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Corresponding author: Susan J. Pressler, RN, DNS, Professor, University of Michigan School of Nursing, 400 N Ingalls, Ann Arbor, MI 48109 (e-mail: SPressle{at}umich.edu).
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Abstract |
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Objectives To describe the recruitment process during the first 18 months of a study being conducted to evaluate cognitive deficits in patients with chronic heart failure.
Methods Details of the recruitment process are described for 2 clinic sites.
Results A total of 4027 echocardiograms were screened at site 1 to evaluate eligibility. Of the 161 patients eligible, 61 (38%) were invited to participate, and 29 of the 61 (48%) completed the study. At site 2, four hundred thirty-seven medical records of patients were screened, resulting in 163 eligible patients (37%). The staff invited 70 of the 163 patients (43%) to participate, and 52 of the 70 (74%) completed the study. The refusal rate was 23% at site 1 and 21% at site 2.
Conclusions Successful recruitment in studies involving patients with heart failure often requires screening of a large group of patients.
As researchers continue to investigate ways to improve care for patients with chronic illnesses such as heart failure, identifying strategies to facilitate recruitment of patients is important so that adequate and appropriate samples can be recruited in the most effective and efficient ways possible. The recruitment process may be difficult and labor intensive, particularly when an investigator is interested in recruiting people with serious, life-threatening chronic illness, such as heart failure, who must meet strict criteria for inclusion in the study.
Even the high prevalence and incidence of such illnesses do not necessarily mean that a group of eligible and willing research participants will be available for studies. Therefore, in this article, we describe the results of the recruitment process during the first 18 months of a 4-year study titled "Cognitive Deficits in Chronic Heart Failure." The overall purpose of the larger study is to examine the types, extent, and severity of cognitive deficits among a group of 300 patients with chronic heart failure and to evaluate the relationship between cognitive deficits and health-related quality of life.3,4
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Methods |
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| Recruiting people with serious, life-threatening chronic illness for studies is difficult.
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The first site is a group of adult primary care medicine clinics affiliated with an urban county hospital. Providers at this site care for a large number of patients who are members of minority groups and patients who are indigent. The site is a practice-based research network site, and it is mandated that all recruitment for research studies there be done by the recruitment manager and research assistants employed by the site. This site has the advantage of having a large, computerized medical records system that is used to identify potentially eligible patients and the patients’ regularly scheduled visits to clinics. The data from all echocardiograms obtained during the previous 2 years at the study site were evaluated by using computer protocols to ensure that patients met the criteria for inclusion in the study and did not meet any of the exclusion criteria. The geriatrician on the research team (U.S.) reviewed all of the echocardiographic data to verify the eligibility of patients. The data manager then generated weekly lists of scheduled clinic visits of the final group of potential participants. The list was provided to the recruitment manager, who coordinated the research assistants in inviting eligible patients to participate in the study.
Potentially eligible patients with heart failure were approached by a site research assistant, who explained the study to the patients, gave them an informational brochure about the study, and informed them that they would receive a $50 incentive fee for participation. Patients who agreed to participate signed the informed consent statement, and their names and contact information were given to the investigators to schedule an interview. Brief information about patients who declined to participate, including the reason for nonparticipation, was entered into a master file.
| At one site, 139 patients were screened for every 1 patient enrolled in the study.
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The second site is a multidisciplinary specialty clinic in which care is provided to patients with advanced cardiovascular disorders. The site is affiliated with a tertiary, acute-care hospital network. Potentially eligible patients were identified through screening of the medical records of patients who had regularly scheduled visits in the next 2 weeks. The screening was completed by the study’s principal investigator (S.J.P.) and the research assistants funded by the study grant. The principal investigator or research assistants obtained a printed list of patients with regularly scheduled visits for the upcoming 2 weeks and reviewed the medical record of each patient on the list to determine eligibility.
The names of eligible patients for the week were given to the clinic nurses, who briefly explained the study, gave patients an informational brochure about the study, informed them of the $50 incentive fee, and invited their participation during a regularly scheduled clinic visit. The names and contact information for patients who agreed to be contacted were provided to the investigators for scheduling the full interview. Brief demographic data and the reason for refusal were provided to investigators for patients who refused participation; these data were maintained in a separate confidential data base. At this site, the informed consent form was provided by research assistants who were members of the research team, and the consent statements were signed immediately before the face-to-face interviews.
Patients at both sites who agreed to participate were contacted by data collectors from the research team to schedule the interviews. These data collectors were trained in strategies for recruitment and used a standardized method to explain the study in more detail. Some patients refused to participate when contacted by members of the team even though the patients had previously agreed to participate. This information was retained in the refusal database.
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Operational Definition |
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Results |
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). The research assistants at the site were able to invite 61 (38%) of the eligible patients to participate. Of the 61 invited patients, 44 (72%) agreed and signed the informed consent statement. A total of 29 of the 61 patients (48%) approached completed the full study interview. According to these data, approximately 139 echocardiograms were screened for every patient enrolled (4027 screened divided by 29 who enrolled and completed study).5
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). Of these 437 patients, 163 (37%) patients met the inclusion criteria, did not have any exclusion criteria, and were eligible for participation. The nurses at site 2 invited 70 of the 163 patients (43%) to participate. Of the 70 patients approached to participate in the study, 61 (87%) agreed to be contacted by the investigators. A total of 52 of the 70 patients (74%) approached at study site 2 have completed the study; several more were scheduled for interviews. According to these data, approximately 8 patients would need to be screened for every patient enrolled (437 patients screened divided by 52 who enrolled and completed the study).5
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. The mean age of patients who refused participation was 62 years (SD, 11; range, 40–80). A total of 9 women and 5 men refused; 9 patients were African American and 5 were white. The refusal rate was 21% (15 of 70) at site 2, and the reasons for refusal were similar to the reasons reported at site 1 (Table 3). The mean age of patients who refused was 68 years (SD, 13; range, 45–84). A total of 11 men and 4 women at site 2 refused to participate. Among the patients who refused, 12 reported their race as white and 3 reported their race as African American.
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Discussion |
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These rates are consistent with rates from other studies of patients with major health problems. For example, recruitment rates were 63% and 69%, respectively, among 230 women with lung cancer and 429 patients with prostate cancer and family caregiver dyads who were enrolled into clinical trials.6,7 In our study, patient- and system-related factors may have contributed to these differences in enrollment and completion rates.
| Patients’ reasons for refusing to participate did not provide information to improve recruitment.
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Site 1 provides care for many patients who are indigent, a situation that may have contributed to the lower recruitment and participation rates. Patients who lack adequate resources may be coping with social issues that preclude their taking part in studies.8 Review of the demographic data of patients who refused participation and their reasons for refusal does not provide sufficient information to make recommendations about improving recruitment. Given the highly symptomatic condition of heart failure, some patients may have been simply too fatigued to take on the responsibility of participating in a study, and managing their daily care was all they could do. The length of the interview may have been a factor because of the 90 minutes it required, although no patients reported that.
In addition to patients’ characteristics, the differences in recruitment may be attributable, in part, to the different recruiting strategies used at the sites. At study site 1, recruitment of participants depended on site employees who recruit patients for multiple studies. In a previous study of 1948 patients eligible for participation in a panel survey of elderly families with cancer, Neumark et al9 found that registered nurses were significantly more effective than paid study recruiters or site research coordinators in recruiting patients. The health-related aspects of a study must be explained carefully, and such explanations may best be provided by nurses and may influence participation rates. The trust that exists between patients and nurses may further contribute to higher rates of participation.10
| Multisite studies may facilitate recruitment of large samples but increase the complexity of recruitment.
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Several factors facilitated recruitment at site 2. The principal investigator was able to monitor recruitment on a weekly basis and work directly with staff for recruiting. The principal investigator visited the site at least every other week, a strategy identified as successful in other studies.11 A recruitment coordinator position was developed for site 2 to ensure that potential patients were screened and their names provided to the nurses so the patients could be invited into the study. The financial cost of recruitment was lower for site 2 because personnel were employed through the grant and fewer patients had to be screened to obtain participants.
| Use of a systematic method for reporting recruitment and refusal rates is encouraged in heart failure research.
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These results indicate that patients with chronic heart failure may be best recruited in settings where nurses involved in the patients’ care can initially invite patients to participate in studies. More patients with heart failure may be available in multidisciplinary specialty clinics than in primary care clinics, a situation that facilitates recruitment. However, recruiting from specialty clinics must be balanced with the need to recruit broader populations of patients. This dilemma will require investigators to make concerted efforts to solve it.
Our results also support the need for ensuring that adequate personnel, time, and budgetary resources are built into the recruitment phases of studies; multisite studies may facilitate recruitment of large samples but increase the complexity of recruitment. Although multisite studies increase costs, using multiple sites may be necessary when recruiting carefully characterized samples of patients with heart failure. Members of the research team must develop methods for recruitment that do not contribute to staff duties of care. Collaborative relationships with health care institutions, such as appointments as coinvestigator or adjunct faculty, may facilitate recruitment efforts. In the current study, recruitment has been expanded to 5 sites.
Investigators working in heart failure research are encouraged to use a systematic method for reporting recruitment and refusal rates such as those proposed by Gross et al.5 Three reasons justify this recommendation. First, knowledge about the patients enrolled in a study is critical to the internal and external validity of a study, particularly clinical trials. These data will become increasingly important as the national agenda for translation of research results into practice moves forward.12 Second, this information is needed by investigators to find the best way to minimize any undue stress on respondents when working with these patients. Finally, this knowledge will allow investigators to allocate resources appropriately when planning and conducting studies.
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ACKNOWLEDGMENTS |
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FINANCIAL DISCLOSURES
This study was funded by grant R01NR008147 from the National Institute of Nursing Research.
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