PREMIER was an 18-month multicenter randomized clinical trial to determine the effects of two multi-component lifestyle interventions, relative to an advice-only control condition, on blood pressure (BP) [8
]. Centers participating in the PREMIER trial included the NHLBI Project Office, the Coordinating Center (Kaiser Permanente Center for Health Research in Portland, Oregon) and four clinical centers (Johns Hopkins University, Baltimore, MD; Pennington Biomedical Research Center, Baton Rouge, LA; Duke University Medical Center, Durham, NC; and Kaiser Permanente Center for Health Research, Portland, OR). The PREMIER design and rationale [8
] and main results [9
] have been published.
The PREMIER trial aimed to recruit 800 adult men and women (half female, 40 percent African American, and 30 percent hypertensive), ages 25 and older, with a systolic BP of 120-159mmHg and diastolic BP of 80-95 mmHg. The rationale for choosing this BP range was to enroll persons who were candidates for non-drug intervention programs designed to reduce BP. Individuals with normal but above-optimal BP and those with stage 1 hypertension were therefore eligible to participate in the trial. Eligibility criteria excluded individuals who had health problems requiring immediate attention, or who were candidates for aggressive antihypertensive drug therapy. Each center received prior approval from their institutional review boards; an external protocol review committee approved the trial protocol; and each PREMIER participant provided written informed consent.
African Americans have a higher prevalence and greater severity of hypertension than other minorities (e.g., Mexican Americans) and Non-Hispanic Whites [10
]. Because of the disproportionate burden of hypertension in African Americans and because of the possibility that several intervention components (reduced salt intake and the DASH dietary pattern) may reduce BP to a greater extent in African Americans than in other groups [11
], about 320 (40%) of the 800 trial recruitment goal was set for this population. Baltimore, Durham, and Baton Rouge clinical sites each were to recruit 50% African Americans, while Portland was designated to recruit 10% of this population. As described below, PREMIER researchers, therefore, devised specific strategies to recruit African American participants and to deliver an intervention program that would incorporate their cultural perspectives.
Minority Implementation Committee
The PREMIER investigators placed a high priority on developing lifestyle interventions appropriate for African Americans at high risk for hypertension and obesity. A Minority Implementation (MI) committee with representatives from all clinical centers was therefore established in the PREMIER trial to address issues of importance in recruiting and retaining African American participants. The MI committee consisted of principal investigators, clinic coordinators, recruitment coordinators, a consultant (SK) with experience in cultural adaptation of lifestyle interventions, and other investigators and staff members with a special interest in minority research. The MI committee adapted the recruitment and intervention materials to be culturally appropriate for African Americans. Cultural appropriateness is defined as the concept of being congruent with the cultural framework of the target population, or presenting no significant disagreement with the cultural value system [13
The MI committee recommended several actions [14
] for enhancing cultural appropriateness in the PREMIER trial, to which each clinical center favorably responded:
- Conduct diversity training for each PREMIER team at each clinical center.
- Hire, train, and support a diverse staff.
- Build a relationship with the African American community at each site to attract participants.
- Communicate study procedures to minority study participants (i.e., remain sensitive to participants' privacy, use a humanistic approach, and treat participants as equals) .
- Give participants and their larger communities feedback in lay terms at the end of the study.
Diversity Training Process
The goal of the diversity training was to increase awareness of the climate of diversity within each clinical center; increase knowledge of the needs, values and attitudes of leadership necessary to address the climate of diversity within each clinical center; enhance skills to improve the work climate and productivity; and enhance recognition of styles of conflict and methods of handling conflict in ways that build respect for the individual. Because these same goals were those of the Louisiana State University (LSU) Agricultural Center, the MI committee selected their veteran Director of Multicultural Diversity (VM), to implement the diversity training for the PREMIER trial.
The cultural diversity trainer utilized the training curriculum prepared for the LSU Agricultural Center employees and clientele to train the then recruitment coordinator (BMK) to conduct diversity workshops and to assist (VM) in the training. The diversity training was tailored to be culturally appropriate sensitivity training for the PREMIER study staff. The 24-hour training was presented over three days. All sessions were non-confrontational, interactive and experiential in nature. A safe environment was provided for open dialogue and discussion through articulating group rules and using small groups. The training covered definitions of such key concepts as culture, diversity, and racism. Exercises encouraged discussion of the effects of prejudicial behavior toward others and enhanced communication skills.
The expected outcome of the diversity training was to develop clinical center leadership necessary to manage the change process related to PREMIER, which reflected the interaction between the majority white culture and minorities in the general population. Therefore, it was important for each PREMIER team to become sensitized on how to interact with participants in ways that were genuinely respectful. It was also expected that the training could develop unity, trust, and cooperation necessary for each clinical center staff member to become a more highly effective team member. A half day of diversity training facilitated by consultant (SK) via teleconferencing initiated the process. All clinical centers staff and personnel involved with PREMIER especially those interacting with participants were included in the training. Each center had at least 3-5 key staff members (at least one or more minorities) along with the principal investigators from each clinical center present for the training. Each new added staff member could then be trained utilizing “train the trainer” approach to continue the process.
PREMIER Pilot Study
To test success of the diversity training and elicit perceptions of attitudes and beliefs about the study administration and procedures from the African American segment, a PREMIER pilot study was conducted. Participants in the two month pilot study were not eligible for the main trial. Three clinical sites; Baltimore, Baton Rouge, and Durham had sufficient numbers of African American participants to conduct focus group evaluations. A total of sixty participants (twenty from each clinical site) with at least half African American participants, participated in one of two focus group sessions.
The PREMIER pilot study was generally found interesting, beneficial, and recommendable. Materials and procedures, while deemed not specifically tailored to minority populations, were not found objectionable. The racial makeup of the intervention staff was also not a particular issue. The mixed racial makeup of the intervention groups was generally well received. At Baltimore and Baton Rouge sites the pilot was found engaging and interesting. Self-monitoring was found somewhat difficult in Baltimore but less problematic in Baton Rouge and Durham, although it was found dull and repetitive by some in the latter site. Finally, there were two strong points that emerged:
- There was a consistent desire for ethnic foods, recipes, and preparation procedures to be included in intervention materials.
- Emphasis on group dynamics for social support both within and between races was considered important and, by implication, underappreciated.
Overall, the PREMIER pilot study was perceived as acceptable. Criticisms made were readily addressed and resolved engendering considerable confidence in the practical utility of the basic Premier trial approach. The favorable pilot study experience provided confidence and credibility for staff who were subsequently involved in efforts to recruit African American participants.
PREMIER clinical centers used a combination of strategies to recruit participants including mass distribution of brochures (mailed letter, flyer included in Val-Pak coupons—a nationwide direct marketing tool various organizations use to advertise their products, goods, and services, or other), mass media (printed article, radio, TV story or ads), word of mouth including prior study participants, email/website, and screening events. Some of these methods were those used previously in recruiting for similar multicenter trials (DASH and DASH- Sodium) [16
]. To enhance recruitment and retention of minority participants, more attention was focused on various cultural variables of the targeted population.
Cultural variables can affect African American persons' perceptions of the feasibility of certain behavior modifications such as health interventions, and affect their perceptions of clinical research [5
]. Thus PREMIER implemented culturally appropriate strategies for recruiting African American participants. These strategies included ethnically appropriate recruitment mailings targeted to zip codes known to be home to many African Americans, community-based screening events in African American neighborhoods, public service announcements on radio stations with primarily African American listening audiences, advertisements in local newspapers strategically placed in the (faith section, sports page for men, food section for women), and those endorsed by prominent African American community leaders. With permission, photographs of community leaders and others were used in advertisements in the Durham and Portland clinical sites to appeal and to attract African American men and women. In addition, the Durham clinical site used a photo in its media efforts () to demonstrate the diversity among its staff.
The recruitment coordinator at each of the four clinical centers was African American, and each was responsible for suggesting and implementing strategies including keeping a log to record how many African Americans were recruited. African American recruiters were hired in part because of their experience or skills in working with the community. Research has suggested in some cases that African Americans may provide an important source of modeling to enable effective interactions with, and to allow ease in addressing participants within their cultural context [15
]. Although the recruitment coordinators were solely responsible for recruitment of participants, all staff including principal investigators were engaged and/or assisted in the process.