Mass Mailing and Staff Experience in a Total Recruitment Program for a Clinical Trial

Cosgrove, Nora M.; Borhani, Nemat O.; Bailey, Geri; Borhani, Patty; Levin, Julie; Hoffmeier, Mary; Krieger, Susan; Lovato, Laura; Petrovitch, Helen; Vogt, Thomas; Wilson, Alan C.; Breeson, Vincent; Probstfield, Jeffrey L.

doi:10.1016/s0197-2456(98)00055-5

Cited by 33 publications

(24 citation statements)

References 23 publications

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“…The recruitment yield (enrolled/total identified) of 5.4% achieved in this study is consistent with other published studies involving large civilian multi-site studies which have reported yields ranging from 0.5% [23], 1.1% [24], 2.6% [25], 5.5% [26], to 13% [27]. However, none of the aforementioned studies involved veterans or used population-based sampling methods and therefore generalization to the current study is not straightforward.…”

Section: Discussionsupporting

confidence: 91%

Challenges to be overcome using population-based sampling methods to recruit veterans for a study of post-traumatic stress disorder and traumatic brain injury

Bayley

Kong

Helmer

et al. 2014

BMC Med Res Methodol

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BackgroundMany investigators are interested in recruiting veterans from recent conflicts in Afghanistan and Iraq with Traumatic Brain Injury (TBI) and/or Post Traumatic Stress Disorder (PTSD). Researchers pursuing such studies may experience problems in recruiting sufficient numbers unless effective strategies are used. Currently, there is very little information on recruitment strategies for individuals with TBI and/or PTSD. It is known that groups of patients with medical conditions may be less likely to volunteer for clinical research. This study investigated the feasibility of recruiting veterans returning from recent military conflicts— Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) - using a population-based sampling method.MethodsIndividuals were sampled from a previous epidemiological study. Three study sites focused on recruiting survey respondents (n = 445) who lived within a 60 mile radius of one of the sites.ResultsOverall, the successful recruitment of veterans using a population-based sampling method was dependent on the ability to contact potential participants following mass mailing. Study enrollment of participants with probable TBI and/or PTSD had a recruitment yield (enrolled/total identified) of 5.4%. We were able to contact 146 individuals, representing a contact rate of 33%. Sixty-six of the individuals contacted were screened. The major reasons for not screening included a stated lack of interest in the study (n = 37), a failure to answer screening calls after initial contact (n = 30), and an unwillingness or inability to travel to a study site (n = 10). Based on the phone screening, 36 veterans were eligible for the study. Twenty-four veterans were enrolled, (recruitment yield = 5.4%) and twelve were not enrolled for a variety of reasons.ConclusionsOur experience with a population-based sampling method for recruitment of recent combat veterans illustrates the challenges encountered, particularly contacting and screening potential participants. The screening and enrollment data will help guide recruitment for future studies using population-based methods.

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Section: Discussionsupporting

confidence: 91%

Challenges to be overcome using population-based sampling methods to recruit veterans for a study of post-traumatic stress disorder and traumatic brain injury

Bayley

Kong

Helmer

et al. 2014

BMC Med Res Methodol

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“…Of the 31,407 subjects identified by this survey of 21 sites, 4,300 (13.7%) were enrolled, and 386 (1.2%) were randomized into the study. Similar low yields in multi-site studies have been described [13][14][15][16][17][18][19]. The unique veteran population in our study, strict inclusion [4,20].…”

Section: Discussionsupporting

confidence: 84%

“…In this study, the Gulf War Veteran Registry was the most reliable, logical, and, from a confidentiality viewpoint, appropriate source for reaching potential study participants. From this source, 78% of the GWV contacted could be reached by mail or telephone, methods used by others [11,[13][14][15]21]. In a different patient population, where the study goal was smoking cessation, paid news advertisements were found to be superior to other recruitment methods [22].…”

Section: Discussionmentioning

confidence: 99%

Mass mailing and telephone contact were effective in recruiting veterans into an antibiotic treatment randomized clinical trial

Resio

Baltch

Smith

2004

Journal of Clinical Epidemiology

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“…In cardiovascular trials with hard clinical endpoints such as death or hospitalization for stroke or myocardial infarction, the length of time for following participants is vital to having enough statistical power to accurately answer the research question. 2,3 …”

Section: Introductionmentioning

confidence: 99%

“…Prior large hypertension trials – Systolic Hypertension in the Elderly Program, 3,6 Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack, 7,8 and Action to Control Cardiovascular Risk in Diabetes 9 – demonstrated that multiple recruitment strategies are required for successful enrollment. These trials all took longer to recruit than originally anticipated, ranging from three months, approximately 10 months, to 1.5 years longer than planned.…”

Section: Introductionmentioning

confidence: 99%

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial

et al. 2016

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Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal <120 mm Hg) compared to standard control (systolic blood pressure goal <140 mm Hg) on cardiovascular events using commonly prescribed antihypertensive medications and lifestyle modification. Objective To describe the recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those age ≥ 75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates and trial power in mind. As overall recruitment improved, a greater focus on subgroup recruitment was implemented. Conclusion SPRINT met its overall projected recruitment goal by using diverse, locally adapted enrollment strategies to specifically target persons with cardiovascular disease, chronic kidney disease, ≥ 75 year old, women, and minority subgroups. The trial exceeded its recruitment goal for minorities but found it a challenge to meet the competing demands of the targeted goals for recruiting into the remaining four subgroups. Important lessons include the imperative to monitor the recruitment process carefully, decide early to add new clinics or modify inclusion and exclusion criteria if recruitment lags, and consider limiting enrollment to subgroups only. We found benefit in using multiple recruitment sources simultaneously...

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Mass Mailing and Staff Experience in a Total Recruitment Program for a Clinical Trial

Cited by 33 publications

References 23 publications

Challenges to be overcome using population-based sampling methods to recruit veterans for a study of post-traumatic stress disorder and traumatic brain injury

Challenges to be overcome using population-based sampling methods to recruit veterans for a study of post-traumatic stress disorder and traumatic brain injury

Mass mailing and telephone contact were effective in recruiting veterans into an antibiotic treatment randomized clinical trial

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial

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