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.

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.

Communication Coaching in Cardiology (CCC): A study protocol and methodological challenges and solutions of a randomized controlled trial in outpatient cardiology clinics.

Given the role of effective communication in improving patient adherence and satisfaction, high quality patient-clinician communication is critical. Building on previous communication interventions in oncology and pediatrics, we developed a tailored communication coaching intervention to improve empathic communication quality and patient-centered care. In this randomized controlled trial, cardiologists record their patient encounters for review by a communication coach who provides tailored feedback. We are recruiting 40 cardiologists and 400 patients, or 4 patients per cardiologist in the Pre-intervention phase and 6 patients per cardiologists in the Post-intervention phase, from outpatient cardiology clinics within the Duke Health System. The primary goal of the trial is to determine the efficacy of the clinician communication coaching versus usual care in the post-intervention phase (240 patient encounters). In this paper, we describe the development of the communication coaching intervention. We also describe the details of the methods and outcomes of the ongoing trial. Finally, we discuss the challenges, solutions, and lessons learned during the start-up phase of the study.