Effects of Smoking Reduction and Cessation on Birth Outcomes in a Scheduled Gradual Reduction Cessation Trial.

INTRODUCTION: Smoking during pregnancy can affect infant birthweight. We tested whether an intervention that promoted scheduled gradual reduction improved birth outcomes among pregnant women who smoked. We also examined race differences in birth outcomes. METHODS: We conducted a 2-arm randomized controlled trial where pregnant women who smoked received either SMS text-delivered scheduled gradual smoking reduction (SGR) program plus support texts or support messages only throughout their pregnancy. The outcomes for this paper were birth outcomes including birth weight and gestational age obtained from chart review. Analyses were conducted using chi-square and t-tests in SAS. RESULTS: We approached 2201 pregnant women with smoking history. Of the 314 women recruited into the study, 290 completed a medical release form (92%). We did not find any significant differences in birth outcomes by arm or race. The majority of participants reduced smoking by the 80%. Women who reduced more than 50% of their baseline cigarettes per day had a birth weight increase of 335 g compared to those that did not (p = 0.05). The presence of alcohol/drug use in prenatal visit notes was associated with low infant birth weight (p = 0.05). DISCUSSION: The scheduled gradual reduction intervention did not improve birth outcomes. Additional research is needed to help improve birth outcomes for pregnant women who engage in tobacco and illicit substance use. CLINICAL TRIAL #: NCT01995097.

Triadic agreement about advanced cancer treatment decisions: Perceptions among patients, families, and oncologists.

OBJECTIVES: When patients make cancer treatment decisions, they consider the needs and preferences of family caregivers and clinicians. We examined how much all three triad members agreed about goals of treatment and caregivers' influence on decision-making. METHODS: We surveyed 70 triads of patients, caregivers, and oncologists who had recently made an advanced cancer treatment decision. We assessed each triad member's perception of the goal of treatment and the caregiver's influence on the decision. Participants also completed scales related to decisional conflict, satisfaction, and regret. RESULTS: In only 28/70 triads (40%), all three agreed on the goal of treatment with the most common goal being to live longer (n = 22). Whereas patients and caregivers tended to think the goal was to cure or live longer, oncologists were less optimistic. In only 22 triads (31%), all three agreed on how much influence the caregiver had on decision-making. Oncologists tended to underestimate caregiver influence. Patients and caregivers had low decisional conflict (M=15.40, SD=4.51; M=17.09, SD=6.34, respectively). CONCLUSIONS: Advanced cancer treatment decision-making occurs amid incomplete understanding among patients, caregivers, and oncologists. PRACTICE IMPLICATIONS: Confirming agreement about goals of care and influence on treatment decision-making may increase the likelihood of goal-concordant care throughout the illness trajectory.

Trajectories of Situational Temptations in Pregnant Smokers participating in a Scheduled Gradual Reduction Cessation Trial.

OBJECTIVE: The purpose of this paper was to examine changes in situational temptations to smoke among women in early to late pregnancy enrolled in a texting trial to help them quit smoking. We compared changes between (1) intervention arms, (2) those who quit, (3) those who reduced by 50% or more, and (4) those who reduced by less than 50%. We also examined cravings overtime in the intervention arm and the relationship between real-time cravings assessed via text message and situational temptations. METHODS: This was a secondary analysis of the Baby Steps trial, a randomized controlled trial testing the efficacy of a text-based scheduled gradual reduction (SGR) intervention on cessation. We used t-tests to examine changes across intervention arms and repeated measured proc mixed to explore changes in situational temptations and cravings. RESULTS: Among all women, situational temptations decreased from early to late pregnancy for the positive, negative, and habitual subscales, (ps < 0.001). We found no difference in situational temptations across arms. We found a positive relationship between negative situational temptation and average craving during the Weeks 2 and Weeks 3 of the intervention. Negative ST increased by 0.11 for each unit increase of craving at Week 2. CONCLUSIONS: As women progress through pregnancy their temptation to smoke reduces. A different relationship might exist, however with negative affect situations in which women reported higher craving but not in response to other temptations. Future work might have a particular focus on the intersection of negative affect with cravings and temptations to promote cessation during pregnancy. CLINICAL TRIAL: NCT01995097.

Pilot Test of Connecting Pregnant Women who Smoke to Short Message Service (SMS) Support Texts for Cessation.

INTRODUCTION: Most pregnant women know that smoking poses serious risks to baby and mother, yet many still smoke. We conducted a large randomized controlled trial and found that an SMS text-delivered program helped about 10% of these women quit smoking. In this paper, we describe the feasibility of disseminating a text-based intervention to pregnant women who smoke. METHODS: We tested dissemination in two ways from prenatal clinics and compared recruitment rates to those found in our large randomized controlled trial. The first method involved "direct texting" where study staff identified women who smoked and sent them a text asking them to text back if they wanted to receive texts to help them quit. The second involved "nurse screening" where clinic staff from county health departments screened women for smoking and asked them to send a text to the system if they wanted to learn more about the program. Our primary outcome was feasibility assessed by the number of women who texted back their baby's due date, which served as "enrolling" in the texting program, which we compared to the recruitment rate we found in our large trial. RESULTS: Over 4 months, we texted 91 women from the academic health system. Of those, 17 texted back and were counted as "enrolled." In the health departments, across the 4 months, 12 women texted the system initially. Of those, 10 were enrolled. This rate was similar to the rate enrolled in the randomized controlled trial. DISCUSSION: Two different methods connected pregnant women who smoke to a texting program. One of these methods can be automated further and have the potential of helping many women quit smoking with minimal effort. Clinical Trial # NCT01995097.

Efficacy of a Texting Program to Promote Cessation Among Pregnant Smokers: A Randomized Control Trial.

INTRODUCTION: Smoking during pregnancy poses serious risks to baby and mother. Few disseminable programs exist to help pregnant women quit or reduce their smoking. We hypothesized that an SMS text-delivered scheduled gradual reduction (SGR) program plus support texts would outperform SMS support messages alone. METHODS: We recruited 314 pregnant women from 14 prenatal clinics. Half of the women received theory-based support messages throughout their pregnancy to promote cessation and prevent relapse. The other half received the support messages plus alert texts that gradually reduced their smoking more than 3-5 weeks. We conducted surveys at baseline, end of pregnancy, and 3 months postpartum. Our primary outcome was biochemically validated 7-day point prevalence abstinence at late pregnancy. Our secondary outcome was reduction in cigarettes per day. RESULTS: Adherence to the SGR was adequate with 70% responding to alert texts to smoke within 60 minutes. Women in both arms quit smoking at the same rate (9%-12%). Women also significantly reduced their smoking from baseline to the end of pregnancy from nine cigarettes to four; we found no arm differences in reduction. CONCLUSIONS: Support text messages alone produced significant quit rates above naturally occurring quitting. SGR did not add significantly to helping women quit or reduce. Sending support messages can reach many women and is low-cost. More obstetric providers might consider having patients who smoke sign up for free texting programs to help them quit. IMPLICATIONS: A disseminable texting program helped some pregnant women quit smoking.Clinical Trial Registration number: NCT01995097.

The Co-occurrence of Daily Smoking, Binge Drinking and IPV Among Latino Expectant Fathers.

Many Latino men have multiple risk factors that predispose them to chronic disease morbidity and mortality, yet few have examined patterns in this population. We describe the co-occurrence of daily smoking, binge drinking, and intimate partner violence (IPV) behaviors among Latino expectant fathers and examine factors associated with the co-occurrence of these behaviors. We conducted a secondary analysis of baseline data from the Parejas Trial, a randomized controlled trial testing a culturally tailored couples-based smoking cessation intervention. We used Kruskal-Wallis test statistics to explore the relationship of the co-occurring behavior and demographic and cultural factors. All participants smoked as was a requirement of being in the trial, but only 39% smoked daily. Forty three percent of the participants engaged in one behavior, 32% engaged in two behaviors, and 5% engaged in three behaviors, with binge drinking being the most common co-occurring behavior. In the bivariate analysis, higher stress (p = 0.01) and having more children (p = 0.003) were found to be positively significantly associated with the number of behaviors. Helping Latino expectant fathers manage with their stress may serve as tailoring points for future interventions to reduce risk behaviors.

A smoking cessation and pain management program for cancer survivors.

PURPOSE: Many cancer survivors continue to smoke. Further, most survivors also report high levels of persistent pain and smoke in response to pain. The investigators tested the feasibility, acceptability, and preliminary efficacy of a smoking cessation program paired with a pain management program for cancer survivors. METHODS: The investigators conducted a two-arm, wait-list randomized controlled pilot study in which they delivered a combined smoking cessation and pain management intervention. RESULTS: The investigators randomized 30 survivors (14 intervention and 16 wait-list control). Seventy-one percent of the survivors who received the intervention rated it as extremely useful (5 out of 5) in helping them quit smoking. Further, 86% would recommend the program to other survivors. Although we could not conduct inferential statistics, 14% of those in the intervention arm, compared to 6% in the control condition had biochemically validated cessation at 2-months post-randomization. Survivors in the intervention also reported less pain, had improvements in depressive symptoms, and better physical function than those in the control arm. CONCLUSIONS: Our pilot data suggest the feasibility, acceptability, and preliminary efficacy of this approach. The next step is to conduct a large randomized controlled trial to fully test the efficacy of the intervention. IMPLICATIONS FOR CANCER SURVIVORS: A combined smoking cessation and pain program might help improve both issues simultaneously.

Pilot randomized trial of a couple-based physical activity videoconference intervention for sedentary cancer survivors.

OBJECTIVE: Including partners in interventions to increase physical activity (PA) could promote better adherence and longer-term effects. In preparation for a future large-scale randomized controlled trial (RCT), this randomized pilot trial tested the acceptability of a novel couple-based PA intervention for breast and prostate cancer survivors and the feasibility of conducting an RCT testing the intervention. METHOD: Twenty cancer survivors (70% female; mean age = 63.0 years, SD = 8.9) and their partners (35% female; mean age = 62.8 years, SD = 7.7) were randomized to either the intervention or waitlist control. Couples in the intervention received four videoconference sessions including training in communication and support skills and behavior change techniques. Measures of PA and partner support for exercise were collected from survivors and partners before randomization and postintervention. Survivors also completed a physical well-being measure, and intervention participants completed a treatment acceptability measure. RESULTS: Recruitment was challenging; approximately 18% of eligible survivors and their partners agreed to participate. Ninety-two percent of randomized participants completed postintervention surveys, and 78% of dyads randomized to the intervention arm completed all 4 sessions. Mean acceptability ratings were moderate to high. Mean difference scores suggested that participants in the intervention arm tended to report greater improvements in PA, partner support, and physical well-being than those in the control arm. CONCLUSIONS: These preliminary findings suggest that the couple-based PA intervention was acceptable to survivors and their partners and that a large-scale RCT is likely to be feasible with modified recruitment strategies. Recommendations for improving recruitment and conducting a larger study are presented. (PsycINFO Database Record

Accuracy and congruence of physician and adolescent patient weight-related discussions: Teen CHAT (Communicating health: Analyzing talk).

OBJECTIVE: We assessed the accuracy and congruence of recall of weight topics during clinical encounters between adolescent patients with overweight/obesity and physicians (randomized to Motivational Interviewing education vs. control arm). METHODS: We audio recorded 357 clinic encounters and coded topics of weight, physical activity (PA), breakfast, and fast food. We assessed recall accuracy/congruence. Generalized estimation equation modeling assessed associations between selected factors and recall accuracy. RESULTS: Accuracy for physicians was: weight (90%), PA (88%), breakfast (77%) and fast food (70%). Patient accuracy was: weight (94%), PA (94%), breakfast (73%) and fast food (61%). Physician/patient congruence was: weight (89%), PA (90%), breakfast (71%) and fast food (67%). Use of a reminder report indicating adolescent's weight behaviors in the physician control group resulted in increased adolescent (p = 0.02) and physician accuracy (p = 0.05) for fast food. Adolescents were more likely to recall discussions of fast food (odds ratio, 0.87; 95% CI, 0.77-0.97) as encounter time decreased; male adolescents were less likely to recall breakfast than females (odds ratio, 0.52; 95% CI, 0.28-0.95). CONCLUSION: Adolescents and physicians recall weight and PA more often, perhaps indicating greater engagement in these topics. PRACTICE IMPLICATIONS: Reminder reports might possibly enhance discussion and recall of diet related messages.

Physician Weight-Related Counseling Is Unrelated to Extreme Weight Loss Behaviors Among Overweight and Obese Adolescents.

Some physicians may be hesitant to counsel overweight and obese adolescents about weight because of concerns that such counseling may result in extreme weight loss behaviors and the subsequent development of eating disorders. We compared self-reported extreme weight loss behaviors in 535 overweight/obese adolescents prior to receiving weight-related counseling during primary care visits, and again after 3 months. We found no change in fasting (7.7% vs 6.3%, P = .45), and decreases in diet pill use (4.1% vs 1.7%, P = .003) and laxative use/vomiting (2.6% vs 1.0%, P = .02). Three months following their medical appointment, patients were also less likely to report trying to lose weight in general (80.0% vs 75.6%, P = .04). Physicians should be reassured that providing weight-related counseling to their obese adolescents is unlikely to induce extreme weight loss behaviors. Frequent counseling may be required in order to help patients maintain motivation to attain a healthy weight.

Use of the 5 As for Teen Alcohol Use.

Clinical guidelines recommend addressing adolescent alcohol use in primary care; the 5 As (Ask, Advise, Assess, Assist, Arrange) may be a useful model for intervention. We audio-recorded 540 visits with 49 physicians and adolescents, compared alcohol disclosure rates in the encounter with those in a survey, and analyzed conversations for use of the 5 As and their relation to adolescent reports of drinking 3 months after the encounter. When physicians asked clear, nonleading questions, drinkers were more likely to disclose alcohol use ( P = .004). In 64% of visits in which alcohol was discussed, physicians used one or more of the 5 As, most frequently "Ask." No physician used all 5 As. Among drinkers, there was no association between physicians' partial use of the 5 As and adolescent alcohol consumption at 3 months. Physicians can learn more effective ways to "Ask" about alcohol use to increase disclosure of drinking and to be more comprehensive in their counseling.

Teaching primary care physicians the 5 A's for discussing weight with overweight and obese adolescents.

OBJECTIVE: We developed an online intervention to teach physicians both MI (addressed in outcomes paper) and the 5 A's (Ask, Advise, Assess, Assist, and Arrange) when discussing weight with overweight/obese adolescents. METHODS: We audio recorded 527 encounters between adolescents and physicians and coded the 5 A's during weight/BMI discussions. Half of physicians were randomized to receive a tailored, intervention that included their own audio-recorded clips. To examine arm differences, we used multilevel linear mixed-effects models for sum of 5 A's and generalized estimating equations (GEE) models with a logit link for each of the A's separately. RESULTS: Intervention arm physicians used more A's than control physicians (estimated difference=0.6; 95%CI(0.2,1.0);p=0.001). Intervention physicians used Assess (p=0.004), Assist (p=0.001) and Arrange (p=0.02) more when compared to control arm physicians. CONCLUSION: An online intervention increased physicians' use of the 5 A's when discussing weight with overweight adolescents. These results are promising as the online intervention improved performance for the three A's that are infrequently used (Assess, Assist, and Arrange) yet have the most impact. PRACTICE IMPLICATIONS: A tailored online program can increase physicians' use of the 5 A's behavioral counseling approach in clinical practice with adolescents.

Teaching Physicians Motivational Interviewing for Discussing Weight With Overweight Adolescents.

PURPOSE: We tested whether an online intervention combined with a patient feedback report improved physicians' use of motivational interviewing (MI) techniques when discussing weight with overweight and obese adolescents. METHODS: We randomized 46 pediatricians and family physicians and audio recorded 527 patient encounters. Half of the physicians received an individually tailored, online intervention. Then, all physicians received a summary report detailing patient's weight-related behaviors. We coded MI techniques and used multilevel linear mixed-effects models to examine arm differences. We assessed patients' motivation to change and perceived empathy after encounter. RESULTS: We found arm differences in the Intervention Phase and the Summary Report Phase: Empathy (p < .001), MI Spirit (p < .001), open questions (p = .02), and MI consistent behaviors (p = .04). Across all three phases (Baseline, Intervention, and Summary Report), when physicians had higher Empathy scores, patients were more motivated to change diet (p = .03) and physical activity (p = .03). In addition, patients rated physicians as more empathic when physicians used more MI consistent techniques (p = .02). CONCLUSIONS: An individually tailored, online intervention coupled with a Summary Report improved physicians' use of MI, which improved the patient experience.

Efficacy of a Nurse-Delivered Intervention to Prevent and Delay Postpartum Return to Smoking: The Quit for Two Trial.

INTRODUCTION: Most pregnant women who quit smoking return to smoking postpartum. Trials to prevent this return have been unsuccessful. We tested the efficacy of a nurse-delivered intervention in maintaining smoking abstinence after delivery among pregnant women who quit smoking that was tailored on their high risk of relapse (eg, had strong intentions to return). METHODS: We recruited 382 English-speaking spontaneous pregnant quitters from 14 prenatal clinics and randomized them to receive either a smoking abstinence booklet plus newsletters about parenting and stress (control) or a nurse-delivered smoking abstinence intervention that differed in intensity for the high and low risk groups. Our primary outcome was smoking abstinence at 12 months postpartum. RESULTS: Using intent-to-treat analyses, there was a high rate of biochemically validated smoking abstinence at 12 months postpartum but no arm differences ( CONTROL: 36% [95% confidence interval [CI]: 29-43] vs. INTERVENTION: 35% [95% CI: 28-43], P = .81). Among women at low risk of returning to smoking, the crude abstinence rate was significantly higher in the control arm (46%) than in the intervention arm (33%); among women at high risk of returning to smoking, the crude abstinence rate was slightly lower but not different in the control arm (31%) than in the intervention arm (37%). CONCLUSIONS: Low-risk women fared better with a minimal intervention that focused on parenting skills and stress than when they received an intensive smoking abstinence intervention. The opposite was true for women who were at high risk of returning to smoking. Clinicians might need to tailor their approach based on whether women are at high or low risk of returning to smoking. IMPLICATIONS: Results suggest that high-risk and low-risk women might benefit from different types of smoking relapse interventions. Those who are lower risk of returning to smoking might benefit from stress reduction that is devoid of smoking content, whereas those who are higher risk might benefit from smoking relapse prevention.

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices.

OBJECTIVE: Studies indicate needed improvement in clinician communication and patient satisfaction. Motivational interviewing (MI) helps promote patient behavior change and improves satisfaction. In this pilot study, we tested a coaching intervention to teach MI to all clinic staff to improve clinician and patient satisfaction. METHODS: We included four clinics (n=29 staff members). In the intervention clinics (one primary care and one pediatric obesity-focused), we trained all clinic staff in MI through meetings as a group seven times, directly observing clinicians in practice 4-10 times, and providing real-time feedback on MI techniques. In all clinics, we assessed patient satisfaction via anonymous surveys and also assessed clinician burnout and self-rated MI skills. RESULTS: Clinicians in the intervention clinics reported improvements in burnout scores, self-rated MI skills, and perceived cohesion whereas clinicians in the control clinic reported worse scores. Patient satisfaction improved in the intervention clinics more than in the control clinics. CONCLUSION: This is the first study to find some benefit of training an entire clinic staff in MI via a coaching model. PRACTICE IMPLICATIONS: It might help to train staff in MI to improve clinician satisfaction, team cohesion, perceived skills, and patient satisfaction.

Studying physician-adolescent patient communication in community-based practices: recruitment challenges and solutions.

BACKGROUND: Practice-based studies are needed to assess how physicians communicate health messages about weight to overweight/obese adolescent patients, but successful recruitment to such studies is challenging. This paper describes challenges, solutions, and lessons learned to recruit physicians and adolescents to the Teen Communicating Health Analyzing Talk (CHAT) study, a randomized controlled trial of a communication skills intervention for primary care physicians to enhance communication about weight with overweight/obese adolescents. MATERIALS AND METHODS: A "peer-to-peer" approach was used to recruit physicians, including the use of "clinic champions" who liaised between study leaders and physicians. Consistent rapport and cooperative working relationships with physicians and clinic staff were developed and maintained. Adolescent clinic files were reviewed (HIPAA waiver) to assess eligibility. Parents could elect to opt-out for their children. To encourage enrollment, confidentiality of audio recordings was emphasized, and financial incentives were offered to all participants. RESULTS: We recruited 49 physicians and audio-recorded 391 of their overweight/obese adolescents' visits. Recruitment challenges included 1) physician reticence to participate; 2) variability in clinic operating procedures; 3) variability in adolescent accrual rates; 4) clinic open access scheduling; and 5) establishing communication with parents and adolescents. Key solutions included the use of a "clinic champion" to help recruit physicians, pro-active, consistent communication with clinic staff, and adapting calling times to reach parents and adolescents. CONCLUSION: Recruiting physicians and adolescents to audio-recorded, practice-based health communication studies can be successful. Anticipated challenges to recruiting can be met with advanced planning; however, optimal solutions to challenges evolve as recruitment progresses.

Efficacy of a couple-based randomized controlled trial to help Latino fathers quit smoking during pregnancy and postpartum: the Parejas trial.

BACKGROUND: Although many Latinos in the United States smoke, they receive assistance to quit less often than non-Latinos. To address this disparity, we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment, when men's partners were pregnant. METHODS: We compared two interventions: (i) written materials plus nicotine replacement therapy (NRT) to (ii) materials, NRT, and couple-based counseling that addressed smoking cessation and couples communication. We recruited 348 expectant fathers who smoked via their pregnant partners from county health departments. Our primary outcome was 7-day point prevalence smoking abstinence and was collected from November 2010 through April 2013 and analyzed in February 2014. RESULTS: We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy (0.31 vs. 0.30, materials only vs. counseling, respectively) and 12 months after randomization (postpartum: 0.39 vs. 0.38). We found high quit rates among nondaily smokers but no arm differences (0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum). Among daily smokers, we found lower quit rates with no arm differences but effects favoring the intervention arm (0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum). CONCLUSIONS: A less intensive intervention promoted cessation equal to more intensive counseling. Postpartum might be a more powerful time to promote cessation among Latino men. IMPACT: Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities.