–based clinical trials by providing a more accurate determination of the personnel needed and the costs associated with recruitment and enrollment of participants.
Although there exists useful advice regarding ethical and practical issues associated with the recruitment of nursing home residents into clinical trials (3–5), little information is available for the required staff time and other costs associated with it. These estimates are necessary for the successful implementation of clinical trials in nursing homes.
We recently completed a randomized, placebo-controlled clinical trial designed to determine the effect of vitamin E supplementation on the incidence and duration of respiratory tract infections in elderly nursing home residents (6). We estimated recruitment costs in the original proposal based on the limited literature and our experience conducting nutritional research in healthy, community-dwelling elderly persons. As the study progressed, it became apparent that the personnel and costs needed to complete this trial had been largely underestimated. The purpose of this article is to provide the research community with data for more accurately projecting recruitment costs and personnel time for clinical intervention trials in elderly nursing home residents.
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STUDY METHODS |
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Identification and Recruitment of Nursing Homes
Prior to submission of the grant proposal, 15 Boston-area nursing homes were surveyed. We learned that most nursing homes would be receptive to the study as it was: 1) relatively noninvasive; 2) associated with minimal risk and possible benefit to the participants; 3) minimally burdensome for and at no cost to nursing home staff; and 4) potentially able to associate the home with an academic institution. However, due to high turnover of administrators and nursing personnel, only three facilities from the original sample participated in the study after it was funded.
The marketing approach to recruitment of homes for the study arose from a literature review (3–5) and our own observations during initial site visits. Resources to identify homes included assistance from an aftercare coordinator at New England Medical Center, nursing home directories published by the Massachusetts Department of Public Health (7), and our personal and professional associates.
Large long-term care facilities geographically close to our research center located in downtown Boston and smaller homes located within the city's ethnic neighborhoods were chosen for our marketing campaign. A marketing packet that included a cover letter, study brochure, abstract, and reprints of pertinent publications by the principal investigator, was mailed to the administrators and directors of nursing and medicine at each facility. Two weeks after the mailings, a follow-up phone call was made to the nursing director to determine interest and to schedule an informational meeting.
Successful meetings produced: 1) a letter of cooperation signed by the homes' administrator; 2) a letter co-signed by the homes' medical director and study physician informing the primary care providers (PCPs) of the study requirements; and 3) a scheduled date for in-service training with the homes' nursing staff.
Participant Recruitment
In-service sessions with staff nurses were held at each site to inform them of the study's significance, possible impact on health status of all elderly persons, study procedures, and eligibility criteria. Additionally, an overview of the research institution and qualifications of the research team, the noninvasive nature of the study, and the limited amount of work that would be imposed on the nursing home staff were emphasized. Assurance was given that staff was not expected to obtain informed consent or to perform additional documentation other than recording the daily supplement administration. Multitest CMI skin test kits (Merieux Institute, Inc., Miami, FL), used to determine immune response as part of the study objectives, and sample supplements were displayed at each meeting. Ample time was allowed to address any misperceptions or problematic past experiences that the nurses might have had with medical research.
Following each in-service session, the research team and nursing staff reviewed the resident list for potential eligibility. The research team briefly reviewed each candidate's clinical chart for contact information to notify families and the PCP that the patient was being considered for the study. A spreadsheet of patient information was created so that the research team could track the status of each potential candidate.
Notification to the PCP
The first step in the recruitment process was to send a letter, listing each patient candidate and co-signed by the medical director and a study physician, to each PCP. The letter included a description of the study and outlined its impact on the current care of the patient should the decision be made to participate. The PCP was advised to contact the nursing director if the patient was not a good candidate. The recruitment team waited 2 weeks to see whether the PCP objected before approaching patients or their proxies for consent.
Determining Competency of Eligible Patients
Nursing home staff made a preliminary determination of competency; however, further evaluation by the research team of the patient's orientation, memory, and judgment was required. Any ambivalence regarding these cognitive markers led the research team to obtain a consent co-signed by the candidate's guardian or closest family member.
Informed Consent
The research team visited all candidates who were considered competent and explained the study in general terms to ascertain interest and willingness to participate. Those interested were given the consent form to read. The research team read the consent aloud to those who were sight impaired. The resident was queried throughout the interview to ensure that the study purpose and procedures were understood.
The nursing home staff was hesitant to serve as witness to the consent process. Therefore, the presence of two research team members was required, one to review the consent form and the other to witness the process.
Letters co-signed by the nursing home administrator and Directors of Nursing and Medicine were sent to the next of kin or guardian of patients considered incompetent, informing them that the home was participating in the study, their relative was a potential study candidate, and a member of the research team would be contacting them. Enclosed with the letter were a study brochure, informed consent form, and a postage-paid return envelope.
Follow-up phone calls were made 2 weeks after the mailing. Repeat phone calls often had to be made if the family members had not been available, wanted time to speak to siblings about the study, or had misplaced or never received the materials. In most cases more than one mailing and several phone calls were required to ascertain the family's decision.
Over the phone, the research staff encouraged the family to ask questions about the procedures and risks involved. Those who agreed to enrollment were asked to sign the consent, have their signatures witnessed, and mail back the form in the return envelope. The consent forms included specific signature lines that denoted the family members' relationship to the resident, which was sometimes confusing, necessitating another round of mailings, with the appropriate signature line highlighted.
To determine the reasons for not granting consent, a sampling of families who declined enrollment were sent anonymous questionnaires and asked to rank several reasons for refusal to allow their relative to participate in the study.
Participant Rescreening
After obtaining informed consent, each potential participant was rescreened by a research nurse to confirm eligibility. The rescreening process consisted of a chart review, patient assessment, and height and weight measurements. Blood was drawn for the measurement of serum albumin. Patients with albumin levels <3.0 g/dL were excluded.
Determining Time and Costs for Recruitment
The time to carry out the aforementioned tasks and associated indirect costs were determined using a retrospective approach. The steps involved in the recruitment process were identified after enrollment (end of year 3), and each team member independently estimated the time needed to complete each step. These estimates were averaged and multiplied by activity data. The research team then evaluated the tasks for the purpose of assigning an appropriate personnel level to each. The following staff levels were thus identified and assigned to corresponding tasks: level 1, staff assistant; 2, phlebotomist; 2.5, graduate student; 3, recruiter; 3.5, research nurse; 4, study coordinator; 4.5, recruitment director; and 5, principal investigator and study physicians.
Salary and fringe benefits were determined for the 3 years of the project and an average hourly rate was calculated for each staff level. These rates were multiplied by the total number of hours used in completing each task. When a task required a range of staff levels, the three different hourly rates were averaged based on the participation level of the different types of study personnel.
Nonpersonnel costs associated with the study included recruitment materials, postage, office supplies, interpreter and translator charges, gifts to volunteers, nursing home staff educational opportunities and gifts, staff travel, and cell phone expense. The total recruitment cost was calculated by adding the personnel and supply cost, and then dividing by 617 (the number of enrolled participants) to determine the enrollment unit cost.
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RESULTS |
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Recruitment of Potential Participants and Informed Consent Process
Combined, the cooperating homes provided a total pool of 8026 residents, of whom only 2814 (35%) were initially believed to be eligible for the study. There were 1152 visits to competent patients in their respective nursing home by the study team resulting in 497 consents. Of the 1622 initial mailings to families of incompetent patients, only 60 families immediately returned a signed consent; the rest required an additional 3324 follow-up phone calls to obtain the additional 316 consents. Table 1 illustrates the result of these recruitment efforts.
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Rescreening
The rescreening process resulted in the rejection of 29% (n = 257) of those who had already provided consent. Table 3 shows reasons for rejection.
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The total time and cost for each phase of the recruitment process is broken down in Table 5. Personnel expenses accounted for 86% of the total cost, thus each successful enrollment required an average of 15 hours of staff time at a combined personnel and supply cost of $515 per participant and a total cost of $317,661.
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DISCUSSION |
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Because we did not anticipate an average of nine PCPs per home, the importance of effective communication with PCPs cannot be overly emphasized. The residents and their families wanted the assurance of knowing that their PCP had been informed and had approved the patient's participation. The most effective way to enlist the PCP's support proved to be the letter from the medical director and study physician, leaving the final decision to them to enroll their patients in the study. With a 29% rejection rate, the rescreening process revealed imprecision in the candidate list developed by the nursing home staff. Despite in-service training, some floor nurses were unable to select eligible candidates. Furthermore, their recall of a patient's medical conditions, micronutrient supplement consumption, antibiotic use, and influenza vaccine history was not always accurate. In general, it would have been preferable for a study nurse to develop the candidate list from a detailed record review.
Accurately assessing competency before seeking consent is a crucial factor in saving time and costs. Without a correct assessment, the research team's efforts were doubled, delaying recruitment by at least 2 weeks (the average time needed to contact family or health care proxy and to obtain consent). In addition, the recruiter occasionally experienced disagreement by the family with the team's assessment of the patient's competency; the family felt that their relative was capable of signing the consent. When the nursing home social worker was involved, competency assessments were more accurate. In addition, the social worker provided insight into those families who might be more receptive to the research. It is highly recommended, therefore, that clear objective criteria such as a paper and pencil test be used along with a social service assessment to better estimate competency and willingness, thus avoiding such setbacks and ambiguity.
Obtaining consent was the most labor intensive, logistically problematic phase of recruitment. The importance of not burdening nursing home staff with the responsibility of obtaining informed consent or carrying out study procedures has been previously noted (3). Furthermore, elderly nursing home residents may feel inappropriately coerced into study participation if nursing home personnel are involved in the consent process (4). We therefore did not ask the homes' nurses to assist with the informed consent process. However, our experience confirmed the findings of others (3–5) that cooperation with the nursing home staff was critical for successful resident recruitment. Their opinions proved influential in determining resident and family decisions to participate. It was, therefore, important to carefully prepare the in-service meeting content and address any negative perceptions on the part of the nursing staff toward medical research in general.
Using a recruitment and consent process similar to ours, Cohen-Mansfield and colleagues (4) reported a consent rate of 84% for competent residents. We were able to attain only a 57% rate of consent for competent candidates. Warren and colleagues (8) found that 54% of health care proxies agree to consent to research participation for the nursing home patient they represent. Table 1 demonstrates that our rate of 43% was lower than that reported in the literature. Multiple blood draws and intradermal skin tests may have dissuaded participation in both groups of candidates.
Our assumption that daily dispensing of study supplements was not an added burden to the nursing home staff was not applicable at all participating sites. One nursing home requested to terminate the study due to an acute personnel shortage—fortunately, that particular situation was successfully resolved. In addition, during the course of this study the Massachusetts Department of Public Health was citing homes that frequently prescribed more than eight medications per day per patient. Homes had to justify the additional supplements for study participants, so it was important that each was proved with study documentation addressing this issue, should it be raised in an audit.
Of the 617 participants enrolled in this study, only 36 (6%) represented minorities. Well documented obstacles to research participation by ethnically diverse people such as mistrust of research institutions and language were compounded by the fact that many minority cultures are less likely to institutionalize their elderly persons. In addition, we found that many homes lacked documentation of race in their clinical charts, thus making it difficult to identify potential minority participants. One nursing home composed of 99% elderly Chinese persons yielded only 8 of 100 potential participants, yet required translated consents and interpreters to assist the study nurse with weekly collection of study data. These additional requirements increased both the time spent by the research nurse and the study costs. This low yield may have been a reflection of the objection among elderly Chinese persons to having blood drawn (9).
Gaining acceptance of the study by the nursing home administration, educating the nursing home personnel, identifying potential study participants and determining their competency, obtaining consent from competent candidates and the health care proxies for incompetent residents, and performing rescreening procedures all consumed more personnel resources than had been estimated in preparing the study budget. The data presented here provide a retrospective assessment of the time and staff costs associated with recruitment and enrollment of nursing home residents in this intervention clinical trial. The result of this assessment indicates that enrollment of each participant required 15 hours of staff time at a cost of $515. The unit time and costs described above could be modified to meet the differing requirements of comparable studies.
This information should help investigators to develop better budget projections for similar types of clinical trials, as well as grant reviewers and administrators in evaluating the suitability of the requested budget for such proposals. In addition, we have put together a list of recommendations that can be found in Table 6.
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Received August 4, 2004
Accepted October 14, 2004
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| Journals of Gerontology Series B: Psychological Sciences and Social Sciences | |
