BACKGROUND: Special challenges are encountered when clinical trial recruitment targets a physician practice-based population, as opposed to recruiting from the community. Since most published information about recruitment has focused on the latter group, summation of successful primary-care-based recruitment strategies could prove useful for future trials recruiting from this population. METHODS: The Activity Counseling Trial (ACT) is a multicenter, randomized clinical trial that evaluated approaches to primary care-based interventions to increase physical activity in sedentary adults 35-75 years of age. Fifty-four clinicians from eight practices recruited 874 participants from three U.S. sites. Recruitment challenges that related, in great part, to the primary care setting included: (1) focusing on patients from ACT physician practices who had regularly scheduled or intend-to-schedule appointments within the next year; (2) placing trial staff in the clinical offices for recruitment purposes; and (3) placing trial interventionists in the physicians' offices. Other challenges were related to recruitment of minorities and men. RESULTS: Patient mailing yielded 43.4% of all randomized participants, followed by office-based questionnaires (32.5%) and direct telephone contact (21.6%). Based on a retrospective cost-effective analysis (indirect costs excluded), the self-administered office-based questionnaire was the least costly strategy for one site ($14/randomized participant), followed by patient mailing at another site ($58). The direct telephone contact method utilized at one site serving primarily a minority population yielded a per randomized participant cost of $80. CONCLUSIONS: Recruitment of clinical trial participants from practice-based populations requires modification of the strategies used to recruit from the community. Multiple strategies should be employed, followed closely for their respective yields, and adapted as needed.
RCT Entities:
BACKGROUND: Special challenges are encountered when clinical trial recruitment targets a physician practice-based population, as opposed to recruiting from the community. Since most published information about recruitment has focused on the latter group, summation of successful primary-care-based recruitment strategies could prove useful for future trials recruiting from this population. METHODS: The Activity Counseling Trial (ACT) is a multicenter, randomized clinical trial that evaluated approaches to primary care-based interventions to increase physical activity in sedentary adults 35-75 years of age. Fifty-four clinicians from eight practices recruited 874 participants from three U.S. sites. Recruitment challenges that related, in great part, to the primary care setting included: (1) focusing on patients from ACT physician practices who had regularly scheduled or intend-to-schedule appointments within the next year; (2) placing trial staff in the clinical offices for recruitment purposes; and (3) placing trial interventionists in the physicians' offices. Other challenges were related to recruitment of minorities and men. RESULTS:Patient mailing yielded 43.4% of all randomized participants, followed by office-based questionnaires (32.5%) and direct telephone contact (21.6%). Based on a retrospective cost-effective analysis (indirect costs excluded), the self-administered office-based questionnaire was the least costly strategy for one site ($14/randomized participant), followed by patient mailing at another site ($58). The direct telephone contact method utilized at one site serving primarily a minority population yielded a per randomized participant cost of $80. CONCLUSIONS: Recruitment of clinical trial participants from practice-based populations requires modification of the strategies used to recruit from the community. Multiple strategies should be employed, followed closely for their respective yields, and adapted as needed.
Authors: Georgio Mosis; Albert E Vlug; Mees Mosseveld; Jeanne P Dieleman; Bruno C Stricker; Johan van der Lei; Miriam C J M Sturkenboom Journal: J Am Med Inform Assoc Date: 2005-07-27 Impact factor: 4.497
Authors: Christina B Felsen; Eric K Shaw; Jeanne M Ferrante; Lorraine J Lacroix; Benjamin F Crabtree Journal: J Am Board Fam Med Date: 2010 Jul-Aug Impact factor: 2.657
Authors: Georita M Frierson; David M Williams; Shira Dunsiger; Beth A Lewis; Jessica A Whiteley; Anna E Albrecht; John M Jakicic; Santina M Horowitz; Bess H Marcus Journal: Clin Trials Date: 2008 Impact factor: 2.486
Authors: Sarah L Goff; Yara Youssef; Penelope S Pekow; Katharine O White; Haley Guhn-Knight; Tara Lagu; Kathleen M Mazor; Peter K Lindenauer Journal: J Racial Ethn Health Disparities Date: 2016-04-11