A novel recruitment message to increase enrollment into a smoking cessation treatment program: preliminary results from a randomized trial. Recruiting health plan members receiving pharmacotherapy into smoking cessation counseling. Reaching out, inviting back: using Interactive voice response (IVR) technology to recycle relapsed smokers back to Quitline treatment--a randomized controlled trial. Effectiveness of impersonal versus interpersonal methods to recruit employees into a worksite quit smoking program. Using a low-cost, prize-drawing incentive to improve recruitment rate at a work-site smoking cessation clinic. Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support. Do messages of scarcity increase trial recruitment? Impact of a brief motivational smoking cessation intervention the Get PHIT randomized controlled trial. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. The SUCCESS project: the effect of program format and incentives on participation and cessation in worksite smoking cessation programs. Recruitment in a primary care trial on smoking cessation. Successful recruitment of minorities into clinical trials: The Kick It at Swope project. Interest in an online smoking cessation program and effective recruitment strategies: results from Project Quit. A randomized, controlled trial of financial incentives for smoking cessation.
Most smokers do not utilize approved interventions for nicotine dependence, reducing the probability of cessation. Smoking cessation programs typically use recruitment messages emphasizing the health threats of smoking. Augmenting this threat message by describing the genetic aspects of nicotine addiction may enhance enrollment into a cessation program. During telephone recruitment, 125 treatment-seeking smokers were randomized to receive by phone either a standard threat message or a threat plus genetic prime message and were offered open-label varenicline and counseling. There was a greater rate of enrollment into the cessation program for the threat plus genetic prime participants (51.7%) versus the threat-only participants (37.7%; p = .03). Smokers who self-identified from racial/ethnic minority groups were less likely to enroll in the cessation program (p = .01) versus smokers who self-identified as Caucasian. These preliminary data suggest that a simple, affordable, and transportable communication approach enhances enrollment of smokers into a smoking cessation program. A larger clinical trial to evaluate a genetic prime message for improving recruitment into smoking cessation programs is warranted. Smokers receiving pharmacotherapy and individualized smoking cessation counseling through telephone quitlines have been found to have higher quit rates than smokers receiving pharmacotherapy alone. Health plans are often positioned to encourage their members to use quitline services in addition to pharmacotherapy.
                To determine if healthcare members who were receiving pharmacotherapy increased their participation in smoking quitline services after receiving proactive telephone calls or postcards.
                Randomized controlled trial.
                Health plan members filing pharmacotherapy claims were identified weekly from health plan pharmacy claims data and randomized to 1 of the following 3 conditions: control, recruitment postcard, or recruitment telephone call by a nurse quitline counselor. Enrollment of study members into the quitline program was tracked for 1 month after randomization.
                During 5 months, 625 individuals were identified for participation in the study, with the following enrollment into the program: 0% to the control group, 1.3% to the postcard group, and 20.6% to the telephone call group (P < .001 for significance by group). Although costs for the telephone intervention were the most expensive, it was also the most cost effective, given its success in enrolling members into the program.
                Proactive telephone calling by smoking cessation nurse counselors to smokers receiving pharmacotherapy may be an effective method of enrolling smokers into a cessation quitline. Health plans should consider proactive telephone recruitment to improve use of quitline services. Tobacco dependence is a chronic, relapsing condition that typically requires multiple quit attempts and extended treatment. When offered the opportunity, relapsed smokers are interested in recycling back into treatment for a new, assisted quit attempt. This manuscript presents the results of a randomized controlled trial testing the efficacy of interactive voice response (IVR) in recycling low income smokers who had previously used quitline (QL) support back to QL support for a new quit attempt.
                A sample of 2985 previous QL callers were randomized to either receive IVR screening for current smoking (control group) or IVR screening plus an IVR intervention. The IVR intervention consists of automated questions to identify and address barriers to re-cycling in QL support, followed by an offer to be transferred to the QL and reinitiate treatment. Re-enrollment in QL services for both groups was documented.
                The IVR system successfully reached 715 (23.9%) former QL participants. Of those, 27% (194/715) reported to the IVR system that they had quit smoking and were therefore excluded from the study and analysis. The trial's final sample was composed of 521 current smokers. The re-enrollment rate was 3.3% for the control group and 28.2% for the intervention group (p < .001). Logistic regression results indicated an 11.2 times higher odds for re-enrollment of the intervention group than the control group (p < .001). Results did not vary by gender, race, ethnicity, or level of education, however recycled smokers were older (Mean = 45.2; SD = 11.7) than smokers who declined a new treatment cycle (Mean = 41.8; SD = 13.2); (p = 0.013). The main barriers reported for not engaging in a new treatment cycle were low self-efficacy and lack of interest in quitting. After delivering IVR messages targeting these reported barriers, 32% of the smokers reporting low self-efficacy and 4.8% of those reporting lack of interest in quitting re-engaged in a new QL treatment cycle.
                Proactive IVR outreach is a promising tool to engage low income, relapsed smokers back into a new cycle of treatment. Integration of IVR intervention for recycling smokers with previous QL treatment has the potential to decrease tobacco-related disparities.
                ClinicalTrials.gov Identifier: NCT01260597. One of the first salient issues a worksite quit smoking program must face is how to motivate employees to enroll and participate. The purpose of this study was to determine the effectiveness of impersonal versus interpersonal recruitment strategies used by an ongoing worksite quit smoking program. One hundred and nineteen smokers who stated on a questionnaire that they would be either "strongly yes" or "yes" interested in participating in a quit smoking program were randomized into two groups. One group was sent letters by employee mail from the director of the quit smoking program. This letter briefly described the program and invited employees to participate. The other group received a personal phone call from the staff health educator inviting them to participate. Results indicate that of the 46 individuals randomly assigned to Group 1 who were sent letters, none responded to the invitation; while 37 of the 44 employees who received a personal phone call, 19 scheduled an appointment, 7 kept their appointments. These results indicate the possible increased effectiveness of an impersonal versus interpersonal communications in recruiting full-time smoking employees. A major obstacle in promoting smoking cessation programs through work sites is recruiting adequate numbers of smokers. We used a quasi-experimental design to evaluate the effect of a low-cost incentive (a prize drawing) for attracting participants to a smoking cessation clinic offered at multiple work sites. Sixty-eight automobile dealerships were randomized to either a "prize" or control group. Smokers employed at work sites in the prize group were offered a chance to win a dinner for two for participating in a smoking cessation clinic. In November 1986, a questionnaire assessing tobacco use habits was sent to 3432 employees of the 68 work sites. A cohort of 844 smokers was identified from a total of 1986 employees who returned surveys. All smokers received registration materials to participate, free of charge, in one of three smoking cessation programs held in June 1987. The overall employee participation rate in the smoking cessation program was 6.6% (n = 56) with an overall work-site participation rate of 37.3% (n = 25). The rate was nearly identical in the "prize" and control groups (employee rate: 6.3% versus 6.7%; work-site rate: 39.4% versus 35.3%, respectively). Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial.
                To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants.
                Single blind controlled trials with allocation concealment. Interventions: Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures.
                Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2).
                There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic.
                Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com. Psychological theory suggests that participants may be more likely to volunteer to join a clinical trial if they perceive places in the trial are a scarce commodity.
                We conducted a single blind, randomized controlled trial to test recruitment strategies within the larger txt2stop smoking cessation trial. 1862 people who were eligible for the txt2stop trial but had not yet consented to join were randomized to receive either A) a reminder about the txt2stop trial plus a message that there were only 300 places left, or B) a reminder about the trial only. The outcome was the participant's consent to join the txt2stop trial 3days after messages were sent.
                Of 895 participants randomized to the intervention group, 90 (10.1%) had consented to join the txt2stop trial. Of the 967 participants randomized to the control group, 67 (6.9%) had consented to join the txt2stop trial (OR=1.50, 95% CI 1.07-2.12).
                Scarcity messages were an effective way to increase recruitment into the txt2stop trial and could be relevant to other trials.
                Communicating scarcity is an effective way to increase trial recruitment.
                Copyright © 2010 Elsevier Inc. All rights reserved. Few studies have rigorously evaluated whether providing biologically based health-risk feedback is more effective than standard interventions in increasing smokers' motivation to quit and their long-term abstinence.
                An RCT was conducted from 2005 to 2008. Data were analyzed in 2008.
                Smokers (N=536) were recruited from the community, regardless of their interest in quitting smoking.
                Smokers either received brief ( approximately 20 minutes), personally tailored counseling sessions based on their lung functioning, carbon monoxide (CO) exposure, and smoking-related health conditions, or they received generic smoking-risk information and personalized counseling about their diet, BMI, and physical activity. All were advised to quit smoking and were offered access to a free phone-counseling program.
                Treatment utilization and abstinence at 6 and 12 months post-intervention.
                Participants who received the experimental treatment demonstrated no greater motivation to quit, use of treatment services, or abstinence compared to controls at either follow-up assessment. In fact, controls reported greater motivation to quit at 12 months (M 3.42 vs 3.20, p=0.03), greater use of pharmacotherapy at 6 months (37.8% vs 28.0%, p=0.02), and greater 30-day point prevalent abstinence at 6 months, after controlling for relevant covariates (10.8% vs 6.4%, adjusted p=0.04).
                The present study found no support for adding a personalized health-risk assessment emphasizing lung health and CO exposure to generic cessation advice and counseling for community-based smokers not otherwise seeking treatment.
                NCT00169260. Recruiting pregnant smokers into smoking cessation intervention trials is challenging. Changes in health care systems offer new opportunities to overcome many of the obstacles encountered by researchers attempting to address the significant harm from maternal smoking. Investigators could facilitate smoking cessation study recruitment by collaborating with health care systems that systematically collect patient smoking status and record it in a centralized, retrievable fashion. This paper reports the results of utilizing this novel approach and compares it with a typical decentralized practice-based recruitment strategy.
                The study was conducted at Massachusetts General Hospital, in Boston, Massachusetts, from 2000 to 2005. Four hundred forty-two pregnant smokers were recruited for a randomized controlled trial of telephone-delivered smoking counseling from two sources: a network-model managed care health plan and community-based practices (CBP). At the health plan, study recruitment was built on an existing system that permitted pregnant smokers to be identified centrally. At the CBPs, identification and referral systems had to be developed at each practice specifically for the study. The two strategies were compared on the efficiency of recruitment, characteristics of enrollees, and study outcome and process measures.
                The health plan strategy generated referrals nearly twice as fast as the CBP strategy (30.4 vs. 17.0 per month), but because referrals were not timely, a large proportion of women from the plan were too advanced in pregnancy to be eligible to enroll in the study. As a result, the two strategies yielded a comparable enrollment rate. Participants from the health plan were older, better educated, less racially diverse, more likely to be living with the baby's father, and less likely to have smokers in their environment. These differences were largely explained by the socioeconomic diversity of women recruited from the CBPs. Smoking cessation outcomes did not differ by recruitment source.
                A recruitment strategy using a health plan's centralized system was more efficient than a practice-based recruitment strategy at identifying potential study participants, but less efficient at generating study participants from the referrals received. Importantly, participants recruited by the two strategies differed by socioeconomic, but not cessation-related, characteristics. To date, recruiting pregnant smokers into intervention studies remains resource intensive and time consuming. Participant identification and recruitment will be greatly enhanced by health system innovations such as implementation of electronic medical records. This study examined the effect of program format and incentives on participation and cessation in worksite smoking cessation programs.
                Twenty-four worksites were randomized to 6 conditions that differed in cessation program format and the use of incentives. Programs were offered for 18 months in each worksite. A total of 2402 cigarette smokers identified at baseline were surveyed 12 and 24 months later to assess participation in programs and cessation.
                A total of 407 (16.9%) of the smoker cohort registered for programs; on the 12- and 24-month surveys, 15.4% and 19.4% of the cohort, respectively, reported that they had not smoked in the previous 7 days. Registration for programs in incentive sites was almost double that of no-incentive sites (22.4% vs 11.9%), but increased registration did not translate into significantly greater cessation rates. Program type did not affect registration or cessation rates.
                Although incentives increase rates of registration in worksite smoking cessation programs, they do not appear to increase cessation rates. Phone counseling seems to be at least as effective as group programs for promoting smoking cessation in worksites. The purpose of this study was to describe and compare the rates of recruitment during a randomized clinical trial on smoking cessation in two primary care practices. One site was a five-physician private family practice setting with about 15,000 patients. During 34 days, 576 patients were screened, of whom 22% were smokers. Among the smokers screened, 54% consented, 33% refused consent, and 13% were called in too early to consent. The other site was a six-physician academic medical practice with about 16,000 patients. During 53 days, 1,692 subjects were screened, of whom 16.2% were smokers. Among the smokers, 19% consented, 81% refused consent, and none were called in early. The enrollment of smokers was 3.3 times greater in the private practice than the academic practice. At the first site, study personnel screened 26.6 subjects per day, whereas the practice receptionist screened only 13.4 subjects per day (P less than .01). A randomized trial of having subjects read the informed consent versus having study personnel read it to them showed no differences in recruitment. The data suggest that private practices may have greater potential for subject recruitment than academic sites, that using study personnel improves recruitment, and that having study personnel actively involved in informed consent does not improve recruitment. Ethnic minorities are often underrepresented in clinical trials, and their recruitment can challenge researchers. Developing and communicating effective and efficient recruitment strategies may help researchers enroll more minorities into research studies. Kick It at Swope was a double-blind, randomized trial that evaluated bupropion for smoking cessation among 600 adult African Americans who smoked 10 or more cigarettes a day. Proactive recruitment strategies (in-person appeals by study staff and health care providers) and reactive recruitment strategies (disseminating information that asked people to call a study hotline) were implemented sequentially in an additive fashion over 16 months. Resulting patterns of recruitment are described and the two phases are compared based on their relative effectiveness, efficiency, and cost. More enrollees were recruited in the reactive phase (n=534) than in the proactive phase (n=66). Those recruited in the reactive phase were more likely to be eligible (OR=4.8) and more likely to be enrolled (OR=4.2) than those recruited in the proactive phase. Participants recruited in the reactive phase reported significantly higher levels of education and income, better health, and significantly lower indicators of depression and life hassles, compared with those recruited in the proactive phase. The reactive recruitment phase was less expensive than the proactive recruitment phase (22 US Dollars/enrollee vs. 159 US Dollars/enrollee). Reactive recruitment strategies added to multiple proactive clinic-based recruitment strategies were more effective, more efficient, and less costly than proactive recruitment alone. Close monitoring combined with the use of multiple recruitment methods and flexible recruitment plans can lead to successful, efficient, and low-cost recruitment of minorities into clinical trials. The Internet is a promising venue for delivering smoking cessation treatment, either as a stand-alone program or as an adjunct to pharmacotherapy. However, there is little data to indicate what percent of smokers are interested in receiving online smoking cessation services or how best to recruit smokers to Internet-based programs.
                Using a defined recruitment sample, this study aimed to identify the percentage of smokers who expressed interest in or enrolled in Project Quit, a tailored, online, cognitive-behavioral support program offered with adjunctive nicotine replacement therapy patches. In addition, we examined the effectiveness of several individual-level versus population-level recruitment strategies.
                Members from two large health care organizations in the United States were invited to participate in Project Quit. Recruitment efforts included proactive invitation letters mailed to 34533 likely smokers and reactive population-level study advertisements targeted to all health plan members (> 560000 adults, including an estimated 98000 smokers across both health care organizations).
                An estimated 1.6% and 2.5% of adult smokers from each health care organization enrolled in Project Quit. Among likely smokers who received proactive study invitations, 7% visited the Project Quit website (n = 2260) and 4% (n = 1273) were eligible and enrolled. Response rates were similar across sites, despite using different sources to assemble the invitation mailing list. Proactive individual-level recruitment was more effective than other forms of recruitment, accounting for 69% of website visitors and 68% of enrollees.
                Smokers were interested in receiving online smoking cessation support, even though they had access to other forms of treatment through their health insurance. Uptake rates for this program were comparable to those seen when smokers are advised to quit and are referred to other forms of smoking cessation treatment. In this sample, proactive mailings were the best method for recruiting smokers to Project Quit. Smoking is the leading preventable cause of premature death in the United States. Previous studies of financial incentives for smoking cessation in work settings have not shown that such incentives have significant effects on cessation rates, but these studies have had limited power, and the incentives used may have been insufficient.
                We randomly assigned 878 employees of a multinational company based in the United States to receive information about smoking-cessation programs (442 employees) or to receive information about programs plus financial incentives (436 employees). The financial incentives were $100 for completion of a smoking-cessation program, $250 for cessation of smoking within 6 months after study enrollment, as confirmed by a biochemical test, and $400 for abstinence for an additional 6 months after the initial cessation, as confirmed by a biochemical test. Individual participants were stratified according to work site, heavy or nonheavy smoking, and income. The primary end point was smoking cessation 9 or 12 months after enrollment, depending on whether initial cessation was reported at 3 or 6 months. Secondary end points were smoking cessation within the first 6 months after enrollment and rates of participation in and completion of smoking-cessation programs.
                The incentive group had significantly higher rates of smoking cessation than did the information-only group 9 or 12 months after enrollment (14.7% vs. 5.0%, P<0.001) and 15 or 18 months after enrollment (9.4% vs. 3.6%, P<0.001). Incentive-group participants also had significantly higher rates of enrollment in a smoking-cessation program (15.4% vs. 5.4%, P<0.001), completion of a smoking-cessation program (10.8% vs. 2.5%, P<0.001), and smoking cessation within the first 6 months after enrollment (20.9% vs. 11.8%, P<0.001).
                In this study of employees of one large company, financial incentives for smoking cessation significantly increased the rates of smoking cessation. (ClinicalTrials.gov number, NCT00128375.)
                2009 Massachusetts Medical Society
The substantial heterogeneity across the included studies restricts our ability to draw firm conclusions about the effectiveness of different recruitment strategies in relation to recruitment of participants into smoking cessation programmes or levels of smoking cessation. The limited evidence, however, suggests that the following elements may improve the recruitment of smokers into cessation programmes: personal, tailored interventions; recruitment methods that are proactive in nature; and more intensive recruitment strategies (i.e., those strategies that require increased contact with potential participants).