A Formative Evaluation of Two FASD Prevention Communication Strategies.

AIMS: To evaluate the feasibility, acceptability and effectiveness of placing FASD prevention messages in the women's restrooms of establishments serving alcohol in Alaska and the Yukon, regions with high rates of FASD. METHODS: Our team placed an FASD educational poster, and posters affixed to a pregnancy test dispenser, in women's restrooms of bars and restaurants. We compared drinking behaviors and knowledge and beliefs about FASD among participants at baseline and at follow-up. RESULTS: Respondents consisted of 2132 women who completed a baseline survey and 1182 women who completed both a baseline and a follow-up survey. Women in both groups showed improvement in knowledge of FASD; the dispenser group scored higher than participants in the poster group on the FASD Health Belief questions at both baseline and follow-up. Forty-three women learned they were pregnant from our pregnancy tests and alcohol consumption among pregnant women was lower at follow-up than at baseline. CONCLUSIONS: FASD prevention messages, particularly paired with pregnancy test dispensers, in the women's restrooms of establishments that serve alcohol can effectively promote informed alcohol consumption decisions among women who are, or may become, pregnant. SHORT SUMMARY: In this FASD prevention feasibility study, we found that FASD prevention messages, particularly paired with pregnancy test dispensers, placed in the women's restrooms of establishments that serve alcohol can effectively promote informed alcohol consumption decisions among women who are, or may become, pregnant.

A Process Evaluation of the WV Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Dissemination Initiative: Assessing the Fidelity and Impact of Delivery for State-Wide, Home-Based Healthy Start Services.

Objectives Process evaluation data are essential to document the fidelity of program implementation by clinical staff and confirm patient behavior change. This report presents a process evaluation model applied to the Smoking Cessation and Reduction in Pregnancy Treatment Dissemination Initiative for the statewide, home-based West Virginia Right From The Start Project. Methods Trained RFTS Designated Care Coordinators, nurses and social workers, of 50+ primary care agencies in all 55 counties, delivered SCRIPT to Medicaid patients who smoked. Results The process evaluation defined the level of DCC delivery of seven core SCRIPT procedures to produce a Program Implementation Index: a summary performance metric. A SCRIPT PII > 0.80 was established as the RFTS adoption standard. The PII increased from 0.53 in 2004 to 0.65 in 2006-2007 to 0.77 in 2009-2010. Although the PII > 0.80 was not achieved, exposure rates were increased for all seven SCRIPT procedures. Agency and DCC turnover, a transient patient population, and recession of 2008-2010 were barriers to achieving the adoption metric and implementation of an experimental design. A quasi-experimental Stratified, Matched Comparison (C) Group Design was selected to evaluate behavioral impact differences between a RFTS-Comparison (C) Group from 2006 to 2007 and the RFTS-SCRIPT E Group from 2009 to 2010. Impact analyses of the DCC delivery of the SCRIPT Program with higher fidelity documented a statistically significant increase in the cessation rate from 4.6 % and significant reduction rate from 6.9 % for the (C) Group in 2006-2007 to 13.9 % and 11.22 % respectively for the E Group in 2009-2010. Conclusion The PEM can assist statewide, home-based prenatal care programs to improve the quality of delivery and evaluate counseling programs.

A randomized trial of Text2Quit: a text messaging program for smoking cessation.

BACKGROUND: Text messaging programs on mobile phones have shown some promise in helping people quit smoking. Text2Quit is an automated, personalized, interactive mobile health program that sends text messages to offer advice, support, and reminders about quitting smoking. PURPOSE: To evaluate the effect of Text2Quit on biochemically confirmed repeated point prevalence abstinence in the context of an RCT conducted in the U.S. METHODS: Participants (n=503) were recruited on the Internet and randomized to receive Text2Quit or self-help material. Between 2011 and 2013, participants were surveyed at baseline and at 1, 3, and 6 months post-enrollment to assess smoking status. Saliva was collected from participants who reported not smoking in the past 7 days at the 6-month follow-up. An intent to treat analysis was used, and those lost to follow-up were categorized as smokers. All analyses were completed in 2013. RESULTS: Biochemically confirmed repeated point prevalence abstinence favored the intervention group, with 11.1% abstinent compared to 5.0% of the control group (relative risk=2.22, 95% CI=1.16, 4.26, p<0.05). Similarly, self-reported repeated point prevalence abstinence was higher in the intervention group (19.9%) than in the control group (10.0%) (p<0.01). Effects were found to be uniform across the analyzed demographic subgroups, although suggestive of a larger effect for non-whites than whites. CONCLUSIONS: These results provide initial support for the relative efficacy of the Text2Quit program.

Effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) dissemination project: a science to prenatal care practice partnership.

This study evaluated the effectiveness of the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Program selected by the West Virginia-Right From The Start Project for state-wide dissemination. A process evaluation documented the fidelity of SCRIPT delivery by Designated Care Coordinators (DCC), licensed nurses and social workers who provide home-based case management to Medicaid-eligible clients in all 55 counties. We implemented a quasi-experimental, non-randomized, matched Comparison (C) Group design. The SCRIPT Experimental E Group (N = 259) were all clients in 2009-2010 that wanted to quit, provided a screening carbon monoxide (CO), and received a SCRIPT home visit. The (C) Group was derived from all clients in 2006-2007 who had the same CO assessments as E Group clients and reported receiving cessation counseling. We stratified the baseline CO of E Group clients into 10 strata, and randomly selected the same number of (C) Group clients (N = 259) from each matched strata to evaluate the effectiveness of the SCRIPT Program. There were no significant baseline differences in the E and (C) Group. A Process Evaluation documented a significant increase in the fidelity of DCC delivery of SCRIPT Program procedures: from 63 % in 2006 to 74 % in 2010. Significant increases were documented in the E Group cessation rate (+9.3 %) and significant reduction rate (+4.5 %), a ≥50 % reduction from a baseline CO. Perinatal health case management staff can deliver the SCRIPT Program, and Medicaid-supported clients can change smoking behavior, even very late in pregnancy. When multiple biases were analyzed, we concluded the SCRIPT Dissemination Project was the most plausible reason for the significant changes in behavior.

The Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Adoption Scale: evaluating the diffusion of a tobacco treatment innovation to a statewide prenatal care program and providers.

When a new patient education program is being considered for adoption by a public health agency, it is essential to determine provider perceptions of its acceptability for routine use. In 2007, the West Virginia Bureau of Public Health Perinatal Program, Right From The Start (RFTS), decided to adopt the Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) Program. RFTS is a statewide perinatal home visitation initiative delivered by designated care coordinators (DCCs). The authors developed the SCRIPT Adoption Scale (SAS) in the absence of a valid instrument to assess the perceived attributes of a tobacco treatment innovation among the RFTS DCC population. They evaluated the validity of the five constructs of the Rogers' Diffusion of Innovations model in an organization (relative advantage, compatibility, complexity, observability, and trialability) to predict SCRIPT use. After reviewing the literature and developing draft SAS forms, 2 expert panel reviews established the face and content validity of a 43-item SAS. It was administered to 90% (85/90) of the RFTS DCC population. Psychometric analyses confirmed the validity and reliability of a 28-item scale. All 28 items had factor loadings greater than 0.40 (range = 0.43-0.81). All SAS subscales were strongly correlated, r = 0.51 to 0.97, supporting the convergent validity of a 5-factor SAS. There was a significant association between the DCC SAS score and DCC SCRIPT Program Implementation Index supporting the SAS convergent (construct) validity (r = 0.38). The SAS internal consistencyr = 0.93 and stabilityr = 0.76. Although 2 specific subscales need to be improved, the SAS can be adapted by prenatal care programs to measure the attributes of adoption of new, evidence-based patient education and counseling methods.

A friendships and dating program for adults with intellectual and developmental disabilities: a formative evaluation.

Meaningful relationships with others are often elusive for people with intellectual and developmental disabilities, but no less desired for their full inclusion and participation in society. It is well documented that people with disabilities are victims of interpersonal violence at higher rates than peers without disabilities. This article presents a formative evaluation of the Friendships and Dating Program (FDP). The FDP was designed to teach the social skills needed to develop healthy, meaningful relationships and to prevent violence in dating and partnered relationships. Thirty-one adults were recruited by 5 community agencies in Alaska to participate. The results showed the size of the participants' social networks increased and the number of incidents of interpersonal violence was reduced for participants who completed the FDP, and outcomes were maintained 10 weeks later.

A randomized clinical trial of trans-dermal nicotine replacement in pregnant African-American smokers.

We compared acceptability, adherence and efficacy of trans-dermal nicotine patches and cognitive behavioral therapy (Group 1) to cognitive behavioral therapy alone (Group 2) in minority pregnant smokers. This is a randomized controlled trial. 52 women were recruited during pregnancy with a mean gestational age 18.5 ± 5.0 weeks and followed through delivery. Randomization was by site and initial cotinine levels. Interventionists and interviewers were blinded to group assignment. Two different nicotine replacement therapy dosing regiments were administered according to the baseline salivary cotinine level. A process evaluation model summarized patient adherence. The main outcome measure was self-report of cessation since last visit, confirmed by exhaled carbon monoxide. Analyses of categorical and continuous measures were conducted as well as linear trend tests of salivary cotinine levels. Women lost to follow-up were considered treatment failures. Participants were on average 27.5 ± 5.4 years old, 81 % were single, 69 % unemployed and 96 % were Medicaid eligible. A process evaluation indicated patients in both groups were adherent to scheduled program procedures through Visit 4, but not for Visits 5 and 6. Confirmed quit rates were: at visit 3, 23 (Group 1) and 0 % (Group 2) (p = 0.02); at visits 4 and 5, no difference; at visit 6, 19 (Group 1) and 0 % (Group 2) (p = 0.05). Group 1 delivered infants with a mean gestational age of 39.4 weeks versus 38.4 weeks in Group 2 (p = 0.02). 73 % (52/71) of the eligible smokers agreed to participate and 65 % (17/26) of Group 1 completed the protocol (i.e. attended 6 visits). A comparison of Group 1 and 2 quit rates confirmed a non-significant difference.

Text2Quit: results from a pilot test of a personalized, interactive mobile health smoking cessation program.

Text messaging programs on mobile phones have shown some promise in helping people quit smoking. Text2Quit is an automated, personalized, and interactive mobile health program that sends text messages and e-mails timed around a participant's quit date over the course of 3 months. The text messages include pre- and post-quit educational messages, peer ex-smoker messages, medication reminders and relapse messages, and multiple opportunities for interaction. Study participants were university students (N = 23) enrolled in the Text2Quit program. Participants were surveyed at baseline and at 2 and 4 weeks after enrollment. The majority of participants agreed that they liked the program at 2 and 4 weeks after enrollment (90.5% and 82.3%, respectively). Support for text messages was found to be moderate and higher than that of the e-mail and web components. Of participants, 75% reported reading most or all of the texts. On average, users made 11.8 responses to the texts over a 4-week period, although responses declined after the quit date. The interactive feature for tracking cigarettes was the most used interactive feature, followed by the craving trivia game. This pilot test provides some support for the Text2Quit program. A future iteration of the program will include additional tracking features in both the pre-quit and post-quit protocols and an easier entry into the not-quit protocol. Future studies are recommended that identify the value of the interactive and personalized features that characterize this program.

A process evaluation of the Friendships and Dating Program for adults with developmental disabilities: measuring the fidelity of program delivery.

Adults with intellectual and developmental disabilities are frequently abused in dating and partnered relationships. The Friendships and Dating Program (FDP) was developed to prevent violence in dating and partnered relationships and to teach social skills needed to develop healthy, meaningful relationships among this population. A pilot study indicated the FDP resulted in a statistically significant increase in social network size and a significant decrease in instances of interpersonal violence. This study focused on utilizing a Process Evaluation Model (PEM) to document the level of treatment fidelity in the delivery of the 20 session FDP for adults with intellectual and developmental disabilities delivered by community agency personnel. The PEM also documented the amount of content delivered to the participants during each session. Results indicated that direct service personnel delivered the program with a high level of fidelity. Additionally, participants engaged at high rates over the course of the 10-week program. Further, the results indicated the FDP topics and methods of delivery were appropriate for adults with intellectual and developmental disabilities. Programs should use a Process Evaluation Model (PEM) and methods as a routine quality control mechanism to assess provision of salient participant procedures.

Applied social and behavioral science to address complex health problems.

Complex and dynamic societal factors continue to challenge the capacity of the social and behavioral sciences in preventive medicine and public health to overcome the most seemingly intractable health problems. This paper proposes a fundamental shift from a research approach that presumes to identify (from highly controlled trials) universally applicable interventions expected to be implemented "with fidelity" by practitioners, to an applied social and behavioral science approach similar to that of engineering. Such a shift would build on and complement the recent recommendations of the NIH Office of Behavioral and Social Science Research and require reformulation of the research-practice dichotomy. It would also require disciplines now engaged in preventive medicine and public health practice to develop a better understanding of systems thinking and the science of application that is sensitive to the complexity, interactivity, and unique elements of community and practice settings. Also needed is a modification of health-related education to ensure that those entering the disciplines develop instincts and capacities as applied scientists.

Effectiveness of Smoking Cessation and Reduction in Pregnancy Treatment (SCRIPT) methods in Medicaid-supported prenatal care: Trial III.

This two-phase evaluation documented the delivery and effectiveness of evidence-based health education methods by regular staff to pregnant smokers. During Phase 1, a total of 436 Medicaid patients were screened and 416 (95%) gave consent: 334 nonsmokers and 102 smokers. This historical Comparison (C) group was assessed to document the "normal" pretrial smoking prevalence, patient nondisclosure (deception), and cessation rates at the first prenatal visit and during care. After this study, a formative evaluation of SCRIPT methods was conducted among 139 experimental group patients and 126 control group patients. During Phase 2, a total of 6,514 patients were screened over a 36-month period: 1,736 (27%) were smokers and 1,340 (77%) gave consent. After randomization, 247 became ineligible. The remaining 1,093 smokers received brief routine advice to quit. The experimental group (n = 544) also received a Commit to Quit video, A Pregnant Woman's Guide to Quit Smoking, and counseling. Self-reports and saliva were collected at baseline, ≥60 days, and ≤90 days postpartum for cotinine analyses to document cessation and significant reduction (SR) rates. The Phase 1 formative evaluation documented a 24% nondisclosure rate at the onset of care. It also confirmed a significantly higher experimental (17.3%) versus control group (8.8%) cessation rate and experimental versus control group SR rates of 22% and 16%. During Phase 2, unplanned policy changes, and delivery of experimental group counseling procedures to 15% to 20% of control group patients, resulted in a final experimental group cessation rate of 12% and a control group rate of 10%. The experimental group SR rate of 18%, however, was significantly higher than the control group SR rate of 13%. Effectiveness varied by the stability of clinic infrastructure, and degree of fidelity of staff performance of assessment and intervention procedures. The methods and results of this study will assist future health education programs for pregnant smokers to plan and conduct process and impact evaluations in prenatal care.

Motivational interviewing versus prescriptive advice for smokers who are not ready to quit.

OBJECTIVE: Smokers who are not ready to quit are a very difficult group to treat. Physicians, nurses, and nurse practitioners are in a unique position to encourage patients to quit smoking. However, the best approach to do so is not clear. METHODS: A two-group randomized controlled trial with 218 pack-a-day precontemplative and contemplative smokers recruited from the community. The laboratory-based study was designed to simulate outpatient visits to general practitioners. Participants were randomized to a 15-min intervention to compare the effectiveness of brief motivational or prescriptive counseling by a health professional. Thirteen outcome variables included intentions to quit and verbal reports at 1 and 6 months with biological verification. A composite outcome measure was constructed to provide greater power to detect study differences. RESULTS: Approximately 33% of the sample reported at least one 24-h quit period during the 6 months they were followed after the trial. Results suggest that while neither treatment was superior, there were subgroup differences. Participants in the motivational condition were also more likely to respond to follow-up calls. CONCLUSIONS AND PRACTICE IMPLICATIONS: Motivational interviewing and prescriptive advice were equally effective for precontemplative and contemplative smokers. Practitioners should use the method that appeals to them.

An impact evaluation of a federal mine safety training regulation on injury rates among US stone, sand, and gravel mine workers: an interrupted time-series analysis.

OBJECTIVES: We evaluated the impact of a safety training regulation, implemented by the US Department of Labor's Mine Safety and Health Administration (MSHA) in 1999, on injury rates at stone, sand, and gravel mining operations. METHODS: We applied a time-series design and analyses with quarterly counts of nonfatal injuries and employment hours from 7998 surface aggregate mines from 1995 through 2006. Covariates included standard industrial classification codes, ownership, and injury severity. RESULTS: Overall crude rates of injuries declined over the 12-year period. Reductions in incident rates for medical treatment only, restricted duty, and lost-time injuries were consistent with temporal trends and provided no evidence of an intervention effect attributable to the MSHA regulation. Rates of permanently disabling injuries (PDIs) declined markedly. Regression analyses documented a statistically significant reduction in the risk rate in the postintervention time period (risk rate = 0.591; 95% confidence interval = 0.529, 0.661). CONCLUSIONS: Although a causal relationship between the regulatory intervention and the decline in the rate of PDIs is plausible, inconsistency in the results with the other injury-severity categories preclude attributing the observed outcome to the MSHA regulation. Further analyses of these data are needed.

Feasibility of a tobacco cessation intervention for pregnant Alaska Native women.

BACKGROUND: Among Alaska Native women residing in the Yukon-Kuskokwim (Y-K) Delta region of Western Alaska, about 79% smoke cigarettes or use smokeless tobacco during pregnancy. Treatment methods developed and evaluated among Alaska Native pregnant tobacco users do not exist. This pilot study used a randomized two-group design to assess the feasibility and acceptability of a targeted cessation intervention for Alaska Native pregnant women. METHODS: Recruitment occurred over an 8-month period. Enrolled participants were randomly assigned to the control group (n = 18; brief face-to-face counseling at the first visit and written materials) or to the intervention group (n = 17) consisting of face-to-face counseling at the first visit, four telephone calls, a video highlighting personal stories, and a cessation guide. Interview-based assessments were conducted at baseline and follow-up during pregnancy (>or=60 days postrandomization). Feasibility was determined by the recruitment and retention rates. RESULTS: The participation rate was very low with only 12% of eligible women (35/293) enrolled. Among enrolled participants, the study retention rates were high in both the intervention (71%) and control (94%) groups. The biochemically confirmed abstinence rates at follow-up were 0% and 6% for the intervention and control groups, respectively. DISCUSSION: The low enrollment rate suggests that the program was not feasible or acceptable. Alternative approaches are needed to improve the reach and efficacy of cessation interventions for Alaska Native women.

Evaluation of the immediate impact of the Washington, D.C., smoke-free indoor air policy on bar employee environmental tobacco smoke exposure.

OBJECTIVE: On January 2, 2007, thw Washington, D. C., City Council banned smoking in restaurants and bars. We sought to determine the immediate impact of the ban on cotinine-confirmed environmental tobacco smoke (ETS) levels and respiratory symptom reports of a random sample of bar employees. METHODS: We conducted an assessment of 66 employees from 41 randomly selected bars in December 2006, a month before the ban went into effect. After analyses of baseline data, 52 employees were eligible and 49 of them (94%) had a post-ban assessment in February 2007. Three participants were excluded due to high cotinine levels at the post-ban assessment, yielding a final sample size of 46 bar employees. ETS exposure levels were documented using saliva cotinine analyses by tandem liquid chromatography and mass spectrometry. Employee respiratory and sensory symptoms reports were assessed by a standardized, validated form: the International Union Against Tuberculosis and Lung Disease Bronchial Symptoms Questionnaire. Employee ETS exposure reports at work were eliminated after the ban. RESULTS: Sensory symptoms reports (at < or = 4 weeks) declined significantly by 70% to 100% (p = 0.0016); respiratory symptoms results were inconclusive due to a lack of data. Saliva cotinine medians declined significantly by 70% (p < 0.0001), from a pre-ban mean of 2.11 nanograms per millileter (ng/mL) to a post-ban mean of 0.29 ng/mL, confirming reports of no ETS exposure at work. CONCLUSION: We concluded that the indoor air law was effective, eliminating employee ETS exposure reports, dramatically reducing their cotinine levels, and almost eliminating reports of sensory symptoms.

Getting young adults to quit smoking: a formative evaluation of the X-Pack Program.

The lack of promising smoking cessation interventions targeting young adults is a recognized public health problem. This study was designed to determine the feasibility of a young-adult-oriented program, the X-Pack Program, when administered to college student smokers, and to estimate its effect on smoking cessation. Participants (N = 83) were randomized after enrollment to receive either a moderately intensive, E-mail-based, young-adult intervention (the X-Pack group) or a less-intensive program aimed at a general adult audience (the Clearing the Air group). Participants were assessed at baseline and at 3 and 6 months after enrollment. Participants in the X-Pack group rated their treatment more favorably overall, were more engaged in program activities, and quit for more consecutive days at the 3- and 6-month follow-ups, compared with the Clearing the Air group. Differences in quit rates favored the X-Pack group at the two follow-ups, but the differences were not significant. These findings offer some support for the X-Pack Program when administered to college smokers.

Feasibility, cost, and cost-effectiveness of a telephone-based motivational intervention for underserved pregnant smokers.

This study reports on the evaluation of the feasibility, cost, and cost-effectiveness of a proactively provided telephone-based motivational smoking cessation intervention to an underserved population of pregnant smokers who may or may not receive ongoing prenatal care. As part of the New England SCRIPT randomized clinical trial comparing the efficacy of three types of smoking cessation interventions for pregnant smokers, one-third of the women (n = 358) received a motivational telephone counseling intervention (MI) delivered by trained counselors using a semistructured protocol. Although this population was very mobile, the MI counselors were able to reach 86% of the women with at least one call and 46% received all three calls. The group receiving three MI calls had a cotinine-confirmed quit rate of 23%. Cost-effectiveness analyses for those women receiving telephone counseling supported the net benefit in favor of the three phone calls compared with the women who did not receive any telephone calls, with an effectiveness to cost ratio of 1:US dollars 84. Our results suggest that telephone-based motivational smoking cessation counseling may be a feasible and cost-effective method for low-income pregnant smokers enrolled in prenatal care.

Data collection in a multisite project: Teleform.

Data collection, entry, validation, and management are salient time- and resource-consuming dimensions of all research projects. This is especially true for multisite studies, which pose unique, additional challenges because of their research design requirements. To save time and reduce the number of manual data entry errors, automated processing systems are becoming more widely used. Our research team chose Teleform for data entry and collection for the Smoking Cessation or Reduction in Pregnancy Trial study. This article presents our experience with this new technology.

Using formative evaluation to improve a smoking cessation intervention for pregnant women.

Triangulation analysis was used to assess qualitative data collected to examine smoking cessation materials and methods prior to a large randomized clinical trial with pregnant smokers. The patient education program's components were tested with 265 patients receiving Medicaid-insured care in 9 public clinics. The formative evaluation process conducted during this pilot study of the Smoking Cessation and Reduction in Pregnancy Trial included assessment of A Pregnant Woman's Guide to Stop Smoking (Windsor et al., 2002), a companion video, clinic reinforcement, and patient-centered counseling. Focus groups were conducted, with 23 (82%) of the nurses and social workers who provided the intervention. Twenty-nine (20.8%) of the women who received the intervention were interviewed individually. The qualitative data were examined to identify convergence and divergence among and between providers and patients about presentation, use of components, and program impact. Findings were used to refine the intervention to enhance patient and staff receptivity, specifically to ensure participant comprehension and shorten time required of busy staff.