Health Education Research Advance Access originally published online on September 8, 2006
Health Education Research 2007 22(3):361-371; doi:10.1093/her/cyl095
Recruitment and retention of Latinos in a primary care-based physical activity and diet trial: The Resources for Health study
1 Cancer Prevention Research Centre, School of Population Health, University of Queensland, Brisbane 4006, Australia
2 Colorado Health Outcomes Program, University of Colorado Health Sciences Center, Denver, CO 80262, USA
3 Center for Research Strategies, Denver, CO 80203-1694, USA
4 Clinica Campesina Family Health Services, Denver, CO 80203, USA
* Correspondence to: E. G. Eakin. E-mail: e.eakin{at}sph.uq.edu.au
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Abstract |
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Mandates to include women and minority populations in research have heightened the need to identify successful recruitment strategies. This paper describes the recruitment and retention strategies used as part of a randomized controlled trial (RCT) of a physical activity and dietary intervention targeting low-income, predominantly Latino patients in a primary health care clinic. Data on the recruitment and retention rates and the representativeness of participants are presented. Strategies included hiring bilingual staff, translating and culturally adapting intervention materials and soliciting ongoing consultation from patients, clinicians and organizations providing services to the Latino community. The primary recruitment procedure involved letters from physicians followed by phone calls from project staff to patients identified from electronic medical records. Two hundred patients were recruited into the RCT (78% of those reached and eligible), with 69 and 81% reached for the 6-week and 6-month follow-ups, respectively. Women were more likely to both participate and remain in the trial, and there was a trend toward greater recruitment and retention of Spanish speakers. By engaging the community, clinicians and patients, this study was able to successfully recruit and retain a large proportion of this often difficult to reach Latino sub-population of patients with multiple chronic conditions.
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Introduction |
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With an accumulating body of evidence on the disparities in health outcomes between whites and non-whites in the United States [1, 2], there has been increased attention to inclusion of non-white populations in research. Many funding agencies now require inclusion of women and minority populations, and indicate that increased cost associated with recruiting these groups is not an adequate reason for non-compliance [3].
Since such mandates have been implemented, there has been a great deal of literature outlining barriers to recruitment of minority populations and identifying strategies to overcome these barriers [4–10]. Barriers include lack of trust and ‘hassles’ of participation [6, 7], lack of transportation [10–12], lack of time and lack of culturally competent research [4].
Strategies that researchers have employed to increase overall recruitment and retention in research studies are numerous—indeed, many researchers advocate using multiple recruitment methods within any given research project to increase participation [10, 11, 13, 14]. Strategies currently regarded as ‘best practice’ in the recruitment and retention of minorities include developing trust with the target community by being visible during times when data are not being collected and by making contributions to the community that do not directly impact research [7], understanding cultural and social dynamics of the population under study prior to investigation [3], hiring and training lay people from the community or persons who are culturally competent [4, 7], offering to complete study requirements in convenient locations and sharing study findings with participants [6, 7, 15].
However, a current limitation of the literature is a dearth of detailed reporting on recruitment and retention strategies and related outcomes [16, 17], particularly in relation to minority or other disadvantaged subgroups [18]. Restrictions on the length of most reports of the outcomes of health behavior interventions limit the ability to address these issues in any detail. This paper reports on the recruitment and retention strategies used for a lifestyle intervention study targeting physical activity and healthy eating in low-income, predominantly Latino patients from an urban community health center. The paper is not an experimental evaluation of different strategies, but rather a detailed report on the implementation of best practice strategies, and presentation of results pertaining to the recruitment and retention rates achieved, and the representativeness of participants.
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Methods |
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Setting, participants and intervention
The Resources for Health study was a randomized controlled trial (RCT) of a physical activity and diet intervention and has been described in detail elsewhere [19]. Participants were randomized (by random number table) to an intervention or usual care group. The intervention group received two face-to-face meetings, three follow-up phone calls with a health educator and three tailored newsletters over a 6-month period to assist participants to make improvements to their physical activity and dietary intakes. The usual care group received standard non-health-related print materials. Data were collected at baseline, 6 weeks and 6 months. The intervention had been previously evaluated and shown to be effective with predominantly white, middle-income participants [20–22], as well as with white, lower income participants [23]. In the current study, it was adapted for use with predominantly Spanish-speaking, lower income participants.
The study was conducted at Clinica Campesina Family Health Services, a community health center providing primary health care services to primarily low-income and medically underserved individuals and families in the Denver metro area. The study took place at the urban North Denver clinic, the largest of the three clinic sites and the one with the largest percentage of Spanish-speaking clientele (
70% Spanish speaking). Potential participants were adults with one or more chronic conditions for which a lifestyle intervention focused on physical activity and diet would be appropriate (i.e. hypertension, chronic musculosketal pain, hypercholesterolemia, depression, type 2 diabetes, osteoarthritis, obesity, chronic lung disease, heart disease, osteoporosis, hepatitis, history of cancer, previous stroke, multiple sclerosis). Additional inclusion criteria were being 30 years and over, having a telephone and not planning to move from the area during the study's time frame.
Institutional Review Board (IRB) approval was initially received from the AMC Cancer Research Center IRB in January 2001, and renewed by the Colorado Multiple IRB (number 02-789) in December 2002 upon transfer of study personnel from AMC to the University of Colorado Health Sciences Center.
Formative work
Prior to study implementation, a number of steps were taken to adapt the study for use with the largely Spanish-speaking study population. These included hiring bilingual staff, translating study materials into Spanish, raising awareness of the study and soliciting input from clinic staff and engaging community input and support, as described below. This formative work was consistent with current best practice strategies in the recruitment and retention of minorities [3, 5, 7, 9, 14]. It was also driven by the social–cognitive [24, 25] and social–ecological theories [26] that underpinned the intervention; these theories emphasize understanding attitudes, knowledge and beliefs about physical activity and diet, as well as the social and environmental factors that may support or act as barriers to health behavior change [27]. The goal of the formative work was to inform the adaptation and implementation of the intervention for the low-income, Spanish-speaking target population of the study.
A study co-investigator (S.B.) and the project manager (K.R.), while both Caucasian, spoke fluent Spanish and had a significant amount of experience in working with Latino patients and research participants. A bilingual native Spanish speaker was hired as the study research assistant and a bilingual native English speaker was hired as the health educator. Both had significant experience in health promotion with Latinos and with translating of written materials.
Several steps were taken to adapt the Resources for Health intervention for a Latino population. All assessments were translated into Spanish and pilot tested with five patients from the target population for face validity and clarity. Results from psychometric testing of a translated version of one of the study outcome measures have been reported elsewhere [28].
Three discussion groups were conducted with a total of 25 Spanish-speaking clinic patients to gain feedback on the appropriateness of the physical activity and dietary behavior targets of the intervention. Results from these groups revealed that while there was a general acknowledgment of the importance of healthy eating and regular physical activity, intervention content and materials would need to (i) provide education on specific diet and physical activity guidelines; (ii) address healthy changes that could be made to the traditional Latino diet (e.g. substituting vegetable fats for lard); (iii) clarify the benefits of moderate forms of physical activity, as opposed to vigorous exercise, and (iv) address concerns about common barriers to physical activity (e.g. fear of injury, neighborhood safety, lack of time). Feedback from the groups with regard to the use of community resources to support their health behavior change (e.g. community-based exercise and diet groups) revealed the importance of cultural competency (i.e. that the sponsoring community organizations needed to provide a comfortable atmosphere for Spanish-speaking clients by having Spanish-speaking staff familiar with the local community). With the above incorporated into the intervention, the first intervention visit and accompanying materials were pilot tested for comprehension and appropriateness with an additional five patients, with no significant changes resulting thereafter.
Presentations about the study were made to all clinic staff prior to commencing the study, and regular updates were presented during the course of the study. All 12 clinicians in the clinic agreed to participate in the study.
Because a central focus of the intervention was to connect participants with resources in the community that could support their physical activity and diet goals, a community partnership group was formed that provided feedback and served as a source of information and referral about appropriate community resources. The group was formed by extending invitations to local organizations involved in providing support services to the local Latino community, including libraries, recreation centers, health service organizations, hospice care organizations, national volunteer organizations, senior centers and agencies providing services related to specific chronic conditions. Meetings were held approximately four times a year and were attended by 8–12 members. In addition to providing information about community resources appropriate for study participants, the group served as an information network, sharing information and resources on chronic disease self-management specific to the North Denver Latino community.
Recruitment procedures
Study recruitment began in February 2002 and continued for 19 months. It involved identifying patients from the clinic database who met basic eligibility criteria. Patients were sent letters signed by individual primary care providers describing the study and recommending participation. Included with the letter was a stamped, self-addressed postcard for patients to return to the clinic if they wanted to decline being contacted about the study. Patients, for whom postcards were not returned, were followed up within 1 week with recruitment phone calls. During this call, the study and randomization process were described, patients were screened for eligibility, questions were answered and consent was obtained. Baseline assessment was conducted on the same call if time allowed or was rescheduled as a last resort. Non-participating eligible patients were asked to give a reason for declining participation and to provide basic demographic details (as seen in Table I). This is the same recruitment procedure used in previous evaluations of the intervention on largely white patient samples, and which had resulted in high participation rates and representative patient samples [20–22].
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Additional efforts to raise awareness about the study included media announcements, newspaper articles and distribution of program flyers at community events and fairs, although these were not used as a direct means of participant recruitment.
Retention procedures
It was challenging to maintain contact with participants due to the transient nature of their lives. Phone numbers and addresses changed frequently within the 6-month duration of this study, numbers functional at the time of recruitment were disconnected by the time of the 6-week or final assessment and many participants traveled to Mexico for weeks or months at a time during their participation period.
Consistent with best practice in minority retention [3, 5, 7, 9, 14], several retention strategies were used to address the issue. Alternative contact numbers were requested at the baseline assessment and rechecked throughout the study. The study protocol called for at least 10 call attempts to be made per participant per contact at varying times of the day and days of the week, including evenings and weekends. Study staff repeatedly checked the clinic database and patient charts for updated phone numbers to replace disconnected or wrong numbers and made repeated attempts to re-contact participants who left the country for months at a time. To alleviate transportation difficulties for patients getting to the clinic for intervention visits, and for those who ‘no-showed’ multiple times, home visits were conducted. Wide time windows of 4–6 weeks were instituted around each contact point to allow for the greatest possibility of reaching participants. Participants still not reached after these efforts were discussed in study team meetings on a case-by-case basis to ensure that all possible avenues for reaching them had been explored.
Measures
The following information was collected as part of the baseline assessment of study participants: age, gender, number and type of chronic conditions, smoking status, ethnicity, education, income and validated measures of depression, physical activity and dietary behavior. A detailed description of study measures and the validity of their Spanish-language versions is described elsewhere [28].
Analyses
Statistical analyses were carried out with SPSS for Windows (version 12.0.1, 2003, SPSS, Chicago, IL) statistical software package. Continuous variables were normally distributed and are presented as mean ± standard deviation. Categorical variables are presented as counts and percentages. Chi-square tests, independent sample t tests and analysis of variance were used to compare characteristics between participants and non-participants and between participants with complete data, incomplete data and dropouts. Characteristics identified from bivariate analyses were considered in multivariable models to determine predictors of participants and dropouts using logistic regression analysis. Values are presented as adjusted odds ratios (ORs) with 95% confidence intervals (CI). Significance was set at the conventional P < 0.05 (two tailed).
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Results |
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Recruitment
Figure 1 shows the flow of individuals through the recruitment phase of the study. Six hundred and one patients were mailed recruitment letters, of which 56 (9%) returned postcards declining further contact. Four study-eligible family members of clinic patients were identified during recruitment calls and requested participation. They were linked with their family member (for randomization purposes) and added to the pool of potential participants, for a total pool of 605. Successful calls were made to 345 (62%) of the remaining patients, with an average of three phone calls (range = 1–26) needed to make contact. A total of 200 patients agreed to participate and completed baseline assessment (33% of the original pool of 605, 57% of those able to be reached by phone and 78% of those reached by phone and eligible for study participation).
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Table I compares characteristics of participants and eligible non-participants. Data for sex, language and age were obtained from the clinic database. On declining participation, non-participants were asked brief demographic and health questions; however, responses to these questions were obtained from only 37 of the 58 non-participants, and hence, the data on these variables come from this smaller sample. There were no statistically significant differences in age, ethnicity, education level and household income of participants and eligible non-participants. However, participants were more likely to be female and Spanish speaking. In addition, although not statistically significant, participants tended to be more likely to have three or more chronic conditions compared with eligible non-participants. Similar results were observed when participants were compared with non-contacted and ineligible patients (n = 347) based on data from the clinic database. That is, participants were more likely to be female and Spanish speaking, but did not differ with respect to age (data not shown).
When sex, language and number of chronic conditions were considered in a logistic regression model to determine characteristics of participants compared with non-participants, the associations previously observed disappeared, with only females being 2.16 (95% CI = 0.95, 4.92; P = 0.067) times more likely to participate.
Retention
Of the 200 patients enrolled, 137 (68.5%) were reached for the 6-week assessment and 162 (81.0%) were reached for the 6-month assessment. The intervention did not impact upon retention rates, with 71.3% intervention versus 65.7% usual care reached at 6 weeks (P = 0.447) and 83.2% intervention versus 78.8% usual care reached at 6 months (P = 0.474). Patient retention for the combined sample of intervention and usual care participants at follow-up assessments is shown in Fig. 2.
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Overall 63% (n = 126) of participants had complete data assessments (baseline, 6 weeks and 6 months). Characteristics of participants with complete data, incomplete data (missing either 6-week or 6-month assessment) and dropouts (missing both 6-week and 6-month assessment) are shown in Table II. Incomplete data were due to missed assessments at 6 weeks for 36 participants and at 6 months for 11 participants. Language is the only characteristic that was statistically significantly associated with completeness of assessments (P = 0.019). Significantly fewer Spanish speakers were dropouts.
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Although not statistically significant, compared with participants with complete and incomplete data, dropouts tended to be male, to be not married and to have three or more chronic conditions. When these variables were considered in a logistic regression model to determine characteristics of dropouts compared with patients with complete data, sex was the only variable to remain significant. That is, females were 2.78 (95% CI = 1.02, 7.58; P = 0.045) times less likely to be dropouts compared with males. There was a trend for Spanish speakers to be less likely to dropout compared with English speakers (OR = 2.48; 95% CI = 0.95, 6.54; P = 0.064).
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Discussion |
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TopAbstractIntroductionMethodsResultsDiscussionConflict of interest statementAcknowledgementsReferences |
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The Resources for Health lifestyle intervention trial was able to successfully recruit and, to some extent, retain a large and representative sample of predominantly Spanish-speaking patients with chronic conditions over the course of the 6-month trial. Strengths of this investigation include the careful tracking of each stage of recruitment, including collection of basic demographic data from eligible non-participants, such that the representativeness of study participants could be empirically evaluated, along with detailed reporting on recruitment and retention strategies. These issues are key to advancing our ability to successfully conduct research with minority participants [3, 29, 30].
Specific considerations for improvements in reaching and retaining minority populations gleaned from this study are multiple. With regard to reaching our study population, having a relationship with a health clinic serving the target audience was a critical consideration. This clinic has a history of employing research for quality improvement of clinic services, and thus, it was not a stretch for them to consider this a similar endeavor. As reported by others [10], the relationship with a clinic offering much needed services to the Latino community allowed us to have a high level of credibility for recruitment. The proactive recruitment procedure involving an initial letter from the physician—i.e. a trusted and known person—followed by phone calls from project staff, shown to be successful in other studies [20–23], was also likely a key factor in the success of recruitment.
With regard to recruitment, the importance of persistence and cultural proficiency cannot be overstated [10, 31, 32]. The biggest barrier to recruitment was reaching potential participants for an initial contact, with 37% of potentially eligible participants never reached by phone despite multiple contact attempts. Similar rates have been observed in studies using identical recruitment procedures targeting predominantly white, middle-class patients [21]. The inability to make even an initial contact with a large proportion of primary care patients reinforces the need for a multistrategy approach to promoting health behaviors in this hard to reach subgroup [26], as well as consideration of community-based participatory research strategies [33, 34] that have the potential for wider population reach and engendering greater trust in the Latino community. However, to be effective in reaching the Latino patients in this study, many of whom spoke little if any English, such approaches would need to be culturally and linguistically tailored.
It was encouraging to see that 78% of the reached and eligible sample was enrolled in the study. This compares favorably to participation rates in predominantly white, middle-class populations [21]. It is clear that once contact was made with potential participants, our staff were very capable of recruiting them. Having engaging and personable staff with the ability to relate to potential participants was invaluable in getting persons screened and enrolled.
However, detailed reporting on recruitment for studies including minority populations is limited, thus making comparisons with other minority-based studies difficult [30]. What has been consistently reported is that recruitment rates vary considerably based on the strategy used [15, 35]. For example, research studies recruiting minority women (including Latinas) have reported 84% enrollment rates with face-to face recruitment [15] and 67% when using print, television and radio advertising [36].
The current study also elucidated challenges and strategies related to retention of Latino participants for health research, particularly important because retention has received relatively less attention than recruitment and enrollment. Retention in this study proved difficult, with 69% reached at 6 weeks and 81% at 6 months. Despite a great deal of persistence, following the 10+ call attempts protocol, many participants were not reached at 6 weeks. This was a highly mobile and transient population—an important consideration for other researchers. In an effort to increase retention at 6 months, another part-time assistant was hired, and every effort was made to contact participants for follow-up, including 20+ calls for some. These retention rates are certainly less than those reported in other lifestyle trials targeting white, middle-class patients with chronic conditions, many of which achieve rates close to and sometimes exceeding 90% for follow-ups of 12 months or more [22, 37]. Further, they exemplify the need for additional staffing related to multiple contact attempts.
Multivariable analyses allowed for a detailed evaluation of the representativeness of those recruited and retained in the study. Results showed a consistent pattern across both recruitment and retention, namely, that females were more likely to participate and complete the study. The over-representation of females is consistent with the large literature on health promotion, in which it is not uncommon to see female participation rates of 70–80% [38, 39], as seen in this study. There was a trend toward better recruitment and retention of Spanish speakers; however, the number of English speakers may have been too low to allow an adequate assessment of the impact of language on recruitment and retention. Greater retention of females and Spanish speakers may have been influenced by the use of a female, native Spanish-speaking research assistant, who was the primary contact with patients throughout the study, as reported by others [10]. As with Caucasian samples, it remains a challenge to recruit Latino men into health promotion studies. Recruitment and retention of large numbers of Spanish speakers and those with multiple chronic conditions suggest that the strategies employed were successful in reaching the primary target population for the study and, arguably, those patients most in need of lifestyle intervention.
However, a limitation of the study is that it was not designed to empirically evaluate different recruitment and retention strategies. Instead, this paper described the strategies used and outcomes achieved in detail to address the dearth of such reporting with regard to studies targeting Latino participants. Other limitations include the short (6 months) follow-up period and the fact that it was conducted in only one clinic in the metropolitan Denver area serving those largely of Mexican descent. Thus, the results may not generalize to the many other culturally diverse Latino sub-populations across the United States or elsewhere.
Future research should include more consistent reporting on sampling frames, recruitment, eligibility, enrollment and retention for all RCTs of health behavior interventions with Latino populations [30]. This will provide a benchmark for evaluating whether interventions to reduce health disparities are reaching their intended targets [40].
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Conflict of interest statement |
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None declared.
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Acknowledgements |
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This work was funded by grant no. 041862 from the Robert Wood Johnson Foundation's national program on ‘Improving Chronic Illness Care’ (http://www.improvingchroniccare.org). We are grateful to the staff and patients of the Clinica Campesina Family Health Services for their support of and participation in this study. We also gratefully acknowledge the work of Kate Troy in assisting with data management and analysis.
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References |
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Received on October 23, 2005; accepted on July 17, 2006
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