Smoking Cessation Intervention in Pregnant Women
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The investigators propose an 18-month, randomized, open-label evaluation of the impact of
      texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will
      be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of
      age, are in the preparation stage of change and willing to set a quit date within 30 days and
      before 35 weeks gestation, and have a cellular phone that is capable of receiving text
      messages. Patients will be randomized to either the texting group or control group. A
      baseline carbon monoxide level will be obtained. The patient, regardless of group, will have
      the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem
      that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy
      patches or bupropion free of charge in 2-week intervals. Patients in the intervention group
      will receive text messages focused on smoking cessation and pregnancy. Patients will be seen
      on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with
      the pharmacist, and complete a carbon monoxide exhalation test. These visits will be
      continued until the pharmacotherapy course is complete.
    

Detailed description: 
      Smoking during pregnancy has been shown to have detrimental effects on both the mother and
      the fetus. The perinatal period presents a critical opportunity to educate and support the
      mother as she attempts quit. Current studies suggest a median quit rate of only 4.9% in women
      receiving usual care (Cognitive Behavioral Therapy, CBT), but a number of studies have
      investigated new interventions in addition to usual care to help increase compliance with
      smoking cessation. Pharmacological aids such as nicotine replacement therapy (NRT) and
      bupropion are recommended as potential options by the American College of Obstetrics and
      Gynecology since they are considered safer than continued smoking during pregnancy. Studies
      thus far on smoking cessation with the help of electronic devices have demonstrated mixed
      results; however, the impact of texting in the pregnant population in combination with CBT
      and pharmacological therapy has yet to be assessed.

      Smoking during pregnancy has been shown to have detrimental effects on both the mother and
      the fetus. Cigarettes contain over 3000 compounds many of which can cause risk to pregnancy.
      However, the nicotine and carbon monoxide components are of primary concern. Nicotine
      releases epinephrine, which results in a decrease in uterine blood flow and an increase in
      uterine resistance. There is also decreased production of fetal nitric oxide resulting in
      lower blood flow to the fetus and leading to decreased birth weight, length, and head
      circumference compared to non-smokers.

      Studies have proven that exposure to tobacco can increase the risk for placental abruption,
      placental previa, preterm birth, antenatal death, sudden infant death syndromes,
      attention-deficit/hyperactivity disorder and asthma. Compared to children of non-smoking
      mothers, children of mothers who smoked during pregnancy had a higher BMI and increased odds
      for being overweight at 4-years of age; however, in the children whose mother quit smoking
      during pregnancy there was no increased risk of increased BMI or being overweight compared to
      the children of non-smoking mothers. According to the data from the 2009 Pregnancy Risk
      Assessment and Monitoring System (PRAMS) approximately 12.4% of pregnant women with live
      births reported smoking during the last three months of pregnancy (PRAMS). Of the 25% of
      women who smoked in the 3 months prior to pregnancy, 52% quit during pregnancy; of those, 44%
      relapsed within 6 months after delivery. The perinatal period presents a critical opportunity
      to educate and support the mother as she attempts quit.

      Current studies evaluating rates of smoking cessation in pregnant women show less than ideal
      results. A primary analysis of 12 pooled trials found a median quit rate of 4.9% in women
      with usual care. This rate increased to 13.2% in patients that received tailored self-help
      intervention.12 To help increase compliance with cessation, studies have investigated new
      interventions as part of the usual care provided to pregnant patients that continue to smoke.
      One study looked at including a 15-minute video and provider prompting at baseline and one
      month. Although a higher percentage of patients in the intervention group had a higher 30-day
      abstinence rate at 2-months post baseline, the finding was not significant (26.1% vs 10.5%,
      p=0.12) although the study did not discuss if this was an appropriately powered sample size.
      Another study looking at the combination of smoking cessation education, physical activity
      counseling and supervised exercise found a 25% abstinence rate at 8-months gestation. The use
      of NRT has also been studied. One study found that CBT plus NRT verses CBT alone was
      effective at 7-weeks (24% vs 8%, p=0.02) and 38-weeks' gestation (18% vs 7%, p=0.04),
      unfortunately there was no benefit at 3-months post-partum (20% vs. 14%, p=0.55).

      The use of pharmacological aids for smoking cessation is recommended as a potential option by
      the American College of Obstetrics and Gynecology. Currently, NRT products and bupropion are
      appropriate options during pregnancy and are the most utilized therapy for cessation during
      pregnancy. Although classified as pregnancy category-D medication, NRT patches are often used
      to assist the pregnant patient in smoking cessation when CBT is not successful. A review
      looking at 4-studies that examined pregnancy outcomes after NRT, found a significant decrease
      in the risk of preterm delivery and low-birth weight compared to active smokers. NRT is
      considered safer than continued smoking since it only provides nicotine whereas smoking
      provides nicotine plus over 3000 other chemicals. It has also improved cessation rates near
      the quit date compared to CBT in obstetric patients. Similarly, bupropion has improved
      cessation rates in non-obstetric patients and has not been associated with malformations or
      abnormal pregnancy outcomes.

      The transtheoretical stages of change assessment is beneficial to help determine a patient's
      readiness to quit. Data has shown that the stages predict preparation for cessation and
      successful cessation. In the precontemplative stage, patients are not willing to consider
      smoking cessation. The contemplative stage is defined as patients considering smoking
      cessation but not ready to set a quit date. Preparation stage occurs when patient is ready to
      set a quit date within the next 30 days. In the action stage, patients have been smoke free
      for less than six months. Maintenance stage is cessation longer than 6 months. Relapse is
      when patients have starting smoking again after being in the action stage. In other obstetric
      smoking cessation literature, relapse has been defined as smoking more than 5 cigarettes or
      smoking more than 5 times since cessation.

      Mobile technology is common place in today's society. According to the 2013 Nielsen report,
      94% of all Americans 16 years of age or older use a cellular phone with more than half of
      those being smart phones. A total of 96% of phone owners have a data plan included. In 2012,
      the average monthly usage included 164.5 calls, 644.1 voice minutes, and 764.2 text messages.
      Ownership of cell phones and high tech devices extends to all socioeconomic classes, and the
      ease and affordability has made cell phone use common for all races and income brackets. When
      looking at text message specifically for race 79% of whites, 85% of Blacks and 87% of
      Hispanics report text messaging. When looking at household income 78% of those making < 30K,
      80% of those making between 30k-50k, and 88% of those making greater than 50k are active
      texters. African Americans are more likely than the general population to own smart phones
      (71% vs. 62%) and are 44% more likely than the broader market to create a social media
      profile. Over a monthly basis, African Americans also spend 24% more time on their phone ,
      12% more time on email, and 10% more time on the internet. Hispanics text the greatest of all
      ethnic groups at 943 text messages per month. Based on this data, it is apparent that mobile
      phone messaging is a potential convenient and cost-effective way to interact with patients of
      all races and income levels.

      Results of current studies looking at smoking cessation with the help of computer or other
      electronic device are mixed. Several trials have looked at the use of text-messaging based
      smoking cessation programs. One randomized controlled pilot trial of 151 daily smokers
      interested in quitting found a non-clinically significant difference in cessation rates at 3
      months between the intervention and control groups (11% versus 4%), this study was not
      powered to detect a statistical difference. A small pilot study evaluating Text2Quit, an
      automated, personalized, and interactive program that sends texts and emails over the course
      of 3 months, reported liking the program at 2 and 4 weeks after enrollment (91% and 82%,
      respectively) and 75% of participants reported reading most or all of the messages sent.
      Unfortunately, the majority of participants admitted to smoking at the 4-week visit. The
      txt2stop study was a trial of 5800 smokers that were randomized to receive text messages that
      were comprised of motivational and behaviour-change support versus the control group who
      received text messages unrelated to quitting. At 6-months abstinence was significantly
      increased in the intervention group versus the control group (10.7% vs. 4.9%; p<0.0001).
    

Intervention name(s): text messages focused on smoking cessation and pregnancy
Intervention type(s): Behavioral
Intervention description(s): The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care